FARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk
Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving risk-of-harm potential (air embolism) where injury has not yet been reported. Air embolism represents a serious but theoretical risk without explicit injury reports in the source text.
Plain-English summary
Boston Scientific Corporation is recalling 400 units of the FARADRIVE Steerable Sheath Clear IDE, a medical device used to facilitate access to blood vessels and heart chambers. The recall affects lots CL12910, CL12978, and CL15153 and is distributed globally with U.S. nationwide distribution.
Investigation found that improper dilator insertion orientation during device preparation can damage the hemostatic valve, potentially allowing air to enter the bloodstream. Air embolism is a serious condition where air bubbles in the bloodstream can block circulation and cause patient harm.
Healthcare providers should immediately check inventory for affected lots and follow the manufacturer's instructions for safe dilator insertion. If a device has been used, clinical monitoring should be considered. Patients who have received the device should be monitored for signs of air embolism.
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
- Manufacturer
- Boston Scientific Corporation
- Hazard
- air-embolism
- valve-damage
- medical-device-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: 00810087181062
- Lots: CL12910
- CL12978
- CL15153
Distribution
Distributed nationwide across the United States.
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