FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into… Recall
Issued July 29, 2026 · Boston Scientific Corporation
In July 2026, Boston Scientific Corporation recalled the FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
What you should do
- 1 Stop using FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Boston Scientific Corporation
- Category
- Health
- Recall date
- July 29, 2026
- Units affected
- Not reported
- Sold at
- Global Distribution. US Nationwide.
- Recall number
- FDA-Z-2755-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 39 recalls in our database, including 13 rated Critical.
- We're tracking 3,707 Health recalls in our database.
- This is the 487th Health recall we've logged in 2026.