FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, M

FDA device recall Z-2757-2026 · 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

193,000 units

Distribution

Global Distribution. US Nationwide.

Date initiated

2026-06-11

Date posted

2026-07-20

Location

Saint Paul, MN

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