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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92785

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

Open FDA event record

Event summary

Timeline bucket
July 27, 2023
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

16 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 16

Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

Z-0009-2024
Recall number
Z-0009-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
4990 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729202462, Lot/Batch Numbers: 25651700, 25651701, 25651702, 25651703, 25651704, 25651705, 25651706, 25651708, 25651709, 25651710, 25651711, 25761340, 25761341, 25761342, 25761343, 25964544, 25964545, 25964546, 25964547, 26019585, 26019586, 26034354, 26034357, 26138841, 26138842, 26138844, 26338705, 26338706, 26338707, 26338708, 26411750, 26411751, 26411752, 26745645, 26745646, 26891497, 27269743, 27654465, 27696356, 27703700, 27809357, 27996305, 26019584, 28107548, 28158175, 26019587, 28502663, 28502664, 28502665, 28584619, 28737891, 28737892, 28737893, 28795036, 28886611, 28886612, 29112775, 29112777, 26138843, 26138845, 26338704, 26338709, 26498390, 26891295, 26891496, 27103345, 27762224, 27809358, 28091480, 28384635, 28502662, 28795035, 28795037

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 2 of 16

Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Z-0010-2024
Recall number
Z-0010-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
4426 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 0871472920247, Lot/Batch Numbers: 26034355, 26034358, 25761346, 26034356, 26034832, 26034833, 26277184, 26277185, 26599620, 26599621, 26599624, 26745648, 26745649, 26891296, 27081941, 27081942, 27081943, 27103346, 27645560, 27696357, 27754497, 27779955, 27780469, 27996306, 28049141, 28384636, 28384637, 28502666, 28502667, 28676577, 28676578, 28841172, 28841173, 28841174, 28841175, 28841176, 28910752, 28910754, 26277186, 26411753, 26599622, 26599623, 26745647, 26891297, 26891498, 27081944, 27081945, 28841177, 28955941

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 3 of 16

Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter

Z-0011-2024
Recall number
Z-0011-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
8475 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729202486, Lot/Batch Numbers: 25651714, 25651716, 26034835, 26034836, 26034839, 25651712, 25651713, 25651715, 25651717, 25651718, 25651719, 26034834, 26034837, 26034838, 26059640, 26059641, 26138712, 26338710, 26338711, 26338712, 26338713, 26338714, 26338715, 26599628, 26599629, 26599632, 26599633, 26745651, 26745652, 26745653, 26745654, 26745655, 26745656, 26891494, 26891499, 26891761, 26891762, 26891763, 26891764, 26891766, 26891767, 27081946, 27162090, 27162091, 27162092, 27184893, 27184895, 27192450, 27192451, 27347761, 27386636, 27516584, 27568838, 27568839, 27654466, 27661667, 27669282, 27728491, 27894535, 27943983, 28320869, 28320870, 28320871, 28320872, 28384638, 28384639, 28384660, 26599625, 28471411, 28502668, 28502669, 26599626, 28676785, 28676786, 28676787, 28676788, 29308869, 26599627, 29308874, 26599630, 26599631, 26745650, 26891492, 26891493, 26891495, 26891760, 26891765, 27081947, 27367346, 27367347, 27661666, 27669283, 27735227, 27735228, 27894534, 28471410, 28502670, 29308872

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 4 of 16

Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter

Z-0012-2024
Recall number
Z-0012-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
2245 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729202509, Lot/Batch Numbers: 26059397, 26338716, 25822912, 25822914, 25822915, 25822916, 26059642, 26584704, 26585219, 26745658, 26745659, 26891768, 27177893, 27412261, 27504202, 27568860, 27754498, 27816607, 28100259, 28384661, 28502671, 28737894, 28737895, 26745657, 27177892, 28320873, 28584618, 28795038

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 5 of 16

Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Z-0013-2024
Recall number
Z-0013-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
3783 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729202516, Lot/Batch Numbers: 25761345, 26059398, 26138707, 26599635, 26599636, 25761344, 25964138, 25964139, 25964480, 25964481, 25964482, 26059399, 26130252, 26130253, 26138708, 26277183, 26599634, 26599637, 26746100, 26746101, 26746102, 26746103, 26891769, 26891770, 26997421, 26997422, 27129310, 27129311, 27144692, 27779956, 27779958, 28384662, 28502672, 28676780, 28832480, 28832482, 28886617, 28886618, 28886619, 28955942, 27144691, 27269744, 27585414, 28007176, 28676579, 28886800

