Recall Monitor
Health Products

FARADRIVE™ Steerable Sheath

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: FARADRIVE™ Steerable Sheath
Issue: Medical devices - Labelling and packaging
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
FARADRIVE™ Steerable Sheath>50 Lot Numbers. Contact MFGM004PF21M402

Issue

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.

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