Device recall
Z-1060-2011: Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II…
FDA device recall · Class I · Medtronic, Inc. - Neuromodulation
Key facts
| Recall number (Z-number) | Z-1060-2011 |
|---|---|
| Recall event | 57651 |
| Product | Medtronic SynchroMed II (Model No: 8637) implantable drug pump The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: " Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile… |
| 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