FDA Medical devices recall ·
VARIPULSE Bi-Directional Ablation Catheter recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1205-2025
- Date
- (initiated January 5, 2025)
- Company / brand
- Biosense Webster, Inc.
31 Technology Dr Ste 200, Irvine, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Completed
- Units affected
- 497 total catheter - 378 US and 119 OUS
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to an observed trend of neurovascular events
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide distribution; US states of AR, CA, CO, KS, LA, MA, MO, NY, OH and TX. EMEA, New Zealand, Saudi Arabia, Oman, United Ecuador, Panama, South Africa, China Austria Belgium Czech Republic France Germany Hungary Ireland Israel Italy UK Sweden Norway Denmark Finland Luxembourg Netherlands Poland Portugal Slovenia Spain Switzerland Serbia United Arab Emirates Croatia Canada South Korea Japan
States: Arkansas California Colorado Kansas Louisiana Massachusetts Missouri New York Ohio Texas
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1205-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.