FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the h… 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.

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062

Quantity: 74,760 units

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Company

Boston Scientific Corporation, Saint Paul, MN

Date

Wednesday, July 29

Severity

Class II
the product could cause temporary or reversible health problems.

Where sold

Nationwide
Global Distribution. US Nationwide.

Status

Ongoing

Recall number

Z-2755-2026

Source

U.S. Food and Drug Administration