Z-2878-2018 Class I Terminated
FDA device recall Z-2878-2018 was initiated by Biosense Webster, Inc. on May 7, 2018 and is designated Class I. Reason for recall: 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. The recall status is terminated (terminated November 14, 2020). Affected quantity: 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2018
- Initiation Date
- May 7, 2018
- Termination Date
- November 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
Product Description
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
Reason for Recall
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.
Distribution Pattern
No U.S. Distribution. International Distribution only.
Code Information
All lots.