Device recall
Z-0022-2007: Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10…
FDA device recall · Class I · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-0022-2007 |
|---|---|
| Recall event | 35595 |
| Product | Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the… |
| Product code | LKK |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 6, 2010 |
| PMA numbers | P860004, P860004S042 |
| 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