Device recall
Z-0120-2007: Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model…
FDA device recall · Class II · Enpath Medical, Inc
Key facts
| Recall number (Z-number) | Z-0120-2007 |
|---|---|
| Recall event | 35983 |
| Product | Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214. All labeled Sterile, EO, mail: Enpath Medical, Inc. Lead Technologies Division, Minneapolis, MN 55439 USA. |
| Product code | DTB |
| Recalling firm | Enpath Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2007 |
| 510(k) numbers | K870562 |
| FEI number | 2183787 |
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