FDA RECALL UPDATE: Biosense Webster Varipulse Use Instructions
Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack. The post FDA RECALL UPDATE: Biosense Webster Varipulse Use Instructions appeared first on MedTech Intelligence.
FDA RECALL NOTIFICATION
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…READ MORE
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