Device recall
Z-2631-2011: 1500T14 Cardiac Ablation System - Generator The 1500Tl4 Cardiac Ablation System…
FDA device recall · Class II · St Jude Medical
Key facts
| Recall number (Z-number) | Z-2631-2011 |
|---|---|
| Recall event | 58859 |
| Product | 1500T14 Cardiac Ablation System - Generator The 1500Tl4 Cardiac Ablation System operates in conjunction with a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) electrode. The catheter delivers RF power in a monopolar mode between its distal electrode and the DIP… |
| 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