Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
WaveCrest Left Atrial Appendage (LAA) Recalled by Biosense Webster, Inc. Due to When attempting to recapture the 32-mm device, the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biosense Webster, Inc. directly.
Affected Products
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Quantity: 25 units
Why Was This Recalled?
When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle, resulting in increased retraction force and difficulty or failure to recapture the device.
Where Was This Sold?
No U.S. Distribution. International Distribution only.
About Biosense Webster, Inc.
Biosense Webster, Inc. has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report