Device recall
Z-0716-2017: Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21…
FDA device recall · Class II · Sorin Group USA, Inc.
Key facts
| Recall number (Z-number) | Z-0716-2017 |
|---|---|
| Recall event | 75570 |
| Product | Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The… |
| Product code | LWR |
| Recalling firm | Sorin Group USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 3, 2017 |
| PMA numbers | P150011 |
| FEI number | 1718850 |
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