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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97467

27 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 20, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

27 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 27

ACCOLADE SR SL (Model L300)

Z-0079-2026
Recall number
Z-0079-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
16,077 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

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Distribution pattern

Worldwide

device · product 2 of 27

ACCOLADE DR SL (Model L301)

Z-0080-2026
Recall number
Z-0080-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
32,695 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526558924, Serial Numbers: 100056, 100092, 100111, 100120, 100122, 100125, 100127, 100134, 100136, 100137, 100142, 100144, 100147, 100154, 100156, 100160, 100161, 100162, 100168, 100177, 100179, 100183, 100184, 100185, 100190, 100192, 100200, 100206, 100207, 100214, 100217, 100224, 100226, 100227, 100230, 100231, 100234, 100235, 100236, 100237, 100238, 100246, 100253, 100255, 100258, 100261, 100268, 100269, 100277, 100279, 100284, 100285, 100288, 100291, 100293, 100299, 100302, 100303, 100304, 100307, 100313, 100316, 100323, 100326, 100334, 100337, 100341, 100342, 100344, 100345, 100353, 100355, 100356, 100359, 100366, 100368, 100373, 100374, 100377, 100388, 100389, 100391, 100394, 100396, 100399, 100402, 100411, 100419, 100421, 100426, 100428, 100429, 100437, 100440, 100441, 100445, 100447, 100448, 100449, 100450, 100454, 100456, 100457, 100460, 100467, 100468, 100469, 100472, 100474, 100475, 100491, 100493, 100497, 100498, 100499, 100501, 100502, 100503, 100505, 100507, 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Distribution pattern

Worldwide

device · product 3 of 27

ACCOLADE SR SL MRI (Model L310)

Z-0081-2026
Recall number
Z-0081-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
50,135 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526558948, Serial Numbers: 701140, 701954, 702152, 702176, 702278, 702560, 702997, 702998, 703023, 703075, 703125, 703128, 703138, 703169, 703172, 703201, 703203, 703251, 703253, 703272, 703307, 703324, 703331, 703343, 703395, 703427, 703447, 703451, 703458, 703504, 703508, 703534, 703538, 703546, 703547, 703628, 703656, 703754, 703790, 703839, 704235, 704285, 704300, 704307, 704351, 704493, 704495, 704563, 704590, 704877, 705061, 705070, 705078, 705085, 705105, 705130, 705163, 705169, 705192, 705196, 705225, 705253, 705261, 705270, 705443, 705446, 705523, 705526, 705529, 705541, 705545, 705546, 705573, 705579, 705584, 705587, 705593, 705612, 706491, 707091, 707196, 707376, 707777, 708269, 708354, 709408, 709434, 709521, 709549, 709575, 709578, 709659, 709678, 709687, 709710, 709744, 709750, 709773, 709794, 709813, 709824, 709844, 709862, 709905, 709918, 709930, 709945, 709949, 709950, 709962, 709972, 709986, 710005, 710006, 710014, 710027, 710035, 710036, 710046, 710047, 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Distribution pattern

Worldwide

device · product 4 of 27

ACCOLADE DR SL MRI (Model L311)

Z-0082-2026
Recall number
Z-0082-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
90,931 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526558962, Serial Numbers: 200737, 202944, 203132, 203273, 203512, 203621, 203903, 204448, 204712, 204767, 204877, 204938, 205006, 205007, 205020, 205029, 205055, 205063, 205068, 205069, 205076, 205077, 205079, 205088, 205116, 205218, 205226, 205261, 205328, 205330, 205339, 205354, 205355, 205375, 205398, 205400, 205423, 205457, 205515, 205544, 205552, 205601, 205613, 205633, 205642, 205645, 205651, 205656, 205668, 205694, 205699, 205705, 205713, 205716, 205717, 205719, 205728, 205772, 205778, 205808, 205816, 205818, 205830, 205833, 205835, 205838, 205870, 205896, 205956, 205983, 205995, 206085, 206094, 206117, 206123, 206144, 206152, 206157, 206252, 206260, 206265, 206285, 206325, 206375, 206404, 206408, 206411, 206505, 207204, 207462, 207887, 208016, 208046, 208192, 208212, 208325, 208368, 208372, 208379, 208434, 208449, 208461, 208465, 208471, 208489, 208632, 208636, 208651, 208658, 208690, 208788, 208952, 209027, 209089, 209115, 209132, 209185, 209198, 209201, 209214, 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Distribution pattern

Worldwide

device · product 5 of 27

ACCOLADE DR EL (Model L321)

Z-0083-2026
Recall number
Z-0083-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
7,488 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526558986, Serial Numbers: 100004, 100005, 100033, 100051, 100054, 100058, 100075, 100076, 100092, 100106, 100107, 100109, 100111, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100125, 100127, 100128, 100130, 100132, 100133, 100134, 100135, 100137, 100141, 100144, 100147, 100149, 100150, 100158, 100159, 100160, 100161, 100162, 100164, 100165, 100168, 100169, 100173, 100175, 100177, 100178, 100179, 100181, 100182, 100184, 100186, 100187, 100188, 100190, 100191, 100193, 100195, 100197, 100199, 100202, 100206, 100209, 100212, 100215, 100220, 100223, 100227, 100228, 100231, 100233, 100234, 100235, 100236, 100237, 100238, 100239, 100241, 100242, 100243, 100244, 100245, 100246, 100248, 100249, 100250, 100251, 100253, 100255, 100257, 100259, 100260, 100261, 100262, 100265, 100266, 100267, 100273, 100274, 100277, 100280, 100281, 100283, 100286, 100287, 100288, 100289, 100291, 100294, 100295, 100299, 100300, 100337, 100339, 100341, 100344, 100348, 100350, 100351, 100353, 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GTIN 00802526558993, Serial Numbers: 702303. GTIN 00802526558986, Serial Numbers: 705212, 710438, 719162, 721673. GTIN 00802526558993, Serial Numbers: 100003, 100007, 100008, 100010, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100019, 100020, 100022, 100023, 100025, 100027, 100028, 100032, 100034, 100036, 100037, 100038, 100039, 100040, 100041, 100043, 100045, 100046, 100047, 100048, 100050, 100052, 100053, 100056, 100057, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100077, 100078, 100079, 100080, 100081, 100082, 100084, 100085, 100086, 100088, 100089, 100090, 100091, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100114, 100140, 100148, 100153, 100154, 10

Distribution pattern

Worldwide

device · product 6 of 27

ACCOLADE DR EL MRI (Model L331)

Z-0084-2026
Recall number
Z-0084-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
34,180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559006, Serial Numbers: 102138, 102172, 102192, 102209, 102210, 102229, 102231, 102232, 102233, 102237, 102239, 102243, 102255, 102256, 102261, 102263, 102265, 102266, 102267, 102269, 102273, 102274, 102277, 102290, 102358, 102389, 102392, 102422, 102435, 102438, 102441, 102445, 102448, 102460, 102464, 102466, 102474, 102503, 102513, 102564, 102624, 102625, 110031, 110032, 110057, 110099, 110165, 110168, 110174, 110176, 110261, 110262, 110280, 110293, 110318, 110371, 110433, 110436, 110496, 110507, 110517, 110550, 110718, 110749, 110768, 110814, 110837, 110841, 110846, 110865, 110876, 110932, 110933, 110938, 110939, 110953, 110965, 110984, 110985, 110989, 111044, 111074, 111095, 111104, 111116, 111143, 111160, 111171, 111172, 111174, 111184, 111186, 111228, 111241, 111245, 111254, 111272, 111331, 111332, 111339, 111340, 111341, 111342, 111344, 111367, 111375, 111383, 111398, 111399, 111405, 111410, 111411, 111427, 111484, 111497, 111499, 111500, 111502, 111503, 111504, 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Distribution pattern

Worldwide

device · product 7 of 27

PROPONENT SR SL (Model L200)

