Boston Scientific recalls transcarotid access kits with potential depth markings that may detach from sheath, causing injury during medical procedures.
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Boston Scientific is recalling transcarotid/peripheral access kits where depth markings on the sheath might detach. This could lead to incorrect positioning during medical procedures, potentially causing injury.
Depth markings on the sheath may detach during use, leading to inaccurate positioning of the medical device. This could cause injury to the patient during transcarotid procedures.
Medical professionals using Boston Scientific's transcarotid access kits with specific model numbers and lot codes listed in the recall. Patients undergoing procedures with these kits are at risk of incorrect positioning.
Check for the model number SR-4F21G7D-MP (Kit-075-03) with lot codes from the list provided in the recall notice. These kits include the sheath with dilator, stiffen dilator, nitinol mandrel wire, and other components.
Immediately stop using the recalled transcarotid access kits with the specified model and lot numbers.
The recalled kit has model number SR-4F21G7D-MP (Kit-075-03).
This kit is used for transcarotid and peripheral access procedures.
Check the lot codes listed in the recall notice, which include specific numbers like G22171212 through G24337704.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2917-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2917-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
