Reported Sep 5, 2018 · Terminated
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Biosense Webster, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biosense Webster, Inc. · 15715 Arrow Hwy · Irwindale, CA · 91706-2006
Is this the product you have?
WaveCrest Left Atrial Appendage (LAA)Occlusion System (32 mm)Catalog Numbers WCR1523 and WCR2523
- Lot codes and dates
- All lots.
- Amount recalled
- 25 units
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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