WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
This recall has been terminated (originally issued May 7, 2018).
- Company
- Biosense Webster, Inc.
- Recall Initiated
- May 7, 2018
- Terminated
- November 14, 2020
- Recall Number
- Z-2878-2018
- Quantity
- 25 units
- Firm Location
- Irwindale, CA
- Official Source
- View on FDA website ↗
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
No U.S. Distribution. International Distribution only.
Lot / Code Info
All lots.
Root Cause
Component design/selection
Action Taken
Coherex Medical notified customers via "URGENT FIELD SAFETY NOTICE Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System (32 mm) Catalog No: WCR1523, Lot Number: All" letter dated May 7, 2018. The letter provided an overview, and important information about the product description and codes, lots subject to removal, why customers were being contacted, What actions are required/instructions, available assistance/contact information, and Reply Form.