Device recall
Z-1042-2022: Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO…
FDA device recall · Class II · Medtronic Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-1042-2022 |
|---|---|
| Recall event | 89935 |
| Product | Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P ADM05008013P ADM05008013P… |
| Product code | ONU |
| Recalling firm | Medtronic Vascular, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P140010 |
| FEI number | 3001452571 |
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