Lower risk Medical device recall · FDA · Published July 27, 2023
Boston Scientific Guider Softip Catheter Recall: Incorrect Tip Curve Shape
Boston Scientific recalls Guider Softip Guide Catheters with incorrect tip curve shape. Affected lots may not function as intended during cardiac procedures.
Lower-risk 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.
Contact the company
Recalling firmBoston Scientific Corporation1 Scimed Pl · Maple Grove, MN 55311-1565
What happened, in plain English
Boston Scientific is recalling certain Guider Softip Guide Catheters due to an incorrect tip curve shape that could affect medical procedures. This recall affects specific lots that may not function properly during cardiac catheterization. Read more at govinfonow.com/recall/57569-boston-scientific-guider-softip-catheter-recall-incorrect-tip-curve-shape.
Source Summary by GovInfoNow · govinfonow.com/recall/57569-boston-scientific-guider-softip-catheter-recall-incorrect-tip-curve-shape · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0024-2024
Cite this page
“Boston Scientific Guider Softip Catheter Recall: Incorrect Tip Curve Shape.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57569-boston-scientific-guider-softip-catheter-recall-incorrect-tip-curve-shape. Based on FDA recall #Z-0024-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0024-2024%22&limit=1).
Why it’s dangerous
The catheters have a tip curve shape that differs from what's labeled, which might cause improper positioning during cardiac procedures. This could lead to complications like vessel damage or inaccurate procedure outcomes.
Who’s affected
Cardiologists and medical professionals who use the recalled catheters for cardiac procedures are most at risk. Patients undergoing these procedures with the affected catheters could experience complications.
How to tell if you have this one
Check for the catalog number M003101630 and lot numbers 25715222, 27762225, or 27780464 on the catheter packaging or label.
- Brand
Boston Scientific- Product
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter- Category
Medical device
All 16 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the state of Indiana.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0009-2024 | Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter; 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 | 4990 units |
| Z-0010-2024 | Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter; 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 | 4426 units |
| Z-0011-2024 | Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter; 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 | 8475 units |
| Z-0012-2024 | Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter; 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 | 2245 units |
| Z-0013-2024 | Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter; 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 | 3783 units |
| Z-0014-2024 | Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter; 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 | 17436 units |
| Z-0015-2024 | Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter; GTIN 08714729283508, Lot/Batch Numbers: 26277195, 26891778, 25715235, 25715236, 25761247, 25761248, 26059690, 26277194, 26599706, 27170548, 27444248, 27516585, 28057178, 28584686, 28595475, 28811944 | 1086 units |
| Z-0016-2024 | Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter; GTIN 08714729283515, Lot/Batch Numbers: 25651754, 25651753, 25761245, 26059691, 26409982, 26599707, 27219434 ****recall letter has more lot numbers**** | 326 units |
| Z-0017-2024 | Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter; 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 | 1728 units |
| Z-0018-2024 | Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter; GTIN 08714729244301, Lot/Batch Numbers: 27241919, 27516638, 27780467, 27780470, 28065090, 26138318, 26891812, 28676781, 28595471, 28676782, 28886804, 28910751 | 1004 units |
| Z-0019-2024 | Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter; 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 | 2184 units |
| Z-0020-2024 | Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter; 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 | 3738 units |
| Z-0021-2024 | Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter; GTIN 08714729244349, Lot/Batch Numbers: 26746117, 26891819, 27121009, 27435625, 26411755, 26746118, 27435626, 27444224, 27558596 ****letter has more lot numbers than spreadsheet***** | 828 units |
| Z-0022-2024 | Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter; 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 | 3777 units |
| Z-0023-2024 | Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter; GTIN 08714729283539, Lot/Batch Numbers: 26409983, 26590809, 27450921, 27780468, 25715223, 25761249, 25964483, 25964484, 26138315, 26409984, 26891844, 27558598, 27780463, 28632343, 28737896 | 1170 units |
| Z-0024-2024 | Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter; GTIN 08714729283546, Lot/Batch Numbers: 25715222, 27762225, 27780464 | 116 units |
What to do — step by step
Check Product Details
Verify the catalog number and lot numbers on the catheter packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of Indiana.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0024-2024 (July 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0024-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.