Recall Z-1205-2025— Biosense Webster, Inc.
Class I · Ongoing
Class I FDA medical device recall by Biosense Webster, Inc., initiated 2025-01-05. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Biosense Webster, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-01-05
- Firm location
- Irvine, CA, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.