Z-0085-2026
Recall number
Z-0085-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
1380 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559020, Serial numbers: 722605, 722614, 722634, 722647. GTIN 00802526576362, Serial numbers: 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464576, 708351, 708451, 708466, 708471, 708495, 708513, 708514, 708515, 708516, 708517, 708525, 708529, 708532, 708533, 708536, 708618, 708619, 708620, 708622, 708623, 708624, 708625, 708627, 708630, 708651, 708653, 708654, 708655, 708656, 708658, 708660, 708737, 708751, 708764, 708783, 708816, 708824, 708826, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708912, 708920, 708922, 708924, 708929, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708952, 708959, 708960, 708967, 708968, 708969, 708976, 708980, 708983, 708997, 709003, 709009, 709011, 709015, 709024, 709025, 709037, 709040, 709041, 710248, 710517, 710627, 710705, 710754, 710765, 710771, 710772, 710788, 710789, 710790, 710824, 710825, 710831, 710889, 710905, 710907, 710910, 710916, 710931, 710954, 710980, 711315, 711412, 711640, 711655, 714062, 714644, 714688, 714708, 715328, 717903, 717931, 717934, 717941, 717948, 717950, 717951, 717965, 717976, 717981, 717982, 717992, 718007, 718009, 718138, 718522, 718780, 718783, 718937, 720309, 720504, 720556, 720597, 720650, 721983, 721991, 722012, 722438, 722565, 722689, 722724, 722756, 722967, 723456, 724170, 724319, 724398, 724404, 724485, 724623, 725175, 725182, 725198, 725262, 725272, 725283, 725363, 725365, 725368, 725370, 725371, 725372, 725373, 725383, 725388, 725389, 725390, 725392, 725404, 725409, 725418, 725419, 725425, 725444, 727098, 728855, 728893, 728894, 728917, 728922, 729054, 729410, 729411, 729413, 729421, 729589, 729599, 729602, 731110, 731612, 734834. GTIN 00802526578007, Serial Numbers: 464370, 464388, 464446, 464452, 464458, 464460, 464467, 464468, 464470, 464475, 464477, 464481, 464482, 464483, 464486, 464490, 464491, 464492, 464498, 464500, 464501, 464506, 464508, 464512, 464516, 464519, 464523, 464526, 464528, 464532, 464563, 464568, 464570, 464590, 705011, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705576, 705584, 705622, 705628, 705702, 705706, 705711, 705713, 705728, 705751, 705753, 705795, 705812, 706007, 706098, 706215, 706321, 706350, 706372, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708261, 708473, 708494, 708504, 708528, 708534, 708546, 708549, 708585, 708589, 708595, 708629, 708652, 708657, 708721, 708722, 708723, 708749, 708750, 708752, 708770, 708774, 708775, 708776, 708780, 708797, 708798, 708802, 708815, 708819, 708820, 708831, 708832, 708841, 708843, 708844, 708848, 708851, 708853, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 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Distribution pattern

Worldwide

device · product 8 of 27

PROPONENT DR SL (Model L201)

Z-0086-2026
Recall number
Z-0086-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
2,426 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559044, Serial Numbers: 760356, 760366, 760367, 760404, 760409, 760412, 760441, 760443, 760500. GTIN 00802526576379, Serial numbers: 767280. GTIN 00802526559051, Serial numbers: 767088, 799586. GTIN 00802526576379, Serial Numbers: 100164, 100165, 100174, 100186, 100243, 100767, 100800, 723990, 724576, 724581, 724583, 724597, 724612, 724614, 724616, 724619, 724620, 724640, 724644, 724645, 724654, 724658, 724663, 724664, 724665, 724666, 724670, 724671, 724698, 724700, 724701, 724703, 724724, 724731, 724732, 724733, 724747, 724752, 724753, 724756, 724765, 724766, 724768, 724770, 724773, 724774, 724781, 724785, 724786, 724797, 724807, 724809, 724810, 724811, 724812, 724813, 724814, 724815, 724816, 724817, 724820, 724823, 724826, 724829, 724833, 724869, 724950, 724958, 724974, 724975, 724977, 724980, 724981, 725647, 725651, 725705, 725711, 725734, 725742, 725749, 725774, 725775, 725787, 726012, 726021, 726027, 726030, 726077, 726083, 726100, 726115, 726129, 726151, 726160, 726176, 726178, 726197, 726202, 726255, 726268, 726278, 726385, 726393, 726425, 726489, 726529, 726546, 726552, 726563, 726569, 726576, 726580, 726596, 726600, 726637, 726650, 726708, 726710, 726717, 726718, 726723, 726733, 726736, 726747, 726791, 726806, 726822, 727141, 727202, 733301, 734188, 735930, 736415, 736900, 737251, 737289, 737295, 737979, 737999, 738250, 738466, 738516, 738537, 738571, 738601, 738617, 738692, 738706, 739854, 739903, 739919, 739927, 739980, 740026, 740088, 740090, 740099, 743253, 743301, 743383, 743454, 743456, 744006, 744019, 744022, 744026, 744029, 744030, 744033, 744050, 744053, 744056, 744057, 744060, 744072, 744078, 744090, 746102, 746341, 746374, 753828, 753928, 753999, 754447, 754459, 758922, 759048, 759138, 759174, 759392, 759429, 759434, 759437, 759524, 759529, 760210, 761632, 762336, 762356, 762499, 762509, 762548, 762549, 764563, 765812, 765865, 766827, 766840, 767280, 767281, 767282, 767284, 767291, 767326, 767349, 767744, 767797, 767963, 768117, 768153, 768243, 768261, 768276, 768282, 768283, 768286, 768295, 768296, 768314, 768608, 768656, 768739, 768752, 768786, 768814, 768836, 768849, 768905, 768999, 771813, 771819, 779667, 779978, 779986, 779993, 779994, 780001, 780074, 780123, 780142, 780144, 780165, 780199, 780270, 780292, 780306, 780308, 780330, 780332, 780335, 780336, 780813, 780864, 780871, 780872, 797686, 797691, 797710, 797713, 797718. GTIN 00802526576874, Serial numbers: 715757, 715779, 715795, 715799, 715805, 715842, 715905, 715993, 716005, 716044, 716045, 716063, 716066, 716148, 716182, 716190, 716208, 716250, 716292, 716306, 716315, 716423, 716514, 716543, 716610, 716629, 716680, 716715, 716721, 716759, 716779, 716803, 717000, 717018, 717053, 717070, 717098, 717099, 717108, 717153, 717156, 717166, 717197, 717302, 717306, 717313, 717369, 717378, 717413, 717593, 717600, 717700, 717816, 717878, 717896, 717906, 717931, 717963, 717994, 717996, 718005, 718137, 718418, 718494, 718504, 718528, 718552, 718601, 718605, 718608, 718617, 718627, 718630, 718631, 718640, 718659, 718667, 718668, 718675, 718697, 718711, 718713, 718716, 718733, 718762, 718778, 718784, 718794, 718801, 718805, 718806, 718820, 718833, 718881, 718882, 718890, 718892, 718893, 718894, 718896, 718900, 718908, 718914, 718972, 718989, 719045, 724678, 724683, 724783, 724818, 725894, 725949, 736403, 737513, 737926, 737997, 738014, 738721, 738746, 738764, 738794, 738825, 738834, 738836, 739420, 739936, 740178, 740375, 741218, 741219, 741287, 741696, 741730, 741970, 742033, 742045, 742079, 742107, 742206, 742209, 742215, 742267, 742274, 742295, 742324, 742331, 742337, 742435, 742443, 742444, 742475, 742491, 742532, 742566, 742606, 742607, 742613, 742614, 742620, 742621, 742640, 742667, 742815, 742849, 742858, 742866, 742878, 742885, 742931, 742960, 742985, 743012, 743064, 743086, 743093, 743102, 743137, 743141, 743205, 743343, 743353, 743362, 743985, 743989, 744018, 744028, 744048, 744051, 744071, 744087, 745089, 745110, 745704, 745739, 745754, 745805, 745827, 745833, 745858, 745878, 745881, 745888, 745904, 745907, 745909, 745910, 745911, 745915, 745916, 745922, 745935, 745936, 745942, 745945, 745946, 745948, 745950, 745954, 745959, 745960, 745964, 745965, 745966, 745971, 745972, 745975, 745977, 745987, 746011, 746018, 746021, 746030, 746034, 746035, 746047, 746050, 746051, 746058, 746059, 746062, 746065, 746066, 746067, 746068, 746069, 746073, 746076, 746079, 746082, 746086, 746089, 746093, 746096, 746103, 746115, 746117, 746122, 746124, 746125, 746144, 746152, 746189, 746248, 746257, 746368, 746376, 746389, 750690, 751125, 751479, 752229, 752296, 752312, 752409, 752607, 752660, 752676, 752894, 752929, 753368, 753857, 754853, 754863, 754866, 754876, 754878, 754882, 754884, 754939, 754946, 754961, 760408, 760539, 760542, 760544, 760548, 760549, 760553, 760832, 760860, 760870, 760881, 760939, 761502, 761519, 761570, 763356, 763704, 763987, 764009, 764040, 764047, 764054, 764055, 764074, 764079, 764080, 764087, 764088, 764089, 764098, 764099, 764101, 764109, 764126, 764127, 764135, 764147, 764149, 764166, 764171, 764201, 764280, 764321, 764404, 764470, 766207, 766216, 781345, 781358, 781386, 781394, 781397, 781411, 781415, 781417, 781432, 781440, 781931, 781942, 782015, 782019, 782026, 782037, 782075, 782076, 782088, 782091, 782095, 782099, 782112, 782113, 782115, 782120, 782122, 782133, 782144, 782145, 782151, 782153, 782179, 782180, 782184, 782233, 782245, 782253, 782264, 782275, 782315, 782326, 782327, 782329, 782330, 782352, 782357, 782365, 782367, 782378, 782382, 782392, 782395, 782399, 782410, 782434, 782470, 782473, 782475, 782477, 782479, 782483, 782485, 782491, 782501, 782504, 782506, 782661, 782664, 782668, 782669, 782670, 782671. GTIN 00802526578014, Serial Numbers: 100140, 100181, 100221, 100282, 100287, 100290, 100401, 100407, 100410, 100707, 100750, 100763, 100766, 100770, 100772, 100781, 100782, 100783, 100785, 100786, 100788, 100793, 100803, 100804, 100808, 100818, 100827, 100838, 100839, 713123, 714640, 714796, 715611, 715802, 715831, 715847, 715854, 715886, 715907, 715912, 715934, 715949, 715953, 715981, 715986, 715991, 716002, 716007, 716011, 716016, 716028, 716054, 716081, 716093, 716097, 716106, 716107, 716108, 716147, 716162, 716163, 716171, 716183, 716194, 716205, 716228, 716237, 716239, 716247, 716255, 716256, 716260, 716267, 716282, 716288, 716289, 716290, 716291, 716309, 716317, 716333, 716342, 716346, 716360, 716375, 716380, 716396, 716407, 716410, 716419, 716421, 716424, 716426, 716433, 716435, 716443, 716455, 716473, 716545, 716572, 716605, 716641, 716727, 716750, 716760, 716769, 716836, 716839, 716841, 716845, 716868, 716990, 716994, 716997, 717009, 717034, 717040, 717077, 717083, 717118, 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Distribution pattern

