Device recall
Z-1338-2012: Medtronic, Model 8870, Application Software Card is part of the SynchroMed II…
FDA device recall · Class II · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-1338-2012 |
|---|---|
| Recall event | 61391 |
| Product | Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes the SynchroMed II implantable drug infusion pump 8637-20, 8637-40, N'Vision clinical programmer 8840 and the Software application card 8870. The SynchroMed II Infusion system… |
| Product code | LKK |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 29, 2016 |
| 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