CanadaThe FARADRIVE™ Steerable Sheath (model/catalogue M004PF21M402; more than 50 lot numbers) from Boston Scientific Corporation is the affected product. Boston Scientific is communicating a forthcoming update to the device Instructions for Use because air embolism is a known procedural risk with left atrial ablation procedures using transseptal sheaths and catheter exchanges (observed rate 0.0134%); contact the manufacturer for additional information.
What's being recalled
Companies: Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752.
How to identify it
Affected products: FARADRIVE™ Steerable Sheath; Lot or serial number: >50 Lot Numbers. Contact MFG; Model or catalogue number: M004PF21M402
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States