medical Class I Updated 2018-09-05

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

Distribution: No U.S. Distribution. International Distribution only.
Lot/Code Info: All lots.
View official government recall

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