Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dila… recall
Galt Medical Corporation recalled Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dila… on August 19, 2026 because of black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. It was sold nationwide.
Why it was recalled
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
What's recalled
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
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Galt Medical Corporation, Garland, TX
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the state of MN. - Status
- Ongoing
- Recall number
- Z-2917-2026
- Source
- U.S. Food and Drug Administration
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