Boston Scientific Recalls FARADRIVE STEERABLE SHEATH CLEAR
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Boston Scientific Corporation is recalling 74,760 units of FARADRIVE STEERABLE SHEATH CLEAR 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.
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What Happened
Boston Scientific's complaint investigations identified 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
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart. Material Number 21M402, IFU Reference Number LBL1062. UDI-DI: 00810087180072. Lots: CL12697, CL12698, CL12701, CL12702, CL12824, CL12832, CL12833, CL12861, CL12888, CL12889, CL12912, CL12913, CL12916, CL12918, CL12968, CL12975, CL12977, CL13003, CL13016, CL13019, CL13045, CL13047, CL13059, CL13078, CL13079, CL13101, CL13102, CL13120, CL13121, CL13140, CL13141, CL13158, CL13159, CL13195, CL13211, CL13218, CL13232, CL13233, CL13259, CL13290, CL13339, CL13367, CL13400, CL13421, CL13516, CL13518, CL13572, CL13577, CL13615, CL13645, CL13669, CL13707, CL13720, CL13733, CL13821, CL13834, CL13857, CL13926, CL13941, CL13976, CL13989, CL14026, CL14052, CL14078, CL14121, CL14138, CL14170, CL14186, CL14225, CL14248, CL14285, CL14344, CL14352, CL14374, CL14395, CL14438, CL14487, CL14499, CL14517, CL14580, CL14632, CL14669, CL14690, CL14710, CL14748, CL14768, CL14967, CL15004, CL15008, CL15066, CL15106, CL15127, CL15190, CL15238, CL15271, CL15317, CL15357, CL15396, CL15426, CL15473, CL15489, CL15567, CL15636, CL15639, CL15753, CL15774, CL15807. 74,760 units distributed globally, including US Nationwide. Recall number Z-2755-2026.
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 instructions for use during device preparation.
Why This Matters
This Class II recall addresses a manufacturing-related issue that could lead to air embolism if the device is not prepared correctly.
Source
FDA recall Z-2755-2026, Boston Scientific Corporation, Saint Paul, MN.
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 (2,071 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.