Device recall
Z-0174-2014: US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo…
FDA device recall · Class II · St. Jude Medical
Key facts
| Recall number (Z-number) | Z-0174-2014 |
|---|---|
| Recall event | 66597 |
| Product | US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts… |
| Product code | OAD |
| Recalling firm | St. Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2016 |
| PMA numbers | P110016, P110016S003 |
| FEI number | 3005334138 |
At a glance
- None 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