Device recall
Z-0496-2013: SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10…
FDA device recall · Class I · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-0496-2013 |
|---|---|
| Recall event | 63712 |
| Product | SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient… |
| Product code | LKK |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 31, 2017 |
| 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