Device recall
Z-1566-2013: TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12…
FDA device recall · Class II · Loma Vista Medical
Key facts
| Recall number (Z-number) | Z-1566-2013 |
|---|---|
| Recall event | 65343 |
| Product | TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty. |
| Product code | OZT |
| Recalling firm | Loma Vista Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2013 |
| 510(k) numbers | K121083 |
| FEI number | 3009391754 |
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