Device recall
Z-2630-2011: 1500T12 Cool Path Ablation System - Generator The generator is a…
FDA device recall · Class II · St Jude Medical
Key facts
| Recall number (Z-number) | Z-2630-2011 |
|---|---|
| Recall event | 58859 |
| Product | 1500T12 Cool Path Ablation System - Generator The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The generator has a maximum power output of 100 Watts. The catheter delivers the RF power from the generator in a monopolar… |
| Recalling firm | St Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2012 |
| FEI number | 3007562768 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
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