Device recall
Z-0111-2026: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF…
FDA device recall · Class I · Abbott
Key facts
| Recall number (Z-number) | Z-0111-2026 |
|---|---|
| Recall event | 97595 |
| Product | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter |
| Product code | OAE |
| Recalling firm | Abbott |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P220013 |
| 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