Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96049

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

Open FDA event record

Event summary

Timeline bucket
December 20, 2024
Product types
Device
Classifications
Class II
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

14 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 14

AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640

Z-1024-2025
Recall number
Z-1024-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
495 units US; 2 units(OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729904588 Lot Numbers: 32891042, 32900457, 32908438, 33215358, 33215359, 33216060, 33216062, 33219660, 33219662, 33219663, 33315967, 33315970, 33324398, 33500190, 33520871, 33520872, 33537659, 33538481, 33538484, 33559005, 33813654, 33813655, 33871244, 33948086, 33996038, 33996039, 34004999, 34116469, 34116470, 34251352, 34251353, 34261614, 34261615, 34261616, 34263376, 34263377, 34277689, 34277690, 34297653, 34297657, 34512952, 34526862

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 2 of 14

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650

Z-1025-2025
Recall number
Z-1025-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
1144 units US; 60 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729904595 Lot Numbers: 32891503, 32946481, 32966087, 32976911, 32986912, 32986913, 32986914, 32996152, 33004776, 33004777, 33004779, 33008425, 33527176, 33547873, 33559652, 33562171, 33568700, 33568705, 33568709, 33580106, 33686169, 33686170, 33686171, 33686172, 33996104, 33996109, 34006713, 34052770, 34052771, 34052772, 34052773, 34065575, 34065576, 34065577, 34065578, 34136366, 33008426, 33008427, 33013790, 33013791, 33038652, 33158792, 33161956, 33219664, 33219665, 33223921, 33223922, 33223925, 33233417, 33233418, 33233419, 33233460, 33233461, 33235723, 33487216, 33487218, 33489572, 33527175, 33686173, 33686174, 33765268, 33765269, 33765271, 33765272, 33765273, 33765274, 33766684, 33775698, 33813656, 33813657, 33813658, 33813659, 33825083, 33825084, 33825087, 33825091, 33873459, 33873923, 33881493, 33996102, 34136369, 34136370, 34142870, 34142871, 34144414, 34144416, 34251354, 34261613, 34261617, 34261618, 34261619, 34263374, 34271464, 34271465, 34276937, 34276938, 34277681, 34286615, 34286616, 34286617, 34286618, 34308441

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 3 of 14

AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660

Z-1026-2025
Recall number
Z-1026-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
1399 units; 20 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729951179 Lot Numbers: 32913258, 32914587, 32914588, 32914951, 32919344, 33161778, 33167722, 33167723, 33167724, 33168696, 33168697, 33217106, 33217107, 33223926, 33223927, 33224949, 33233462, 33234152, 33235720, 33235721, 33242497, 33242560, 33324868, 33333642, 33577901, 33577905, 33661063, 33677043, 33677044, 33677045, 33677046, 33677047, 33677048, 33680523, 33697485, 33767880, 33776935, 33776936, 33778737, 33778738, 33785758, 33785759, 33787022, 33787023, 33787024, 33787025, 33796610, 33804642, 34034896, 34034897, 34034898, 34037953, 34037954, 34037955, 34038584, 34038795, 34047362, 34047364, 34047365, 34074520, 34074521, 34093768, 34093769, 34101923, 34101924, 34126523, 34126524, 34128158, 34130337, 34134859, 34135080, 34136360, 33333648, 33470460, 33488331, 33509930, 33509931, 33509936, 33509937, 33510694, 33510695, 33517861, 33517862, 33568702, 33568703, 33571498, 33577559, 33577900, 33827339, 33883094, 33899654, 33902104, 33902106, 33908817, 33908818, 33908819, 33930901, 33931714, 33939630, 33998884, 33998885, 34004996, 34006717, 34027241, 34142867, 34144887, 34161824, 34161826, 34165830, 34165831, 34172977, 34172979, 34262100, 34307464, 34344894, 34356855, 34364514, 34772813

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 4 of 14

AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670

Z-1027-2025
Recall number
Z-1027-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
309 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729979333 Lot Numbers: 32901294, 33223930, 33328461, 33413626, 33459702, 33686175, 33686176, 33766912, 33814306, 33825089, 33860266, 33920983, 33920984, 33930917, 34020982, 34020983, 34111459, 34111480, 34111481, 34135618, 34135619, 34136372, 34271635, 34297652, 34316296

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 5 of 14

AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680

Z-1028-2025
Recall number
Z-1028-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
31 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 00191506008086 Lot Numbers: 33457806, 33512838, 34035520

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 6 of 14

AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

Z-1029-2025
Recall number
Z-1029-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
47 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 00191506008093 Lot Numbers: 33419782, 33477824, 34116467, 33419783, 33511487

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 7 of 14

AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740

Z-1030-2025
Recall number
Z-1030-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729904625 Lot Numbers: 34477280

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 8 of 14

AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750

Z-1031-2025
Recall number
Z-1031-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
38 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729904632 Lot Numbers: 33740402, 33785754, 34037422

