VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiologi…
Biosense Webster, Inc. · Due to an observed trend of neurovascular events
Open FDA's page for this record- Cfres ID
- 212216
- Product res number
- Z-1205-2025
- Event date initiated
- 2025-01-05
- Event date posted
- 2025-02-28
- Recall status
- Completed
- Res event number
- 96170
- Product code
- QZI
- Firm FEI number
- 3013300026
- Recalling firm
- Biosense Webster, Inc.
- Address 1
- 31 Technology Dr Ste 200 31 Technology Dr
- Address 2
- Ste 200
- City
- Irvine
- State
- CA
- Postal code
- 92618-2302
- Additional info contact
- 909-839-8500
- Reason for recall
- Due to an observed trend of neurovascular events
- Root cause description
- Labeling design
- Product quantity
- 497 total catheter - 378 US and 119 OUS
- 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.
- 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
- Action
On 01/05/2025, the firm called and emailed customers to inform them to pause the US External Evaluations and all Varipulse cases due an observed trend in neurovascular events associated with the use of the VariPulse Bi-Directional Ablation Catheters distributed between December 2024 and January 2025. For U.S. Customers, Biosense Webster/JNJ Medtech EP is pausing the US External Evaluation and all US Varipulse cases. Healthcare providers who have treated patients using the products prior to the pause should continue to follow those patients according to their standard of care. For any questions, contact Biosense Webster/JNJ MEDTECH EP representatives On 01/08/2025, the firm released the information on the firm's parent company's website https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-varipulse-u-s-external-evaluation
- Distribution pattern
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
- PMA numbers
- P240006
- Harmonized identifiers (openFDA)
- Device name
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Medical specialty description
- Unknown
- Device class
- 3
- PMA number
- P240006, P250022, P240013, P230017, P240044, P230030
- Registration number
- 3009504230, 3000279201, 3001592626, 3007603855, 3002648230, 1000121056, 2124215, 3008093809, 2182269, 3012263546, 3013403214, 2183744, 2024024, 3008452825, 3008328679, 3004859241, 2032112, 3007648309, 3012693387, 3005334138, 3005012805, 3004016520, 3017060084, 3009243923, 3012520654, 9681260, 3007029079, 9680579, 3013300026, 1319639, 1721686, 2184149, 2182208, 3004105270, 1721983, 3016245399, 1928237, 3012179728, 3004593495, 3012260771 +5 more
- FEI number
- 3009504230, 3000279201, 3001592626, 3007603855, 3002648230, 1000121056, 3002806565, 2124215, 3008093809, 2182269, 3012263546, 3013403214, 2183744, 2024024, 3008452825, 3002806434, 3008328679, 3004859241, 3007648309, 3012693387, 3005334138, 3005012805, 3004016520, 3017060084, 3009243923, 3012520654, 3007029079, 1000064530, 3013300026, 1721686, 3004105270, 2182208, 3016245399, 1928237, 3012179728, 1000139754, 3004593495, 1000138054, 3003076831, 3003248396 +5 more