Public recall detail

FARADRIVE™ Steerable Sheath

2026-06-19

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Health products Health product recall
Quick summary

Quick summary: FARADRIVE™ Steerable Sheath. Reason: Health product recall. Category: Health products. Date: 2026-06-19.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: FARADRIVE™ Steerable Sheath. Reason: Health product recall. Category: Health products. Date: 2026-06-19.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBOSTON SCIENTIFIC CORPORATION
ProductFARADRIVE™ Steerable Sheath
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-82221

Affected products

ProductFARADRIVE™ Steerable Sheath
Lot>50 Lot Numbers. Contact MFG
ModelM004PF21M402
Serial number>50 Lot Numbers. Contact MFG
DescriptionFARADRIVE™ Steerable Sheath

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesBoston Scientific Corporation300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Recall date2026-06-11
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82221
Background{}
CompaniesBoston Scientific Corporation300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
AudiencesHealthcare
Source updated2026-06-19

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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