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Moderate riskFDA DeviceClass II

Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage

Boston Scientific identified that improper dilator insertion during device setup can damage the hemostatic valve in the FARADRIVE Steerable Sheath. Valve damage may allow air to enter the device, potentially causing air embolism and patient harm. The risk occurs in a subset of affected units when the dilator is not inserted straight through the center of the valve.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

  1. If you use or prepare this device, insert the dilator straight through the center of the hemostatic valve and fully advance it into the sheath body.
  2. Contact Boston Scientific if you have questions about proper insertion technique or if you have already experienced air ingress complaints.
  3. Report any adverse events or complications to Boston Scientific and the FDA.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
400 units
Illnesses reported
None reported
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Classification
Class II
Recall number
Z-2754-2026

In the FDA's words

Description
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01 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. UDI-DI: 00810087181062; Lots: CL12910, CL12978, CL15153 Distribution: Global Distribution. US Nationwide. Affected quantity: 400 units
Hazard
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.

4 products in this recall

Boston Scientific FARADRIVE sheaths recalled for air embolism risk

Boston Scientific found that some air leak complaints were linked to damage to the sheath's hemostatic valve. The damage can happen when the dilator is inserted at the wrong angle during setup, and it may allow air into the device, creating a potential air embolism. This recall covers four FARADRIVE steerable sheath versions, with about 776,000 units affected. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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