Device recall
Z-0981-2012: EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-0981-2012 |
|---|---|
| Recall event | 60577 |
| Product | EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of… |
| Product code | OAE |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2012 |
| PMA numbers | P030031 |
| FEI number | 3003113629 |
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