Device recall
Z-1061-2011: Medtronic SynchroMed implantable drug pump Refill Kits (Model No: 8551, 8555…
FDA device recall · Class I · Medtronic, Inc. - Neuromodulation
Key facts
| Recall number (Z-number) | Z-1061-2011 |
|---|---|
| Recall event | 57651 |
| Product | Medtronic SynchroMed implantable drug pump Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566 The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits are intended for use in refilling Medtronic implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps |
| Product code | LKK |
| Recalling firm | Medtronic, Inc. - Neuromodulation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 4, 2015 |
| PMA numbers | P860004, P990034 |
| 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