Recall Z-2757-2026 · DRA Catheter, Steerable
Boston Scientific Corporation
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
| Date | Jul 20, 2026 (initiated Jun 11, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Use error |
| Action | 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 |
| Quantity | 193,000 units |
| Distribution | Global Distribution. US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233248 | FARADRIVE Steerable Sheath Boston Scientific Corporation, Dec 11, 2023 |