Boston Scientific Corporation: Catheter, Steerable

Recalling firm

Boston Scientific Corporation

Product

FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01

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.

Classification

Class II

Category

medical device recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-06-11

Status

Open, Classified

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Global Distribution. US Nationwide.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/ef156c56-dfdb-457e-9b2a-8d4cee65a792