Device recall
Z-1148-2008: Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-10. The contents…
FDA device recall · Class I · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-1148-2008 |
|---|---|
| Recall event | 46685 |
| Product | Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve, screened side catheter access port and suture loops. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN… |
| Product code | LKK |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 6, 2011 |
| PMA numbers | P860004, P990034 |
| FEI number | 2182207 |
At a glance
- None Linked 510(k)s
- 10–99 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