Worldwide

device · product 9 of 27

Model Number L209 PROPONENT DR (VDD) SL Pacemaker

Z-0087-2026
Recall number
Z-0087-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
3146 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559068, Serial Numbers: 100002, 100006, 100007, 100008, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100017, 100019, 100020, 100021, 100022, 100023, 100025, 100026, 100027, 100028, 100029, 100030, 100031, 100032, 100034, 100035, 100036, 100037, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100121, 100123, 100124, 100125, 100126, 100127, 100128, 100129, 100130, 100131, 100132, 100133, 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GTIN 00802526576386, Serial Numbers: 700401, 700406, 700408, 700422, 700431, 700432, 700445, 700459, 700462, 700466, 700474, 700477, 700478, 700484, 700513, 700522, 700525, 700526, 700527, 700538, 700539, 700543, 700546, 700668, 700692, 700694, 700704, 700706, 700708, 700710, 700711, 700712, 700719, 700720, 700721, 700722, 700723, 700726, 700732, 700733, 700734, 700735, 700739, 700740, 700743, 700745, 700758, 700762, 700767, 700784, 700811, 700819, 700822, 700839, 700840, 700841, 700844, 700866, 700867, 700869, 700874, 700875, 700876, 700877, 700878, 700879, 700880, 700882, 700886, 700892, 700913, 700923, 700925, 700926, 700930, 700934, 700937, 700939, 700946, 700954, 700955, 700957, 700961, 700963, 700965, 700967, 700969, 700975, 700978, 700980, 700987, 700989, 700991, 700994, 700997, 700998, 701004, 701005, 701008, 701010, 701016, 701020, 701023, 701026, 701030, 701034, 701036, 701048, 701049, 701051, 701062, 701065, 701075, 701096, 701098, 701106, 701108, 701113, 701119, 701123, 701124, 701125, 701145, 701149, 701152, 701153, 701191, 701192, 701198, 701200, 701207, 701210, 701339, 701340, 701346, 701354, 701362, 701368, 701369, 701379, 701387, 701393, 701394, 701395, 701397, 701401, 701402, 701415, 701416, 701419, 701422, 701427, 701429, 701430, 701433, 701435, 701438, 701439, 701442, 701446, 701452, 701454, 701458, 701462, 701465, 701469, 701471, 701473, 701476, 701477, 701481, 701491, 701492, 701497, 701499, 701505, 701511, 701515, 701521, 701522, 701524, 701532, 701539, 701551, 701572, 701574, 701582, 701587, 701589, 701591, 701593, 701597, 701598, 701600, 701601, 701603, 701607, 701611, 701618, 701621, 701626, 701632, 701636, 701639, 701640, 701655, 701661, 701672, 701674, 701678, 701682, 701684, 701687, 701688, 701689, 701691, 701692, 701693, 701700, 701704, 701705, 701706, 701709, 701710, 701711, 701714, 701715, 701716, 701717, 701719, 701720, 701721, 701722, 701729, 701746, 701814, 701818, 701819, 701821, 701822, 701823, 701832, 701834, 701836, 701838, 701841, 701848, 701854, 701860, 701861, 701862, 701863, 701867, 701870, 701874, 701879, 701880, 701881, 701884, 701891, 701895, 701896, 701898, 701913, 701919, 701928, 701932, 701934, 701936, 701937, 701946, 701947, 701952, 701955, 701956, 701958, 701959, 701960, 701962, 701964, 701965, 701966, 701967, 701968, 701969, 701970, 701971, 701973, 701988, 701992, 701993, 701996, 702006, 702013, 702014, 702024, 702025, 702028, 702030, 702031, 702032, 702033, 702057, 702059, 702062, 702078, 702082, 702084, 702115, 702121, 702128, 702129, 702131, 702138, 702139, 702147, 702148, 702149, 702154, 702156, 702157, 702158, 702159, 702161, 702162, 702163, 702164, 702169, 702173, 702174, 702175, 702176, 702178, 702179, 702180, 702247, 702248, 702250, 702251, 702252, 702253, 702254, 702257, 702261, 702262, 702263, 702265, 702266, 702267, 702268, 702269, 702277, 702279, 702280, 702282, 702290, 702294, 702301, 702304, 702306, 702309, 702311, 702312, 702325, 702330, 702335, 702337, 702345, 702346, 702349, 702350, 702351, 702352, 702354, 702355, 702358, 702360, 702361, 702362, 702363, 702364, 702365, 702366, 702367, 702368, 702371, 702372, 702373, 702375, 702376, 702377, 702379, 702380, 702381, 702382, 702383, 702384, 702385, 702386, 702387, 702388, 702389, 702390, 702392, 702393, 702394, 702395, 702396, 702397, 702398, 702399, 702400, 702402, 702403, 702404, 702405, 702406, 702407, 702408, 702409, 702410, 702411, 702412, 702413, 702523, 702536, 702540, 702542, 702549, 702551, 702552, 702553, 702564, 702566, 702567, 702568, 702571, 702578, 702604, 702605, 702606, 702607, 702608, 702610, 702611, 702612, 702614, 702615, 702616, 702618, 702619, 702620, 702621, 702622, 702623, 702665, 702667, 702669, 702670, 702694, 702698, 702699, 702700, 702701, 702706, 702707, 702708, 702710, 702711, 702712, 702713, 702727, 702767, 702772, 702774, 702775, 702776, 702777, 702778, 702779, 702780, 702781, 702782, 702783, 702784, 702785, 702787, 702788, 702790, 702791, 702792, 702793, 702794, 702797, 702802, 702803, 702805, 702813, 702815, 702816, 702820, 702825, 702830, 702831, 702834, 702867, 702870, 702887, 702890, 702891, 702906, 702914, 702918, 702922, 702923, 702944, 702983, 703024, 703027, 703035, 703042, 703043, 703044, 703069, 703070, 703075, 703077, 703085, 703091, 703103, 703106, 703113, 703114, 703115, 703124, 703127, 703132, 703141, 703145, 703146, 703149, 703155, 703159.

Distribution pattern

Worldwide

device · product 10 of 27

Model Number L210 PROPONENT SR SL Pacemaker

Z-0088-2026
Recall number
Z-0088-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
41009 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559082, Serial Numbers: 100002, 100009, 100010, 100011, 100012, 100014, 100017, 100020, 100021, 100023, 100024, 100026, 100029, 100034, 100037, 100038, 100040, 100041, 100045, 100046, 100047, 100049, 100054, 100057, 100061, 100066, 100068, 100071, 100072, 100073, 100074, 100083, 100085, 100093, 100097, 100100, 100103, 100104, 100109, 100112, 100121, 100122, 100124, 100125, 100135, 100136, 100138, 100140, 100147, 100153, 100156, 100162, 100163, 100165, 100166, 100168, 100170, 100171, 100181, 100197, 100205, 100214, 100222, 100235, 100237, 100268, 100270, 100271, 100272, 100273, 100280, 100281, 100288, 100295, 100302, 100309, 100324, 100328, 100337, 100339, 100354, 100359, 100360, 100363, 100369, 100372, 100377, 100384, 100386, 100387, 100391, 100400, 100403, 100404, 100410, 100411, 100413, 100415, 100421, 100423, 100431, 100432, 100434, 100435, 100438, 100439, 100440, 100443, 100460, 100473, 100488, 100491, 100492, 100496, 100502, 100504, 100510, 100526, 100534, 100535, 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Distribution pattern

Worldwide

device · product 11 of 27

Model Number L211 PROPONENT DR SL MRI Pacemaker

Z-0089-2026
Recall number
Z-0089-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
106,536 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559105, Serial Numbers: 296409, 658411. GTIN 00802526576409, Serial Numbers: 431535. GTIN 00802526578038, Serial Numbers: 251896, 375153, 396268. 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Distribution pattern

Worldwide

device · product 12 of 27

Model Number L221 PROPONENT DR EL Pacemaker

Z-0090-2026
Recall number
Z-0090-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
3592 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526578045, Serial Numbers: 723080, 723248, 725570, 729255. GTIN 00802526559129. Serial Numbers: 732639. GTIN 00802526576416, Serial numbers: 100156, 100157, 100167, 100180, 100185, 100247, 100254, 100263, 100268, 100272, 100278, 100279, 100282, 100293, 100296, 100302, 100304, 100305, 100306, 100308, 100314, 100315, 100332, 100335, 100336, 100453, 702524, 702763, 703141, 703183, 703341, 703490, 704875, 705065, 705069, 706965, 707072, 707119, 707355, 707474, 707499, 707999, 708019, 708170, 708229, 709024, 712293, 712330, 712402, 712408, 712424, 712437, 712517, 713937, 714362, 714643, 714710, 714836, 714847, 715761, 715890, 716146, 716435, 716731, 717103, 717117, 717537, 718007, 718062, 718114, 718137, 718139, 718301, 718312, 719571, 719630, 719635, 719637, 719653, 719835, 720752, 720838, 721277, 721298, 721511, 721604, 722560, 723084, 723234, 723279, 723335, 723486, 723491, 723494, 723498, 723509, 723529, 723557, 723559, 723562, 723573, 723625, 724616, 724666, 724696, 724709, 724782, 724819, 724838, 724846, 724853, 724857, 724890, 724914, 725181, 725182, 725183, 725184, 725185, 725186, 725187, 725188, 725189, 725190, 725586, 725603, 725604, 725605, 725607, 725608, 725609, 725610, 725727, 725792, 725801, 726384, 726419, 726545, 726800, 726801, 726878, 727128, 727172, 727178, 727236, 727242, 727255, 727257, 727262, 727263, 727268, 727271, 727292, 727315, 727323, 727335, 727346, 727376, 727378, 727379, 727382, 728093, 728135, 728139, 728153, 728301, 728324, 728381, 728658, 728682, 728690, 728694, 728713, 728881, 728905, 728908, 728911, 728967, 728981, 728982, 729013, 729066, 729068, 729069, 729071, 729075, 729081, 729083, 729237, 729258, 729321, 729323, 729340, 729390, 729736, 730067, 730087, 730237, 730238, 730239, 731097, 731100, 731104, 731106, 731110, 731118, 731150, 731166, 731168, 731198, 731279, 731294, 731306, 733065, 733285, 733332, 733838, 734232, 734237, 734238, 734261, 735042. GTIN 00802526578045, Serial Numbers: 100200, 100307, 100313, 100316, 100327, 100329, 702672, 702711, 702810, 702921, 703010, 703011, 703012, 703080, 703124, 703130, 703143, 703149, 703156, 703177, 703180, 703184, 703185, 703189, 703195, 703204, 703228, 703230, 703234, 703235, 703243, 703244, 703252, 703256, 703257, 703265, 703267, 703268, 703270, 703272, 703273, 703279, 703283, 703284, 703288, 703296, 703297, 703298, 703299, 703300, 703303, 703307, 703311, 703312, 703313, 703315, 703322, 703323, 703329, 703439, 703485, 703487, 703488, 704720, 704832, 704879, 704883, 704911, 704935, 704939, 704943, 704957, 704963, 704993, 705071, 705073, 705074, 705207, 705209, 705240, 705639, 706096, 706447, 706517, 706548, 706554, 706562, 706568, 706577, 706579, 706616, 706647, 706682, 706684, 706734, 706765, 706766, 706824, 706846, 706858, 706891, 706912, 706913, 706920, 706923, 706926, 706936, 706946, 706956, 706991, 707016, 707043, 707101, 707111, 707115, 707116, 707117, 707138, 707144, 707149, 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Distribution pattern

Worldwide

device · product 13 of 27

Model Number L231, PROPONENT DR EL MRI Pacemaker

Z-0091-2026
Recall number
Z-0091-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
63,851 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559143, Serial Numbers: 756161, 799038, 841168. GTIN 00802526576423, Serial Numbers: 532638, 880141, 973836. GTIN 00802526578052, Serial Numbers: 594082, 727921, 812172, 832267, 899037, 944246, 978524. GTIN 00802526559143, Serial Numbers: 100008, 100026, 100030, 100038, 100045, 100046, 100052, 100053, 100059, 100061, 100066, 100077, 100078, 100079, 100081, 100083, 100087, 100088, 100099, 100104, 100105, 100108, 100114, 100126, 100130, 100134, 100136, 100142, 100148, 100151, 100153, 100154, 100156, 100161, 100162, 100163, 100164, 100165, 100168, 100172, 100175, 100178, 100180, 100181, 100187, 100188, 100190, 100191, 100193, 100196, 100199, 100201, 100203, 100205, 100206, 100207, 100208, 100210, 100212, 100213, 100216, 100218, 100220, 100235, 100236, 100243, 100244, 100245, 100246, 100247, 100251, 100252, 100253, 100254, 100256, 100261, 100265, 100275, 100279, 100280, 100282, 100283, 100288, 100289, 100292, 100293, 100294, 100296, 100299, 100300, 100302, 100305, 100306, 100307, 100308, 100309, 100310, 100314, 100316, 100317, 100318, 100322, 100326, 100327, 100328, 100329, 100333, 100335, 100339, 100340, 100341, 100342, 100345, 100348, 100350, 100352, 100358, 100361, 100364, 100365, 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Distribution pattern

Worldwide

device · product 14 of 27

Model Number L100, ESSENTIO SR SL Pacemaker

Z-0092-2026
Recall number
Z-0092-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
4827 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559150, Serial Numbers: 464853, 464855, 464865, 464866, 464867, 464868, 464871, 464872, 464874, 464879, 464881, 464882, 464886, 464896, 464907, 464911, 464912, 464913, 464914, 464915, 464916, 464917, 464919, 464921, 464922, 464925, 464927, 464929, 464930, 464935, 464937, 464938, 464939, 464940, 464941, 464947, 464948, 464955, 464956, 464957, 464960, 464962, 464966, 464967, 464970, 464971, 464972, 464977, 464978, 464979, 464980, 464982, 464983, 464988, 464991, 464997, 464998, 464999, 465004, 465005, 465006, 465007, 465009, 465011, 465012, 465014, 465015, 465019, 465025, 465026, 465027, 465029, 465032, 465037, 465038, 465041, 465043, 465044, 465046, 465049, 465050, 465053, 465054, 465055, 465056, 465057, 465060, 465061, 465062, 465063, 465064, 465065, 465067, 465069, 465070, 465072, 465075, 465076, 465078, 465079, 465081, 465084, 465085, 465088, 465089, 465092, 465093, 465097, 465102, 465103, 465104, 465105, 465106, 465113, 465116, 465123, 465126, 465128, 465132, 465133, 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Distribution pattern

Worldwide

device · product 15 of 27

Model Number L101, ESSENTIO DR SL Pacemaker

Z-0093-2026
Recall number
Z-0093-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
22,714 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559174, Serial Numbers: 100547, 100752, 100822, 100843, 100852, 100853, 100857, 100863, 100865, 100866, 100868, 100871, 100874, 100879, 100883, 100884, 100889, 100891, 100892, 100893, 100897, 100900, 100914, 100915, 100916, 100919, 100923, 100925, 100927, 100928, 100931, 100932, 100938, 100941, 100942, 100944, 100948, 100949, 100952, 100955, 100956, 100957, 100962, 100969, 100970, 100972, 100973, 100980, 100981, 100982, 100985, 100986, 100988, 100989, 100990, 100991, 100993, 100995, 100996, 101000, 101002, 101003, 101004, 101006, 101012, 101014, 101015, 101016, 101017, 101020, 101021, 101022, 101024, 101025, 101033, 101036, 101037, 101042, 101044, 101048, 101050, 101052, 101053, 101059, 101061, 101063, 101067, 101073, 101074, 101075, 101076, 101087, 101090, 101092, 101093, 101096, 101097, 101098, 101105, 101106, 101108, 101109, 101110, 101111, 101113, 101120, 101125, 101126, 101127, 101129, 101130, 101131, 101132, 101136, 101138, 101141, 101144, 101148, 101149, 101154, 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Distribution pattern

Worldwide

device · product 16 of 27

Model Number L110, ESSENTIO SR SL MRI Pacemaker

Z-0094-2026
Recall number
Z-0094-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
61,700 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559204, Serial Numbers: 102163, 700197, 700207, 701035, 701546, 702086, 702129, 702195, 702303, 702316, 702343, 702530, 702612, 702615, 702619, 702715, 702745, 702802, 702807, 702833, 702840, 702844, 702871, 702872, 702890, 702891, 702898, 702912, 702918, 702925, 702930, 702931, 702966, 702974, 702979, 702991, 702999, 703010, 703035, 703047, 703053, 703058, 703065, 703069, 703090, 703099, 703101, 703122, 703124, 703136, 703142, 703147, 703150, 703152, 703173, 703177, 703191, 703199, 703240, 703241, 703247, 703252, 703261, 703297, 703306, 703326, 703339, 703348, 703353, 703376, 703380, 703417, 703420, 703450, 703452, 703453, 703460, 703510, 703511, 703535, 704093, 704200, 704263, 704341, 704480, 704580, 704656, 704661, 704678, 704679, 704703, 704726, 704755, 704769, 704802, 704812, 704813, 704815, 704817, 704820, 704823, 704839, 704849, 704869, 704872, 704875, 704895, 704898, 704900, 704915, 704926, 704938, 704945, 704956, 704986, 704998, 705007, 705010, 705020, 705038, 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Distribution pattern

Worldwide

device · product 17 of 27

Model Number L111, ESSENTIO DR SL MRI Pacemaker

Z-0095-2026
Recall number
Z-0095-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
223,163 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131, 203086, 204240, 204255, 204383, 204472, 204532, 204553, 204558, 204581, 204619, 204644, 204658, 204672, 204680, 204704, 204729, 204735, 204748, 204768, 204779, 204855, 204883, 204891, 204907, 204916, 204929, 204934, 204947, 204951, 204957, 204959, 204968, 204985, 205002, 205044, 205073, 205083, 205105, 205130, 205149, 205192, 205199, 205211, 205227, 205233, 205236, 205290, 205360, 205362, 205363, 205408, 205412, 205413, 205415, 205455, 205480, 205543, 205553, 205560, 205585, 205586, 205587, 205625, 205632, 205636, 205672, 205673, 205686, 205688, 205733, 205742, 205767, 205770, 205773, 205782, 205791, 205796, 205797, 205810, 205854, 205855, 205857, 205861, 205863, 205907, 205911, 205920, 205940, 205945, 205946, 205958, 205961, 205965, 205967, 205971, 205975, 205977, 205979, 205989, 205992, 205997, 205998, 206011, 206019, 206033, 206045, 206046, 206049, 206069, 206070, 206074, 206075, 206080, 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Distribution pattern

Worldwide

device · product 18 of 27

Model Number L121 ESSENTIO DR EL Pacemaker

Z-0096-2026
Recall number
Z-0096-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
10,833 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559242, Serial Numbers: 100009, 100026, 100029, 100030, 100031, 100042, 100189, 100192, 100207, 100290, 100309, 100310, 100311, 100312, 100317, 100320, 100322, 100324, 100328, 100331, 100333, 100334, 100362, 100368, 100375, 100377, 100382, 100383, 100385, 100386, 100394, 100397, 100399, 100400, 100402, 100404, 100406, 100407, 100408, 100410, 100411, 100412, 100413, 100414, 100415, 100417, 100420, 100423, 100424, 100425, 100428, 100429, 100430, 100431, 100433, 100435, 100438, 100440, 100444, 100445, 100448, 100449, 100450, 100454, 100456, 100457, 100458, 100459, 100461, 100462, 100463, 100464, 100466, 100470, 100474, 100480, 100491, 100492, 100495, 100497, 100498, 100500, 100501, 100503, 100506, 100510, 100513, 100515, 100521, 100522, 100525, 100527, 100530, 100534, 100535, 100537, 100538, 100541, 100542, 100554, 100555, 100556, 100558, 100559, 100560, 100561, 100562, 100563, 100567, 100570, 100571, 100582, 100590, 100594, 100596, 100599, 100604, 100605, 100606, 100607, 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Distribution pattern

Worldwide

device · product 19 of 27

Model Number L131, ESSENTIO DR EL MRI Pacemaker

Z-0097-2026
Recall number
Z-0097-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
190,088 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559266, Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124, 102129, 102145, 102146, 102149, 102157, 102175, 102176, 102181, 102187, 102188, 102189, 102191, 102194, 102195, 102196, 102197, 102198, 102202, 102203, 102205, 102206, 102207, 102208, 102211, 102212, 102213, 102215, 102218, 102221, 102223, 102226, 102227, 102228, 102235, 102240, 102241, 102244, 102250, 102253, 102258, 102259, 102262, 102268, 102270, 102271, 102275, 102281, 102282, 102283, 102284, 102285, 102286, 102288, 102289, 102294, 102304, 102308, 102310, 102312, 102318, 102319, 102320, 102321, 102322, 102328, 102330, 102331, 102332, 102334, 102336, 102338, 102339, 102341, 102342, 102345, 102348, 102352, 102359, 102360, 102365, 102366, 102369, 102372, 102376, 102377, 102381, 102382, 102383, 102384, 102387, 102388, 102390, 102395, 102397, 102398, 102399, 102403, 102404, 102405, 102407, 102408, 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Distribution pattern

Worldwide

device · product 20 of 27

Model Number S701 ALTRUA 2 SR SL Pacemaker

Z-0098-2026
Recall number
Z-0098-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
4841 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526576492, Serial numbers: 705372. GTIN 00802526559334. 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Distribution pattern

