Device recall
Z-0789-2011: ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide…
FDA device recall · Class I · Ev3, Inc.
Key facts
| Recall number (Z-number) | Z-0789-2011 |
|---|---|
| Recall event | 57335 |
| Product | ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14W020120150, AB14W030080150, AB14W035120150, AB14W035040150, AB14W030120150, AB14W025120150, AB14W040080150… |
| Product code | DQY |
| Recalling firm | Ev3, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 17, 2011 |
| 510(k) numbers | K082854, K090849 |
| FEI number | 2183870 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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