Device recall
Z-0187-2014: Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx…
FDA device recall · Class II · St. Jude Medical
Key facts
| Recall number (Z-number) | Z-0187-2014 |
|---|---|
| Recall event | 66574 |
| Product | Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter. |
| Product code | OAD |
| Recalling firm | St. Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2014 |
| 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