Device recall
Z-0430-2011: Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Disease Managment
Key facts
| Recall number (Z-number) | Z-0430-2011 |
|---|---|
| Recall event | 57098 |
| Product | Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. |
| Product code | LWP |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Managment |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 29, 2012 |
| PMA numbers | P820003, P820003S072 |
| FEI number | 2182208 |
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