Device recall
Z-2878-2018: WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers…
FDA device recall · Class I · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-2878-2018 |
|---|---|
| Recall event | 80720 |
| Product | WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523. |
| Product code | NGV |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 14, 2020 |
| FEI number | 3003113629 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database