Device recall
Z-1356-2015: Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Disease Management
Key facts
| Recall number (Z-number) | Z-1356-2015 |
|---|---|
| Recall event | 70763 |
| Product | Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand… |
| Product code | DTE |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 8, 2015 |
| 510(k) numbers | K132924, K150246 |
| FEI number | 2182208 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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