FDA-Device2018-09-05Class I
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Biosense Webster, Inc.
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.
Sold states
No U.S. Distribution. International Distribution only.
Affected count
25 units
Manufactured in
15715 Arrow Hwy, N/A, Irwindale, CA, United States
Products
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2878-2018Don't want to check this manually?
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