Device recall
Z-2478-2015: FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F…
FDA device recall · Class III · Abbott Electrophysiology
Key facts
| Recall number (Z-number) | Z-2478-2015 |
|---|---|
| Recall event | 71970 |
| Product | FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional… |
| Product code | MTD |
| Recalling firm | Abbott Electrophysiology |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 23, 2015 |
| 510(k) numbers | K130827 |
| FEI number | 3008847191 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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