Device recall
Z-2200-2016: Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog…
FDA device recall · Class II · Medtronic Inc., Cardiac Rhythm and Heart Failure
Key facts
| Recall number (Z-number) | Z-2200-2016 |
|---|---|
| Recall event | 74424 |
| Product | Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a… |
| Product code | LDF |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 13, 2018 |
| 510(k) numbers | K042190 |
| FEI number | 2182208 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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