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 6 of 16

Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter

Z-0014-2024
Recall number
Z-0014-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
17436 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729202523, Lot/Batch Numbers: 25651745, 25651749, 25651755, 25761258, 25914835, 25915125, 25964541, 26138808, 26138818, 26138819, 26338718, 26339260, 26339261, 26498387, 26726579, 26726621, 26726622, 26726624, 26746104, 26746105, 25651740, 25651741, 25651742, 25651743, 25651744, 25651746, 25651747, 25651748, 25651750, 25651751, 25651752, 25761255, 25761256, 25761257, 25914833, 25914834, 25914836, 25915124, 25964498, 25964499, 25964540, 25964542, 25964543, 26059648, 26059651, 26059653, 26138719, 26138804, 26138811, 26138815, 26138816, 26138817, 26138840, 26338717, 26338719, 26339262, 26498388, 26498389, 26599638, 26599639, 26599700, 26599701, 26599702, 26599703, 26726620, 26726623, 27016491, 26726625, 27016624, 26746106, 26746107, 26746108, 26746109, 26891771, 26891772, 26891773, 27007548, 27007549, 27016490, 27042423, 27121007, 27121008, 27136897, 27136898, 27152183, 27203534, 27247812, 27262276, 27265388, 27265390, 27265391, 27265393, 27323834, 27327741, 27367348, 27367349, 27379023, 27420627, 27420628, 27431146, 27450919, 27504209, 27516636, 27558591, 27558592, 27558594, 27611878, 27619841, 27627222, 27627223, 27677022, 27247813, 27262277, 27696121, 27265392, 27703701, 27741721, 27747953, 27767764, 27327740, 27928346, 27936345, 27972713, 27972714, 28007177, 28239957, 27386633, 28242517, 28242518, 27386634, 28250417, 28260600, 28260601, 28267426, 27420629, 28275299, 28283283, 28283284, 28291109, 27450920, 28320860, 28320861, 28384663, 27459237, 28384665, 28471406, 28471407, 28471408, 28471409, 28502673, 28502674, 27558593, 27619799, 28632173, 28632175, 29146651, 27677023, 29146653, 29146654, 27687781, 29146656, 27687782, 29146658, 27696122, 29183520, 29183521, 29183524, 29233903, 29233906, 29233907, 29233909, 29233910, 29233911, 27741722, 29233913, 29271762, 27775275, 29271766, 29271770, 29418790, 27928345, 27936346, 27952564, 27961071, 28239958, 28250416, 28267427, 28275300, 28291108, 28320779, 28320862, 28384664, 28384666, 28502675, 28502676, 28502677, 28502678, 28584616, 28616010, 28632174, 29146650, 29146652, 29146655, 29146657, 29146659, 29183522, 29183523, 29233908, 29233912, 29271763, 29271764, 29418783, 29418789

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 7 of 16

Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter

Z-0015-2024
Recall number
Z-0015-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
1086 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729283508, Lot/Batch Numbers: 26277195, 26891778, 25715235, 25715236, 25761247, 25761248, 26059690, 26277194, 26599706, 27170548, 27444248, 27516585, 28057178, 28584686, 28595475, 28811944

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 8 of 16

Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter

Z-0016-2024
Recall number
Z-0016-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
326 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729283515, Lot/Batch Numbers: 25651754, 25651753, 25761245, 26059691, 26409982, 26599707, 27219434 ****recall letter has more lot numbers****

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 9 of 16

Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter

Z-0017-2024
Recall number
Z-0017-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
1728 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729244295, Lot/Batch Numbers: 26138711, 26276489, 26276490, 26590803, 26746110, 26891804, 26891805, 27162093, 27162094, 27203536, 27431372, 26059693, 26138710, 26276491, 26590802, 26746111, 27203537, 27219436, 27431373, 27526941, 27801040, 28811942, 28811943

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 10 of 16

Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter

Z-0018-2024
Recall number
Z-0018-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
1004 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729244301, Lot/Batch Numbers: 27241919, 27516638, 27780467, 27780470, 28065090, 26138318, 26891812, 28676781, 28595471, 28676782, 28886804, 28910751

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 11 of 16

Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter

Z-0019-2024
Recall number
Z-0019-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
2184 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729244318, Lot/Batch Numbers: 25823581, 26059696, 26130255, 26277192, 26746112, 26984240, 27241920, 25823580, 25964485, 25964486, 25964487, 26059694, 26130254, 26277190, 26277191, 26599708, 26599709, 26599710, 26599711, 26599712, 26746113, 26984241, 26984253, 27203538, 27203539, 27379022, 28384669, 28632346, 28632344

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 12 of 16

Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter

Z-0020-2024
Recall number
Z-0020-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
3738 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729244332, Lot/Batch Numbers: 26059697, 26339267, 26339269, 26590800, 26746116, 26891817, 26891818, 27065537, 27288435, 27535145, 27592321, 28132917, 28384670, 25715225, 25715226, 26059695, 26339266, 26339268, 26498391, 26590801, 26746114, 26746115, 26891816, 28632177, 27081948, 27254932, 27280217, 27435623, 27558595, 27592320, 27767765, 27824570, 28115146, 28738180, 28384671, 28632176, 28632178, 28632179, 28737899, 28738181, 28886805, 28886806, 28886807, 29113162, 28795500

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 13 of 16

Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter

Z-0021-2024
Recall number
Z-0021-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
828 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729244349, Lot/Batch Numbers: 26746117, 26891819, 27121009, 27435625, 26411755, 26746118, 27435626, 27444224, 27558596 ****letter has more lot numbers than spreadsheet*****

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 14 of 16

Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter

Z-0022-2024
Recall number
Z-0022-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
3777 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729244356, Lot/Batch Numbers: 26277188, 26599713, 26709826, 27170547, 27203658, 27339851, 27535146, 27728492, 27902047, 28320867, 28564218, 28616007, 28632345, 26138706, 26277189, 26411756, 26411757, 26599714, 26599715, 26709827, 26746119, 26746120, 26891840, 26891841, 26984254, 27254933, 27379026, 27379027, 27558597, 27645561, 27782880, 27980980, 27988374, 28320864, 28320865, 28320866, 28564219, 28564380, 28584613, 28616008, 28632340, 28632341, 28632342, 29513117

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 15 of 16

Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter

Z-0023-2024
Recall number
Z-0023-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
1170 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729283539, Lot/Batch Numbers: 26409983, 26590809, 27450921, 27780468, 25715223, 25761249, 25964483, 25964484, 26138315, 26409984, 26891844, 27558598, 27780463, 28632343, 28737896

Distribution pattern

US Nationwide distribution in the state of Indiana.

device · product 16 of 16

Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter

Z-0024-2024
Recall number
Z-0024-2024
Initiated
July 27, 2023
Classification
Class II
Status
Ongoing
Quantity
116 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

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Reason for recall

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

Code information

GTIN 08714729283546, Lot/Batch Numbers: 25715222, 27762225, 27780464

Distribution pattern

US Nationwide distribution in the state of Indiana.