Boston Scientific FARADRIVE Steerable Sheath Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Boston Scientific is recalling 400 units of FARADRIVE Steerable Sheath Clear IDE due to risk of air ingress from hemostatic valve damage.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references United States. 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 - FDA 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, fda, Devices.
What Happened
Boston Scientific Corporation initiated a recall after identifying that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm.
Which Products Are Affected
The recall affects FARADRIVE Steerable Sheath Clear IDE (Material Number 21C602, IFU Reference Number 51636751-01), used to facilitate access to the vasculature and into the chambers of the heart. UDI-DI: 00810087181062. Affected lots: CL12910, CL12978, CL15153. A total of 400 units are involved in the global distribution, including US Nationwide.
What You Should Do
The risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body. Consumers should follow the provided preparation instructions.
Why This Matters
Valve damage may result in air ingress, potential air embolism, and associated patient harm.
Source
FDA recall number Z-2754-2026. Classification: Class II. Report date: 20260729.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA 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 (1,138 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.