Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE — Class II medical device recall Z-0014-2024
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-0014-2024 |
|---|---|
| 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 | 17,436 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08714729202523 |
| Lot numbers | 25651740, 25651741, 25651742, 25651743, 25651744, 25651745, 25651746, 25651747, 25651748, 25651749, 25651750, 25651751, 25651752, 25651755, 25761255, 25761256, 25761257, 25761258, 25914833, 25914834, 25914835, 25914836, 25915124, 25915125, 25964498, 25964499, 25964540, 25964541, 25964542, 25964543, 26059648, 26059651, 26059653, 26138719, 26138804, 26138808, 26138811, 26138815, 26138816, 26138817 and 173 more |
| Model numbers | H965100480 |
Product
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, 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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0014-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.