Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM — Class II medical device recall Z-0011-2024
Ongoing recall by Boston Scientific Corporation, reported 2023-10-11, distributed nationwide. Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the in
| Recall number | Z-0011-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2023-07-27 |
| Classified | 2023-10-03 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| Quantity | 8,475 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08714729202486 |
| Lot numbers | 25651712, 25651713, 25651714, 25651715, 25651716, 25651717, 25651718, 25651719, 26034834, 26034835, 26034836, 26034837, 26034838, 26034839, 26059640, 26059641, 26138712, 26338710, 26338711, 26338712, 26338713, 26338714, 26338715, 26599625, 26599626, 26599627, 26599628, 26599629, 26599630, 26599631, 26599632, 26599633, 26745650, 26745651, 26745652, 26745653, 26745654, 26745655, 26745656, 26891492 and 58 more |
| Model numbers | H965100440 |
Product
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.