Recall Z-2878-2018 ยท NGV System, Appendage Closure, Left Atrial
Biosense Webster, Inc.
WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
| Date | May 7, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 25 units |
| Distribution | No U.S. Distribution. International Distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.