Medical Device Recall: 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 Tub
Galt Medical Corporation · June 26, 2026
Reason for Recall
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Product Description
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
Distribution
US Nationwide distribution in the state of MN.
States Affected
NATIONWIDE
Quantity Affected
114,260 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2917-2026
Status: ongoing
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