Device recall
Z-0814-2024: TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F…
FDA device recall · Class II · St. Jude Medical, Atrial Fibrillation Division, Inc.
Key facts
| Recall number (Z-number) | Z-0814-2024 |
|---|---|
| Recall event | 93711 |
| Product | TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile. |
| Product code | OAE |
| Recalling firm | St. Jude Medical, Atrial Fibrillation Division, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P130026 |
| FEI number | 1000139754 |
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