Device recall
Z-1062-2011: Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The…
FDA device recall · Class I · Medtronic, Inc. - Neuromodulation
Key facts
| Recall number (Z-number) | Z-1062-2011 |
|---|---|
| Recall event | 57651 |
| Product | Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller… |
| Product code | LKK |
| Recalling firm | Medtronic, Inc. - Neuromodulation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 4, 2015 |
| PMA numbers | P860004 |
| 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