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Biosense Webster, Inc. recalls WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Recalled September 5, 2018 · FDA recall Z-2878-2018 · Biosense Webster
Hazard
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. · FDA Class I
Units
25 units
Sold at
No U.S. Distribution. International Distribution only.
Description
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.
Product
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Manufacturer(s)
Biosense Webster, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →