Boston Scientific POLARSHEATH Steerable Sheath 12F — Class I medical device recall Z-1302-2024
Ongoing recall by Boston Scientific Corporation, reported 2024-04-03. Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the in
| Recall number | Z-1302-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2024-02-12 |
| Classified | 2024-03-26 |
| Reported by FDA | 2024-04-03 |
| Countries outside the US | AT, DE, EE, ES, FI, FR, GB, GR, IE, IT, JP, NL, PL, PT |
| Quantity | 461 devices |
| UPC / GTIN / UDI-DI | 08714729992684 |
| Lot numbers | 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976 |
| Model numbers | M004CRBS3050 |
Product
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Reason for recall
Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation 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-1302-2024. 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.