Boston Scientific Transcarotid Kit Sheath Depth Markings May Detach
Boston Scientific recalls transcarotid access kits with potential depth markings that may detach from sheath, causing injury during medical procedures.
Use caution until it’s fixed
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
What happened, in plain English
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. Read more at govinfonow.com/recall/459451-boston-scientific-transcarotid-kit-sheath-depth-markings-may-detach.
Source Summary by GovInfoNow · govinfonow.com/recall/459451-boston-scientific-transcarotid-kit-sheath-depth-markings-may-detach · Updated August 27, 2026 · FDA enforcement record: FDA #Z-2917-2026
Cite this page
“Boston Scientific Transcarotid Kit Sheath Depth Markings May Detach.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/459451-boston-scientific-transcarotid-kit-sheath-depth-markings-may-detach. Based on FDA recall #Z-2917-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2917-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Stop Using Kit
Immediately stop using the recalled transcarotid access kits with the specified model and lot numbers.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of MN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2917-2026 (June 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2917-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.