Worldwide

device · product 21 of 27

Model Number S702, ALTRUA 2 DR SL Pacemaker

Z-0099-2026
Recall number
Z-0099-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
4055 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559358, Serial numbers: 100002, 100003, 100004, 100005, 100006, 100007, 100008, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100020, 100021, 100025, 100026, 100028, 100029, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100040, 100042, 100045, 100046, 100050, 100051, 100052, 100053, 100054, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100109, 100110, 100112, 100113, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123, 100125, 100126, 100128, 100130, 100132, 100133, 100134, 100135, 100136, 100137, 100138, 100139, 100140, 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GTIN 00802526576508, Serial Numbers: 100385, 100419, 100483, 100502, 100508, 100537, 100542, 100547, 100584, 100629, 100714, 100716, 100734, 100761, 100798, 700003, 700008, 700010, 700012, 700015, 700016, 700017, 700019, 700021, 700022, 700023, 700024, 700031, 700032, 700034, 700035, 700036, 700041, 700043, 700045, 700047, 700048, 700049, 700051, 700052, 700054, 700055, 700057, 700061, 700062, 700064, 700066, 700070, 700072, 700085, 700090, 700093, 700094, 700098, 700106, 700112, 700119, 700120, 700121, 700125, 700126, 700131, 700132, 700133, 700139, 700143, 700144, 700148, 700150, 700155, 700157, 700163, 700186, 700189, 700191, 700217, 700357, 700365, 700369, 700385, 700551, 700605, 700623, 700651, 700659, 700663, 700756, 701302, 701339, 701345, 701369, 701442, 701601, 701626, 701637, 701715, 701758, 701776, 701781, 701816, 701846, 701861, 701884, 701885, 701886, 701890, 701892, 701893, 701897, 701912, 701926, 701951, 701959, 701962, 702022, 702411, 702437, 702529, 702758, 702822, 702828, 702830, 702913, 703096, 703101, 703103, 703105, 703248, 703263, 703269, 703276, 703288, 703295, 703303, 703311, 703325, 703329, 703337, 703344, 703350, 703353, 703357, 703361, 703369, 703372, 703376, 703380, 703383, 703402, 703415, 703416, 703425, 703429, 703430, 703433, 703447, 703456, 703484, 703517, 703540, 703553, 703588, 704104, 704178, 704180, 704186, 704192, 704198, 704210, 704215, 704216, 704218, 704221, 704227, 704245, 704247, 704448, 704490, 704493, 704496, 704499, 704507, 704513, 704514, 704517, 704518, 704519, 704521, 704535, 704549, 704557, 704588, 704603, 704606, 706920, 706930, 706932, 706935, 706936, 706937, 706938, 706940, 706949, 707006, 707012, 707014, 707015, 708020, 708027, 708033, 708037, 708038, 708052, 709683, 709695, 709713, 709723, 709733, 709734, 709736, 709737, 709741, 709852, 709977, 710385, 710412, 710422, 710423, 710425, 710426, 710428, 710430, 710435, 710439, 710445, 710456, 710458, 710460, 710480, 710494, 710498, 710502, 710509, 710513, 710531, 710544, 710614, 710616, 710632, 710640, 710645, 710728, 710783, 710949, 711048, 711058, 711082, 711112, 711149, 711462, 711463, 711464, 711466, 711468, 711470, 711474, 711476, 711478, 711479, 711481. GTIN 00802526577000, Serial Numbers: 100827, 100834, 100840, 100868, 100880, 100888, 100890, 100896, 100900, 100904, 100905, 100908, 100925, 100926, 100927, 100928, 100930, 100931, 100933, 100935, 100936, 100939, 100940, 100944, 700207, 700211, 700229, 700243, 700249, 700257, 700259, 700263, 700264, 700266, 700271, 700272, 700275, 700291, 700296, 700297, 700302, 700304, 700312, 700322, 700326, 700329, 700333, 700378, 700435, 700503, 700586, 700745, 701099, 701127, 701290, 701380, 701384, 701390, 701413, 701423, 701503, 701504, 701506, 701679, 701680, 701682, 701683, 701684, 701685, 701686, 701687, 701688, 701689, 701690, 701691, 701695, 701696, 701964, 701965, 701968, 701974, 702064, 702065, 702066, 702069, 702071, 702072, 702073, 702074, 702075, 702079, 702082, 702086, 702087, 702089, 702090, 702093, 702095, 702097, 702099, 702100, 702102, 702103, 702104, 702105, 702107, 702108, 702109, 702110, 702111, 702128, 702131, 702133, 702134, 702135, 702136, 702139, 702140, 702144, 702145, 702148, 702150, 702152, 702161, 702174, 702175, 702176, 702177, 702180, 702185, 702186, 702235, 702270, 702288, 702302, 702305, 702306, 702307, 702310, 702353, 702354, 702355, 702363, 702367, 702368, 702370, 702371, 702375, 702401, 702402, 702404, 702421, 702426, 702448, 702449, 702450, 702451, 702456, 702460, 702512, 702514, 702516, 702518, 702519, 702520, 702521, 702522, 702524, 702528, 702537, 702539, 702572, 702573, 702574, 702575, 702577, 702578, 702581, 702582, 702583, 702584, 702585, 702588, 702589, 702657, 702660, 702705, 702735, 702783, 702784, 702785, 702787, 702799, 702825, 702888, 702889, 702945, 702946, 702949, 702950, 702951, 702961, 702962, 702963, 702966, 702967, 702968, 702975, 702982, 702985, 702996, 702999, 703000, 703033, 703045, 703064, 703066, 703067, 703093, 703097, 703099, 703107, 703113, 703114, 703115, 703116, 703117, 703118, 703121, 703141, 703170, 703173, 703175, 703179, 703181, 703342, 703343, 703354, 703355, 703356, 703360, 703392, 703393, 703394, 703395, 703396, 703397, 703398, 703399, 703400, 703403, 703407, 703408, 703409, 703437, 703464, 703472, 703473, 703474, 703475, 703476, 703477, 703478, 703479, 703480, 703481, 703482, 703485, 703486, 703487, 703489, 703490, 703491, 703493, 703496, 703562, 703566, 703567, 703569, 703571. GTIN 00802526578106, Serial Numbers: 100573, 100680, 100849, 100850, 100858, 100860, 100865, 100875, 100911, 700323, 700444, 700446, 700484, 700496, 700546, 700624, 700627, 700670, 700673, 700696, 700726, 700781, 700791, 700799, 700823, 700906, 701021, 701031, 701063, 701075, 701077, 701078, 701102, 701108, 701111, 701115, 701117, 701121, 701126, 701128, 701129, 701130, 701131, 701132, 701136, 701138, 701144, 701146, 701154, 701155, 701156, 701161, 701163, 701165, 701166, 701167, 701173, 701175, 701182, 701193, 701198, 701199, 701200, 701201, 701202, 701206, 701207, 701208, 701209, 701210, 701211, 701213, 701214, 701215, 701216, 701221, 701223, 701226, 701227, 701228, 701229, 701230, 701231, 701232, 701233, 701234, 701235, 701237, 701240, 701241, 701244, 701248, 701249, 701252, 701256, 701260, 701264, 701269, 701270, 701271, 701272, 701273, 701274, 701278, 701279, 701283, 701284, 701286, 701287, 701289, 701292, 701294, 701297, 701298, 701299, 701300, 701306, 701311, 701314, 701317, 701318, 701319, 701321, 701322, 701326, 701331, 701332, 701337, 701342, 701344, 701346, 701350, 701352, 701353, 701355, 701356, 701358, 701360, 701361, 701368, 701370, 701372, 701378, 701379, 701383, 701385, 701387, 701388, 701389, 701393, 701394, 701395, 701396, 701397, 701398, 701399, 701402, 701403, 701404, 701446, 701468, 701471, 701522, 701591, 701638, 701646, 701652, 701667, 701675, 701681, 701694, 701697, 701699, 701701, 701704, 701705, 701707, 701708, 701709, 701710, 701713, 701717, 701719, 701720, 701722, 701775, 701789, 701794, 701804, 701814, 701818, 701821, 701825, 701826, 701834, 701835, 701848, 701851, 701854, 701857, 701860, 701869, 701881, 701883, 701894, 701895, 701898, 701901, 701902, 701905, 701906, 701919, 701922, 701923, 701927, 701932, 701933, 701934, 701935, 701936, 701938, 701941, 701945, 701947, 701954, 701956, 701957, 701960, 701961, 701973, 701983, 701987, 701988, 701994, 702000, 702006, 702007, 702017, 702024, 702028, 702045, 702054, 702067, 702068, 702070, 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703196, 703198, 703200, 703201, 703203, 703205, 703213, 703216, 703218, 703220, 703224, 703227, 703228, 703243, 703244, 703245, 703249, 703250, 703252, 703253, 703254, 703259, 703265, 703271, 703272, 703280, 703285, 703289, 703293, 703294, 703296, 703306, 703307, 703314, 703315, 703318, 703322, 703327, 703331, 703753, 703919, 703949, 703973, 703974, 703976, 703977, 703978, 703993, 703994, 703995, 703996, 703997, 703998, 703999, 704000, 704002, 704003, 704004, 704005, 704006, 704007, 704009, 704010, 704014, 704015, 704016, 704017, 704018, 704020, 704021, 704022, 704023, 704025, 704026, 704028, 704030, 704031, 704033, 704036, 704042, 704043, 704045, 704046, 704047, 704049, 704050, 704051, 704057, 704080, 704082, 704085, 704086, 704102, 704103, 704105, 704109, 704111, 704112, 704119, 704401, 704404, 704441, 704450, 704460, 704462, 704464, 704465, 704468, 704484, 704492, 704494, 704501, 704512, 704523, 704524, 704526, 704534, 704544, 704551, 704576, 704587, 704591, 704592, 704593, 704595, 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706133, 706135, 706138, 706142, 706144, 706149, 706172, 706683, 706684, 706686. GTIN 00802526593208, Serial numbers: 701730, 701731, 701732, 70

