Device recall
Z-0892-2017: ev3, PowerCross.018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross…
FDA device recall · Class II · Medtronic Inc
Key facts
| Recall number (Z-number) | Z-0892-2017 |
|---|---|
| Recall event | 75780 |
| Product | ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic… |
| Product code | LIT |
| Recalling firm | Medtronic Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 2, 2017 |
| 510(k) numbers | K093286 |
| FEI number | 3001504994 |
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