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 9 of 14

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520

Z-1032-2025
Recall number
Z-1032-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
263 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729904540 Lot Numbers: 33336402, 33336404, 33336405, 33336411, 33392916, 33392917, 33393302, 33411607, 33437479, 33548501, 33577903, 33704371, 33712822, 33986537, 34017087, 34017088, 34017089, 34028458, 34065579, 34065660, 34083271, 34083272

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 10 of 14

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530

Z-1033-2025
Recall number
Z-1033-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
91 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729904557 Lot Numbers: 33335139, 33335340, 33336413, 33511491, 34015885, 34065661, 34068983, 34101926

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 11 of 14

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

Z-1034-2025
Recall number
Z-1034-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
519 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729904564 Lot Numbers: 33169261, 33169263, 33209127, 33243075, 33243077, 33243856, 33255964, 33488328, 33787031, 33787032, 33853395, 33882221, 33882222, 33899656, 33909280, 33979053, 33979055, 34027245, 34027246, 34035523, 34035524, 34052776, 34052778, 34161831, 34161832, 34161833, 34161834, 34190943, 34190944, 34190945, 34192326, 34192327, 34201917, 34203537, 34203539, 34204795, 34223677, 34223679, 34226399, 34226540, 34243427, 34243428, 34375175, 34381803, 34585408, 34731098

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 12 of 14

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550

Z-1035-2025
Recall number
Z-1035-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
1530 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729904571 Lot Numbers: 32868212, 32947950, 32998424, 32998425, 33177074, 33177075, 33177077, 33185872, 33185873, 33185874, 33185875, 33185877, 33187647, 33187648, 33195395, 33195397, 33209120, 33209135, 33209138, 33209139, 33209840, 33243859, 33257462, 33257474, 33257477, 33268719, 33278543, 33284513, 33284514, 33284517, 33293229, 33301038, 33301039, 33301341, 33315855, 33315856, 33317299, 33318093, 33527177, 33537640, 33538743, 33577557, 33688060, 33688061, 33747542, 33747543, 33749929, 33749930, 33756082, 33756083, 33765265, 33765266, 33804645, 33805203, 33805205, 33805206, 33805208, 33893271, 33902105, 33933459, 33939639, 33948084, 33986699, 33987798, 33987799, 33988020, 33988021, 33988022, 33988779, 33989320, 34015887, 34028520, 34035525, 34035526, 34035529, 34035530, 34035965, 34044970, 34044971, 34044972, 34044973, 34047717, 34047718, 34047819, 34065662, 34065663, 34065664, 34065665, 34074525, 34074528, 34083208, 34085560, 34085561, 34086663, 34093771, 34095708, 34095710, 34095711, 34116466, 34126531, 34126534, 34126535, 34128862, 34135087, 34135090, 34161836, 34161837, 34161838, 34161839, 34163750, 34163751, 34172106, 34172107, 34180838, 34181501, 34182330, 34190948, 34201919, 34232994, 34232995, 34232997, 34334695, 34334696, 34335369, 34371098, 34372194, 34375171, 34375173, 34381805, 34512950

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 13 of 14

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560

Z-1036-2025
Recall number
Z-1036-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
1102 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729951100 Lot Numbers: 32865866, 32874910, 32875944, 32876867, 32876869, 32876870, 33195387, 33195388, 33195389, 33195390, 33209841, 33209843, 33215357, 33283337, 33284518, 33284519, 33288532, 33288534, 33301346, 33301347, 33301348, 33301351, 33301352, 33466658, 33467021, 33470461, 33470464, 33470465, 33486865, 33487939, 33519203, 33528652, 33581298, 33581681, 33601247, 33657824, 33686163, 33686166, 33765267, 33804643, 33806748, 33909812, 33909813, 33920980, 33948082, 33977789, 33981155, 33981156, 34006718, 34015882, 34020432, 34020433, 34020434, 34027240, 34047363, 34065574, 34074522, 34076577, 34083205, 34085563, 34101925, 34102569, 34102570, 34102571, 34103179, 34103340, 34111453, 34111454, 34111456, 34111845, 34116472, 34116473, 34126522, 34180835, 34190940, 34190949, 34201914, 34205933, 34205934, 34213826, 34214585, 34214586, 34223572, 34223574, 34325972, 34325974, 34334692, 34335366, 34371087, 34371088, 34371090, 34523681, 34545213, 34649321, 34815303

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided

device · product 14 of 14

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570

Z-1037-2025
Recall number
Z-1037-2025
Initiated
December 20, 2024
Classification
Class II
Status
Ongoing
Quantity
118 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Code information

GTIN: 08714729976684 Lot Numbers: 32878539, 33336847, 33338446, 33775901, 33795273, 33900261, 33900262, 34076575, 34083270, 34172108, 34172109

Distribution pattern

Nationwide including Puerto Rico Foreign: To be provided