Device product
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Z-2878-2018
Product summary
- Event
- Event 80720
- Status
- Terminated
- Classification
- Class I
- Quantity
- 25 units
- Official record key
device-enforcement:Z-2878-2018
Official wording
Reason: 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.
Code information: All lots.
Distribution pattern: No U.S. Distribution. International Distribution only.
Derived failure modes
-
Unknown
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.