Class II — Galt Medical Corporation
| Recalling firm | Galt Medical Corporation |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. |
| 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 |
| Quantity | 114,260 kits |
| Distribution | US Nationwide distribution in the state of MN. |
| Initiated | 2026-06-26 |
| Classified | 2026-08-07 |
| Recall number | Z-2917-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Galt Medical Corporation (Z-2917-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99369/
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