Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE — Class II medical device recall Z-0021-2024
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-0021-2024 |
|---|---|
| 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 | 828 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08714729244349 |
| Lot numbers | 26411755, 26746117, 26746118, 26891819, 27121009, 27435625, 27435626, 27444224, 27558596 |
| Model numbers | M003101470 |
Product
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, 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-0021-2024. 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.