FDA Device recall Z-1205-2025
VARIPULSE Bi-Directional Ablation Catheter REF D141201
- FDA Device
- Class I
- completed
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class I recall of VARIPULSE Bi-Directional Ablation Catheter REF D141201 by Biosense Webster, citing due to an observed trend of neurovascular events.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1205-2025 |
| Classification | Class I |
| Status | completed |
| Initiated | 2025-01-05 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biosense Webster |
| Distribution | AR, CA, CO, KS, LA, MA, MO, NY, OH, TX |
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 fibrillation. The catheter provides location information when used with the CARTO 3 System.
Reason
Due to an observed trend of neurovascular events
Identifiers
| code_info | Product Number: D141201-12 UDI-DI code: 10846835025460 Batch Numbers: 31483574L 31483560L 31483581L 31483542L 31487313L…Product Number: D141201-12 UDI-DI code: 10846835025460 Batch Numbers: 31483574L 31483560L 31483581L 31483542L 31487313L 31483552L 31483544L 31487311L 31483550L 31483558L 31483575L 31483556L 31487312L 31483553L 31483565L 31483576L 31483547L 31487320L 31483549L 31483561L 31483548L 31483564L 31483541L 31483546L 31483562L 31483566L 31483583L 31483567L |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1205-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.