Health Canada19 Jun 2026
FARADRIVE™ Steerable Sheath
Health Canada published a recall notice for FARADRIVE™ Steerable Sheath on 19 Jun 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 19 Jun 2026
- Recall type
- Health product recall
- Companies
- Boston Scientific Corporation300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
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. Additional information Details Original published date: 2026-06-19 Affected products: Affected products Lot or serial number Model or catalogue number FARADRIVE™ Steerable Sheath >50 Lot Numbers. Contact MFG M004PF21M402 Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.