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
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
| Recalling firm | Galt Medical Corporation |
|---|---|
| Reason | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Aug 19, 2026 |
| Initiated | Jun 26, 2026 |
| Region | TX, United States |
| Distribution | US Nationwide distribution in the state of MN. |
| Quantity | 114,260 kits |
| Code/Lot | UDI:00841268107250/Lot: G22171212 G22201213 G22201214 G22201215 G22201216 G22201217 G22201218 G22234219 G22234220 G22262227 G22234221 G22234222 G22234223 G22262225 G22234224 G22262226 G22262228 G2226… |
| Type | Voluntary: Firm initiated |
| Recall number | Z-2917-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-2917-2026)
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