FARADRIVE STEERABLE SHEATH CLEAR Medical Device Recall
Boston Scientific recalls FARADRIVE STEERABLE SHEATH CLEAR due to valve damage risk that could cause air embolism during heart procedures.
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 recall for a medical device with potential for patient harm (air embolism) but no reported injuries or hospitalizations. Risk-of-harm products where injury has not yet been reported warrant a High severity score per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling 74,760 units of the FARADRIVE STEERABLE SHEATH CLEAR, a medical device used to facilitate access to the vasculature and into the chambers of the heart. The recall affects devices with Material Number 21M402 and IFU Reference Number LBL1062, distributed globally and throughout the United States. Complaint investigations identified that improper dilator insertion orientation during device preparation can cause hemostatic valve damage, which may result in air ingress and potential air embolism leading to patient harm. The risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body. Healthcare facilities and patients using affected devices should contact Boston Scientific immediately and follow updated instructions for use. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- 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
- Manufacturer
- Boston Scientific Corporation
- Hazard
- air-embolism
- valve-damage
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 (20)
- UDI-DI: 00810087180072
- Lots: CL12697
- CL12698
- CL12701
- CL12702
- CL12824
- CL12832
- CL12833
- CL12861
- CL12888
- CL12889
- CL12912
- CL12913
- CL12916
- CL12918
- CL12968
- CL12975
- CL12977
- CL13003
- CL13016
Distribution
Distributed nationwide across the United States.
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