Device recall
Z-0243-2016: Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152…
FDA device recall · Class II · Medtronic Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-0243-2016 |
|---|---|
| Recall event | 72502 |
| Product | Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080152 AMP253210152 AMP020080152 AMP025080002 AMP030040002 AMP030150152 AMP040120152 AMP335210152… |
| Product code | DQY |
| Recalling firm | Medtronic Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2017 |
| 510(k) numbers | K042624, K050073, K052791, K083919 |
| FEI number | 3001452571 |
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