Boston Scientific Enhance Transcarotid/Peripheral Access Kit
Boston Scientific recalls Enhance Transcarotid/Peripheral Access Kits over detachable depth markings.
Check your inventory for Enhance Transcarotid/Peripheral Access Kits with REF SR-4F21G7D-MP (Kit-075-03). Stop using affected kits and contact Boston Scientific for instructions on returning the product and obtaining a replacement.
Recall at a glance
- Quantity recalled
- 114,260 kits
Why it was recalled
Boston Scientific is recalling Enhance Transcarotid/Peripheral Access Kits because black depth markings on the outer sheath of the coaxial dilator introducer component may detach. Detached markings could lead to misplacement of the sheath during procedures, posing a risk of serious injury.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
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
- Lot code
- G22171212, G22201213, G22201214, G22201215, G22201216, G22201217, G22201218, G22234219, G22234220, G22262227, G22234221, G22234222, G22234223, G22262225, G22234224, G22262226, G22262228, G22262229, G22262230, G22292231, G22292232, G22292233, G22292234, G22292235, G22292236, G22292237, G22320238, G22320239, G22320240, G22320241, G22320242, G22320243, G22320244, G22354191, G22362192, G22362194, G22362195, R23083454, G23076104, G23076105 (+191 more, see the official notice)
- UDI-DI
- 00841268107250
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-08-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification