Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic Attack
This recall involves updating the Instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
- Product Name: Varipulse Bi-Directional Ablation Catheter (Varipulse Platform)
- Unique Device Identifier (UDI): 10846835025460 (GTIN)
- Lot/Serial Numbers: All lots and serial numbers
What to Do
On February 14, 2025, Johnson & Johnson MedTech (parent company of Biosense Webster) sent all affected customers an urgent medical device recall (correction) letter to provide an update to its January communication about a pause in the U.S. External Evaluation. The February letter recommends the following actions for health care providers:
- Review findings from the company’s investigation into the reported peri-procedural strokes and adhere to the updated Instructions for Use, including the indications for use (that is, for the treatment of symptomatic drug refractory paroxysmal atrial fibrillation).
- Share the available information in the Instructions for Use with patients to determine whether the balance of risk and benefits support using the device, considering the patient’s individual situation.
- Be aware there is a planned U.S. Post-Approval Study to further investigate the benefits and risks associated with the use of the Varipulse ablation catheter for the treatment of paroxysmal atrial fibrillation.
- Be aware of the known and inherent risk of neurovascular events, such as stroke and TIA, that may occur during catheter-based ablation procedures for rapid, irregular heartbeats (atrial fibrillation).
- Continue to follow patients who received ablation procedures with the device according to their standard of care, as with any ablation procedure.
- Ensure that anyone in the provider’s facility who needs to be aware of this notification reads the company’s letter carefully.
- Keep a copy of the company’s letter in your facility records.
This letter follows an announcement in January 2025 that Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases.
Reason for Updates to Use Instructions
Biosense Webster updated the use instructions for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack (TIA or “mini stroke”) seen in the first 132 procedures after FDA approval in November 2024. Biosense Webster limited its distribution to a few U.S. hospitals to get more feedback from doctors, called the Varipulse U.S. External Evaluation. Of 132 patients treated with the device during the U.S. External Evaluation, four patients (about 3%) had a stroke or mini stroke shortly after the surgery. The frequency of stroke or mini stroke in the U.S. External Evaluation exceeded the frequency expected for this type of surgery (typically 1% or less).
Biosense Webster investigated the surgeries where patients had a stroke or mini stroke and found some differences between how the device was used and the recommendations in the use instructions. These differences could explain the higher risk of stroke or mini stroke and include treatment of patients with a more advanced form of irregular heart rhythm, more energy deliveries to the heart, repeated energy deliveries to the same location in the heart, and energy deliveries to locations not studied in clinical trials. Based on the available data that may link these differences to stroke or mini stroke, Biosense Webster recommends using the device only as studied, which is reflected in the updated use instructions.
The use of affected product may cause serious adverse health consequences, including stroke, mini stroke, and death. Biosense Webster has reported four serious injuries associated with this issue.
Device Use
The Varipulse catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a 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. The device is intended for adults 22 years old and above.
Contact Information
Customers in the U.S. with questions should contact Biosense Webster, Inc. at OneMD-Field-Actions@its.jnj.com with the subject: Attention: BWI Field Action Coordinator.
Additional FDA Resources
Additional Company Resources
- Press Release: Johnson & Johnson to Resume U.S. Varipulse Cases [02/14/2025]
- Press Release: Johnson & Johnson Statement on Varipulse U.S. External Evaluation [01/08/2025]
Unique Device Identifier (UDI)
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How do I report a problem?
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