Device recall
Z-1205-2025: VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is…
FDA device recall · Class I · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-1205-2025 |
|---|---|
| Recall event | 96170 |
| Product | VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial… |
| Product code | QZI |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class I |
| Status | Completed |
| PMA numbers | P240006 |
| FEI number | 3013300026 |
At a glance
- None 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