Device recall
Z-1570-2014: Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40…
FDA device recall · Class II · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-1570-2014 |
|---|---|
| Recall event | 67720 |
| Product | Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and… |
| Product code | LKK |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2018 |
| PMA numbers | P860004, P860004S056 |
| 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