Distribution pattern

Worldwide

device · product 22 of 27

Model Number S722, ALTRUA 2 DR EL Pacemaker

Z-0100-2026
Recall number
Z-0100-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
3376 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559372, Serial numbers: 100037, 100039, 100040, 100041, 100042, 100052, 100066, 100067, 100068, 100070, 100071, 100072, 100073, 100075, 100076, 100077, 100080, 100081, 700442, 700445, 700447, 700448, 700452, 700455, 700470, 700486, 700541, 700554, 700568, 700569, 700589, 700636, 700666, 702537, 702548, 702681, 702731, 702760, 702763, 702766, 702767, 702773, 702775, 702900, 702902, 702903, 702911, 702930, 704458, 704459, 704521, 707526, 707529, 708164, 708180, 708183, 708252, 708264, 708427. GTIN 00802526576515, Serial numbers: 100002, 100003, 100004, 100006, 100008, 100009, 100010, 100011, 100012, 100014, 100015, 100016, 100017, 100018, 100019, 100020, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100029, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100038, 100044, 100046, 100047, 100048, 100049, 100050, 100053, 100054, 100055, 100056, 100057, 100059, 100060, 100061, 100064, 100078, 100082, 100083, 100084, 100086, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700008, 700009, 700011, 700012, 700013, 700014, 700016, 700017, 700018, 700019, 700020, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700041, 700042, 700043, 700044, 700045, 700046, 700047, 700048, 700049, 700050, 700052, 700053, 700054, 700055, 700056, 700057, 700058, 700059, 700060, 700061, 700062, 700063, 700064, 700065, 700066, 700067, 700068, 700069, 700070, 700071, 700072, 700073, 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GTIN 00802526578113, Serial numbers: 700133, 700155, 700201, 700207, 700210, 700211, 700216, 700226, 700229, 700236, 700238, 700240, 700246, 700255, 700258, 700278, 700281, 700286, 700287, 700300, 700311, 700317, 700320, 700323, 700324, 700325, 700326, 700327, 700328, 700329, 700330, 700331, 700332, 700333, 700334, 700335, 700411, 700414, 700415, 700417, 700421, 700422, 700423, 700424, 700425, 700427, 700429, 700432, 700433, 700435, 700438, 700440, 700444, 700449, 700451, 700456, 700467, 700468, 700483, 700484, 700493, 700508, 700538, 700549, 700622, 700661, 700664, 700679, 700721, 700724, 700731, 700781, 700782, 700789, 700793, 700799, 700806, 700810, 700816, 700825, 700830, 700835, 700841, 700844, 700853, 700856, 700857, 700880, 701041, 701046, 701079, 701082, 701103, 701109, 701115, 701118, 701119, 701121, 701124, 701129, 701131, 701133, 701134, 701136, 701139, 701140, 701141, 701142, 701146, 701148, 701151, 701154, 701158, 701159, 701162, 701164, 701165, 701169, 701170, 701171, 701175, 701176, 701178, 701183, 701195, 701205, 701214, 701215, 701222, 701234, 701238, 701241, 701246, 701249, 701250, 701252, 701253, 701254, 701256, 701258, 701262, 701264, 701266, 701268, 701269, 701270, 701271, 701273, 701275, 701279, 701280, 701287, 701290, 701292, 701296, 701300, 701312, 701313, 701314, 701315, 701316, 701317, 701318, 701319, 701321, 701326, 701327, 701329, 701330, 701331, 701333, 701335, 701336, 701337, 701338, 701341, 701342, 701343, 701344, 701345, 701346, 701347, 701348, 701349, 701350, 701351, 701352, 701353, 701354, 701355, 701356, 701357, 701358, 701359, 701360, 701361, 701362, 701363, 701364, 701365, 701366, 701367, 701368, 701369, 701370, 701371, 701372, 701373, 701374, 701375, 701376, 701377, 701378, 701379, 701380, 701381, 701439, 701449, 701455, 701463, 701492, 701499, 701507, 701510, 701524, 701533, 701534, 701535, 701536, 701537, 701538, 701539, 701540, 701541, 701545, 701546, 701548, 701550, 701552, 701553, 701555, 701556, 701557, 701559, 701562, 701563, 701565, 701566, 701567, 701568, 701569, 701570, 701573, 701574, 701576, 701577, 701578, 701581, 701684, 701687, 701691, 701695, 701701, 701720, 701721, 701730, 701734, 701740, 701742, 701744, 701748, 701749, 701756, 701759, 701762, 701763, 701765, 701771, 701772, 701773, 701774, 701775, 701776, 701779, 701782, 701783, 701785, 701786, 701787, 701789, 701791, 701792, 701794, 701795, 701796, 701797, 701798, 701799, 701800, 701802, 701803, 701807, 701811, 701812, 701815, 701816, 701820, 701821, 701846, 701869, 701880, 702043, 702044, 702045, 702053, 702062, 702065, 702066, 702076, 702084, 702086, 702087, 702093, 702094, 702100, 702109, 702112, 702113, 702117, 702119, 702126, 702128, 702141, 702145, 702147, 702149, 702163, 702180, 702184, 702185, 702189.

Distribution pattern

Worldwide

device · product 23 of 27

Model Number U125, VALITUDE CRT-P EL

Z-0101-2026
Recall number
Z-0101-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
3620 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559389, Serial numbers: 100095, 100182, 100194, 100221, 100236, 100239, 100242, 100243, 100247, 100254, 100258, 100259, 100263, 100270, 100285, 100287, 100292, 100298, 100301, 100302, 100307, 100310, 100315, 100323, 100331, 100333, 100339, 100342, 100343, 100348, 100349, 100350, 100357, 100358, 100359, 100360, 100362, 100366, 100367, 100371, 100372, 100375, 100378, 100386, 100390, 100392, 100394, 100396, 100397, 100401, 100402, 100403, 100406, 100409, 100412, 100413, 100418, 100419, 100420, 100423, 100429, 100430, 100432, 100435, 100438, 100448, 100452, 100453, 100455, 100456, 100458, 100462, 100466, 100467, 100472, 100473, 100475, 100476, 100480, 100481, 100482, 100485, 100486, 100489, 100492, 100493, 100495, 100496, 100497, 100498, 100499, 100500, 100502, 100505, 100510, 100514, 100518, 100526, 100529, 100532, 100533, 100536, 100537, 100539, 100540, 100541, 100544, 100546, 100548, 100549, 100552, 100560, 100566, 100570, 100572, 100573, 100575, 100576, 100578, 100582, 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Distribution pattern

Worldwide

device · product 24 of 27

Model Number U128, VALITUDE CRT-P EL MRI

Z-0102-2026
Recall number
Z-0102-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
28,911 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559402, Serial numbers: 100187, 100217, 100222, 100236, 100251, 100253, 100260, 100262, 100274, 100275, 100277, 100289, 100317, 100328, 100330, 100350, 100359, 100361, 100363, 100364, 100369, 100372, 100373, 100376, 100379, 100381, 100386, 100391, 100392, 100394, 100397, 100399, 100400, 100401, 100402, 100404, 100410, 100411, 100414, 100417, 100420, 100433, 100435, 100437, 100444, 100445, 100447, 100449, 100450, 100452, 100453, 100456, 100458, 100459, 100463, 100466, 100471, 100473, 100474, 100475, 100476, 100481, 100482, 100483, 100484, 100485, 100486, 100491, 100497, 100500, 100501, 100502, 100503, 100506, 100507, 100511, 100513, 100514, 100519, 100520, 100522, 100523, 100527, 100533, 100535, 100536, 100537, 100539, 100541, 100544, 100545, 100547, 100550, 100551, 100553, 100556, 100557, 100560, 100562, 100563, 100564, 100565, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100577, 100580, 100581, 100583, 100586, 100589, 100590, 100592, 100593, 100595, 100596, 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Distribution pattern

Worldwide

device · product 25 of 27

Model Number U225 VISIONIST CRT-P EL

Z-0103-2026
Recall number
Z-0103-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
12,326 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559426, Serial numbers: 709683, 709711, 709737, 709778, 709780, 709789, 709792, 709794, 709804, 709815, 709816, 709827, 709828, 709829, 709830, 709831, 709889, 709907, 709912, 709914, 709926, 709935, 709938, 709941, 709943, 709962, 709965, 709966, 709969, 709985, 710005, 710016, 710027, 710105, 710235, 710283, 710379, 710386, 710408, 710414, 710416, 710418, 710424, 710438, 710443, 710450, 710458, 710459, 710466, 710467, 710479, 710481, 710482, 710490, 710540, 710544, 710545, 710558, 710561, 710566, 710571, 710572, 710575, 710586, 710593, 710595, 710600, 710613, 710622, 710624, 711100, 711103, 711115, 711116, 711186, 711234, 711261, 711493, 711497, 711646, 711698, 711699, 711704, 711706, 711719, 711756, 711771, 711780, 711781, 711783, 711784, 711812, 711817, 711852, 711859, 711865, 711867, 711870, 711881, 711894, 711896, 711901, 711913, 711915, 711916, 711927, 711929, 711933, 711941, 711977, 711984, 712029, 712100, 712114, 712120, 712122, 712140, 712143, 712187, 712188, 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Distribution pattern

