Device recall
Z-1621-2014: InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110…
FDA device recall · Class II · InterValve Inc
Key facts
| Recall number (Z-number) | Z-1621-2014 |
|---|---|
| Recall event | 67964 |
| Product | InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty. |
| Product code | OZT |
| Recalling firm | InterValve Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2014 |
| 510(k) numbers | K133607 |
| FEI number | 3010133561 |
At a glance
- 1–9 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