VARIPULSE Bi-Directional Ablation Catheter REF D141201 — Class I medical device recall Z-1205-2025
Completed recall by Biosense Webster, Inc., reported 2025-03-12, distributed in AR, CA, CO, KS, LA, MA, MO, NY…. Due to an observed trend of neurovascular events
| Recall number | Z-1205-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irvine, CA, United States |
| Recall initiated | 2025-01-05 |
| Classified | 2025-02-28 |
| Reported by FDA | 2025-03-12 |
| Distributed | AR, CA, CO, KS, LA, MA, MO, NY, OH, TX |
| Countries outside the US | AE, AT, BE, CA, CH, CN, CZ, DE, DK, EC, ES, FI, FR, GB, HR, HU, IE, IL, IT, JP, KR, LU, NL, NO, NZ, OM, PA, PL, PT, RS, SA, SE, SI, ZA |
| UPC / GTIN / UDI-DI | 10846835025460 |
| Lot numbers | 31483541L, 31483542L, 31483544L, 31483546L, 31483547L, 31483548L, 31483549L, 31483550L, 31483552L, 31483553L, 31483556L, 31483558L, 31483560L, 31483561L, 31483562L, 31483564L, 31483565L, 31483566L, 31483567L, 31483574L, 31483575L, 31483576L, 31483581L, 31483583L, 31487311L, 31487312L, 31487313L, 31487320L |
| Model numbers | D141201 |
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 for recall
Due to an observed trend of neurovascular events
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1205-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.