FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Mater
FDA device recall Z-2755-2026 · posted 2026-07-20 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Action taken
- An Important Medical Device Product Advisory notification letter dated 6/11/26 was sent to customers. Actions " Follow the revised IFU provided in Appendix 1. " Forward this notice to relevant personnel and any facilities to which the product was transferred. " Complete and return the enclosed Acknowledgement Form. " Report any adverse events or quality concerns associated with use of these devices to Boston Scientific via email at BSCComplaints@bsci.com or FDA s MedWatch Adverse Event Reporting program [www.fda.gov/MedWatch/report.htm or 1.800.FDA.1088 (332.1088)]. If you require additional assistance or more information regarding this communication, please contact your local Boston Scientific representative.
- Root cause
- Use error
- Status
- Open, Classified
- Product code
- DRA
- Quantity affected
- 74,760 units
- Distribution
- Global Distribution. US Nationwide.
- Date initiated
- 2026-06-11
- Date posted
- 2026-07-20
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FARADRIVE™ Steerable Sheath (K233248) | Boston Scientific Corporation | 2023-12-11 |