Biosense Webster, Inc. recalls WaveCrest Left Atrial Appendage (LAA), Occlusion System (32
Recalled Product
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Hazard / Issue
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.
Issued by
FDA
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