Boston Scientific Guider Softip XF — Class II medical device recall Z-1582-2022
Ongoing recall by Boston Scientific Corporation, reported 2022-08-31. The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for th
| Recall number | Z-1582-2022 |
|---|---|
| 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 | 2022-08-09 |
| Classified | 2022-08-25 |
| Reported by FDA | 2022-08-31 |
| Countries outside the US | BR, DE, FR, GR, IT, KR, RU |
| Quantity | 184 devices |
| UPC / GTIN / UDI-DI | 08714729202486 |
| Lot numbers | 27339850, 29308869 |
| Model numbers | H965100440 |
| Expiration dates | 2021-05-18, 2025-04-27 |
Product
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Reason for recall
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
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-1582-2022. 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.