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Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse Due to High Rate of Stroke or Transient Ischemic Attack
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.
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.
Questions?
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.
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