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Faradrive™ steerable sheath
Official notice
19 Jun 2026
Last checked
19 Jun 2026
An official Health Canada notice concerns Faradrive™ steerable sheath. Boston Scientific is communicating to customers of a forthcoming update to the FARADRIVE™ Steerable Sheath Instructions for Use (IFU).Air embolism is a known procedural risk associated with left atrial ablation procedures utilizing transseptal sheaths and catheter exchanges and is addressed within the device labeling. Boston Scientific continuously monitors product performance and customer feedback as part of its quality system and ongoing product improvement activities. Ongoing product performance monitoring confirms that the FARADRIVE sheath continues to perform within established design, safety, and anticipated product performance expectations. The observed rate of air embolism events remains very low at 0.0134%, consistent with the air embolism incidence of less than 1% reported. Published 2026-06-19.
What to do now
Contact the manufacturer if you require additional information.
Recall number
82221
Official notice
2026-06-19
The hazard
The hazard
Boston Scientific is communicating to customers of a forthcoming update to the FARADRIVE™ Steerable Sheath Instructions for Use (IFU).Air embolism is a known procedural risk associated with left atrial ablation procedures utilizing transseptal sheaths and catheter exchanges and is addressed within the device labeling. Boston Scientific continuously monitors product performance and customer feedback as part of its quality system and ongoing product improvement activities. Ongoing product performance monitoring confirms that the FARADRIVE sheath continues to perform within established design, safety, and anticipated product performance expectations. The observed rate of air embolism events remains very low at 0.0134%, consistent with the air embolism incidence of less than 1% reported.
How to check if you're affected
How to check if you're affected
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Brand: Boston Scientific.
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Documents, notices & source
See the official notice and source documents for full details.
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