Device recall
Z-1148-2017: AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single…
FDA device recall · Class II · AtriCure, Inc.
Key facts
| Recall number (Z-number) | Z-1148-2017 |
|---|---|
| Recall event | 76017 |
| Product | AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2… |
| Product code | FZP |
| Recalling firm | AtriCure, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2018 |
| 510(k) numbers | K160454 |
| FEI number | 3011706110 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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