Device recall
Z-0121-2007: Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar…
FDA device recall · Class II · Enpath Medical, Inc
Key facts
| Recall number (Z-number) | Z-0121-2007 |
|---|---|
| Recall event | 35983 |
| Product | Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD. Manufactured for Angel Medical Systems, Inc. 1 Shelia Drive, Tinton Falls, NJ; Part No. 0208-2100-001, provided to Angel Medical Systems for International Clinical Studies… |
| Product code | DTB |
| Recalling firm | Enpath Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2007 |
| FEI number | 2183787 |
At a glance
- None 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