FARADRIVE™ Steerable Sheath Recall: IFU Update
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Boston Scientific is issuing an update to the Instructions for Use for the FARADRIVE™ Steerable Sheath due to the known risk of air embolism during procedures.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on July 18, 2026 and geographically references Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, medical-device.
What Happened
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.
Which Products Are Affected
FARADRIVE™ Steerable Sheath Model or catalogue number: M004PF21M402
50 Lot Numbers. Contact MFG
What You Should Do
Boston Scientific continuously monitors product performance and customer feedback. No specific consumer action is detailed in the recall notice.
Why This Matters
The observed rate of air embolism events remains very low at 0.0134%, consistent with the air embolism incidence of less than 1% reported.
Source
Original source: Health Canada Official Notice ↗
Related Product & Food Recalls
All Product & Food Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (901 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 18, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.