Device recall
Z-0537-2018: Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI…
FDA device recall · Class III · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-0537-2018 |
|---|---|
| Recall event | 78406 |
| Product | Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal… |
| Product code | LKK |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 20, 2020 |
| PMA numbers | P860004 |
| FEI number | 2182207 |
At a glance
- None 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