VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based
Summary
The FDA issued a Class I for VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter by Biosense Webster, Inc.. Reason: Due to an observed trend of neurovascular events.
Details
Source
Device Recall
External ID
Z-1205-2025
Action Date
2025-03-12
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 497 total catheter - 378 US and 119 OUS
Reason for Recall
Due to an observed trend of neurovascular events
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-05
Company
Irvine, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Biosense Webster, Inc. has 18 FDA actions in our database, including 5 recalls and 13 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biosense Webster, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biosense Webster, Inc. have FDA actions?
Biosense Webster, Inc. has 18 FDA actions in our database, including 5 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1205-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29