Worldwide

device · product 26 of 27

Model Number U226, VISIONIST CRT-P EL

Z-0104-2026
Recall number
Z-0104-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
1,050 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559457, Serial numbers: 700333, 700335, 700342, 700344, 700346, 700347, 700352, 700364, 700372, 700386, 700388, 700390, 700391, 700425, 700426, 700427, 700428, 700429, 700437, 700448, 700455, 700460, 700461, 700464, 700490, 700498, 700500, 700520, 700538, 700539, 700570, 700587, 700591, 700638, 700653, 700665, 700676, 700693, 700700, 700702, 700704, 700705, 700707, 700708, 700711, 700718, 700720, 700722, 700735, 700736, 700755, 700759, 700765, 700768, 700774, 700782, 700790, 700794, 700796, 700809, 700817, 700830, 700870, 700874, 700879, 700881, 700882, 700883, 700887, 700889, 700903, 700905, 700908, 700911, 700917, 700925, 700935, 700940, 700950, 700951, 700959, 700968, 700970, 700978, 700980, 700984, 700988, 700990, 700991, 700994, 700997, 701005, 701008, 701017, 701019, 701023, 701032, 701038, 701048, 701071, 701083, 701091, 701096, 701097, 701100, 701108, 701116, 701117, 701122, 701127, 701136, 701140, 701141, 701142, 701146, 701147, 701148, 701151, 701153, 701154, 701161, 701165, 701166, 701167, 701174, 701178, 701181, 701182, 701183, 701187, 701192, 701197, 701199, 701201, 701203, 701207, 701212, 701217, 701240, 701242, 701247, 701249, 701252, 701255, 701256, 701318, 701320, 701321, 701330, 701334, 701335, 701342, 701349, 701356, 701425, 701427, 701439, 701440, 701446, 701447, 701448, 701462, 701490, 701510, 701511, 701517, 701525, 701528, 701529, 701532, 701537, 701538, 701539, 701543, 701547, 701550, 701551, 701556, 701559, 701562, 701563, 701564, 701589, 701590, 701597, 701603, 701607, 701631, 701643, 701647, 701649, 701661, 701662, 701664, 701685, 701686, 701690, 701691, 701696, 701703, 701709, 701714, 701715, 701722, 701723, 701727, 701729, 701732, 701735, 701736, 701741, 701745, 701750, 701756, 701758, 701768, 701769, 701771, 701772, 701778, 701783, 701789, 701790, 701799, 701803, 701807, 701817, 701818, 701826, 701827, 700890, 700907, 700928, 700929, 700936. GTIN 00802526559464, Serial numbers: 100006, 100009, 100011, 100012, 100013, 100014, 100016, 100017, 100018, 100019, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100028, 100029, 100030, 100032, 100034, 100035, 100038, 100039, 100042, 100044, 100045, 100046, 100048, 100049, 100050, 100052, 100053, 100054, 100055, 100058, 100059, 100061, 100062, 100063, 100066, 100067, 100068, 100069, 100070, 100073, 100075, 100076, 100077, 100081, 100087, 100089, 100092, 100094, 100095, 100096, 100098, 100100, 100101, 100102, 100105, 100107, 100108, 100109, 100111, 100112, 100113, 100116, 100117, 100118, 100120, 100123, 100124, 100126, 100127, 100128, 100129, 100132, 100133, 100134, 100135, 100136, 700002, 700003, 700004, 700006, 700007, 700008, 700010, 700011, 700012, 700013, 700014, 700015, 700018, 700019, 700020, 700021, 700023, 700024, 700025, 700026, 700030, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700042, 700044, 700045, 700048, 700050, 700051, 700052, 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701170, 701173, 701175, 701177, 701179, 701186, 701188, 701193, 701195, 701200, 701202, 701204, 701206, 701210, 701211, 701213, 701216, 701221, 701222, 701225, 701228, 701229, 701231, 701232, 701236, 701261, 701262, 701264, 701265, 701266, 701267, 701268, 701270, 701275, 701277, 701278, 701279, 701280, 701283, 701284, 701287, 701288, 701291, 701292, 701294, 701296, 701297, 701299, 701300, 701301, 701304, 701305, 701307, 701308, 701310, 701315, 701329, 701333, 701340, 701347, 701351, 701359, 701361, 701363, 701364, 701367, 701374, 701375, 701376, 701387, 701389, 701395, 701402, 701404, 701405, 701407, 701409, 701410, 701411, 701413, 701416, 701422, 701428, 701430, 701431, 701432, 701436, 701444, 701454, 701456, 701460, 701464, 701466, 701469, 701471, 701483, 701497, 701500, 701501, 701502, 701504, 701506, 701507, 701509, 701512, 701513, 701514, 701515, 701518, 701522, 701524, 701527, 701533, 701540, 701541, 701544, 701546, 701548, 701549, 701553, 701557, 701565, 701566, 701567, 701569, 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GTIN 00802526577123, Serial numbers: 100074, 100085, 100106, 700079, 700109, 700110, 700123, 700219, 700222, 700232, 700266, 700278, 700279, 700282, 700290, 700300, 700302, 700305, 700310, 700323, 700325, 700366, 700458, 700503, 700543, 700608, 700651, 700662, 700688, 700692, 700694, 700764, 700798, 700805, 700810, 700833, 700837, 700839, 700840, 700848, 700852, 700854, 700856, 700857, 700863, 700867, 700896, 700898, 700934, 700955, 700995, 701095, 701103, 701205, 701208, 701209, 701282, 701285, 701289, 701293, 701302, 701314, 701420, 701426, 701434, 701474, 701487, 701493, 701498, 701499, 701503, 701508, 701520, 701526, 701531, 701535, 701558, 701560, 701573, 701574, 701606, 701625, 701640, 701672, 701682, 701687, 701713, 701720, 701728, 701744, 701755, 701808, 701823.

Distribution pattern

Worldwide

device · product 27 of 27

Model Number U228, VISIONIST CRT-P EL MRI

Z-0105-2026
Recall number
Z-0105-2026
Initiated
August 20, 2025
Classification
Class I
Status
Ongoing
Quantity
41,191 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

Code information

GTIN 00802526559471, Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 733290, 733427, 733464, 733475, 733541, 733672, 733700, 733703, 733748, 733749, 733755, 733756, 733773, 733776, 733778, 733791, 733792, 733794, 733797, 733799, 733800, 733801, 733804, 733805, 733807, 733808, 733811, 733812, 733815, 733818, 733819, 733820, 733824, 733829, 733830, 733832, 733833, 733834, 733841, 733842, 733843, 733846, 733851, 733852, 733853, 733854, 733859, 733861, 733862, 733864, 733876, 733880, 733881, 733883, 733887, 733888, 733895, 733896, 733897, 733898, 733899, 733904, 733907, 733908, 733909, 733916, 733925, 733926, 733927, 733928, 733931, 733934, 733935, 733936, 733939, 733944, 733960, 733976, 733980, 733982, 734809, 734811, 734812, 734822, 734824, 734837, 734844, 734870, 734880, 734884, 734899, 734902, 734939, 734944, 734955, 734960, 734967, 734977, 734982, 734991, 734992, 734997, 734998, 734999, 735005, 735006, 735013, 735015, 735024, 735028, 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762358, 762359, 762361, 762362, 762364, 762365, 762366, 762368, 762369, 762370, 762372, 762373, 762374, 762376, 762377, 762378, 762379, 762381, 762389, 762390, 762391, 762393, 762395, 762396, 762397, 762398, 762399, 762402, 762404, 762408, 762409, 762413, 762414, 762421, 762422, 762423, 762424, 762426, 762427, 762429, 762430, 762431, 762434, 762435, 762439, 762444, 762447, 762448, 762451, 762452, 762457, 762458, 762460, 762461, 762463, 762464, 762466, 762468, 762479, 762503, 762514, 762554, 762557, 762559, 762568, 762573, 762577, 762584, 762587, 762595, 762596, 762597, 762603, 762617, 762618, 76

Distribution pattern

Worldwide