Faradive Steerable Sheath Clear Recall
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I
Updated June 11, 2026
The Faradive Steerable Sheath Clear used in cardiac catheterization procedures may allow air to enter the bloodstream if the dilator is inserted incorrectly during preparation. This air embolism can cause serious patient harm.
Is the Boston Scientific Corporation recalled? Yes. This product was recalled by FDA on June 11, 2026. Details below.
What is recalled
Faradive Steerable Sheath Clear, Material Number 21M402, IFU Reference Number LBL1062, manufactured by Boston Scientific Corporation and used to access blood vessels and heart chambers during cardiac procedures.
Am I affected
You are affected if you are a healthcare provider or facility using the Faradive Steerable Sheath Clear (Material Number 21M402) for cardiac catheterization.
What to do right now
If you use this device in a medical facility, ensure that when inserting the dilator during preparation, it is inserted straight through the center of the valve and fully advanced into the sheath body to prevent air from entering the patient's bloodstream. Contact Boston Scientific Corporation or your device representative if you have questions about proper insertion technique.
The 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.
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-2755-2026
- Classification
- Class II
- Recalled
- June 11, 2026
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