Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF:… — Class II medical device recall Z-2917-2026
Ongoing recall by Galt Medical Corporation, reported 2026-08-19, distributed nationwide. Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcaro
| Recall number | Z-2917-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Galt Medical Corporation, Garland, TX, United States |
| Recall initiated | 2026-06-26 |
| Classified | 2026-08-07 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 114,260 kits |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00841268107250 |
| Lot numbers | G22171212, G22201213, G22201214, G22201215, G22201216, G22201217, G22201218, G22234219, G22234220, G22234221, G22234222, G22234223, G22234224, G22262225, G22262226, G22262227, G22262228, G22262229, G22262230, G22292231, G22292232, G22292233, G22292234, G22292235, G22292236, G22292237, G22320238, G22320239, G22320240, G22320241, G22320242, G22320243, G22320244, G22354191, G22362192, G22362193, G22362194, G22362195, G23076104, G23076105 and 191 more |
| Model numbers | SR-4F21G7D-MP |
Product
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
Reason for recall
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
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-2917-2026. 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.