Device recall
Z-2541-2020: TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065…
FDA device recall · Class II · Abbott
Key facts
| Recall number (Z-number) | Z-2541-2020 |
|---|---|
| Recall event | 85775 |
| Product | TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an… |
| Product code | OAE |
| Recalling firm | Abbott |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2021 |
| PMA numbers | P130026 |
| 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