FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk
The U.S. Food and Drug Administration (FDA) has announced a new recall for the ablation catheters associated with Johnson & Johnson MedTech’s Varipulse pulsed field ablation (PFA) system. No devices need to be returned or removed from the market. Instead, the FDA is urging all customers to read updated instructions provided by Johnson & Johnson MedTech.
The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack shortly after treatment. The expected stroke rate is closer to 1%, the FDA explained, prompting this action.
In total, four serious injuries have been linked to this issue.
This is a Class I recall, which means the FDA believes patients face a risk of serious injury or death if they use the devices without reviewing the updated instructions.
These safety concerns provide additional context after Johnson & Johnson MedTech paused the U.S. rollout of its Varipulse PFA system in early January and then resumed its rollout nearly six weeks later.
Johnson & Johnson MedTech’s recommendations for Varipulse users
Johnson & Johnson MedTech has shared a letter with all of its customers highlighting several recommendations for the use of its Varipulse PFA system going forward. Those recommendations include:
- Review findings from the company’s investigation into the reported periprocedural strokes and adhere to the updated instructions.
- Share this information with patients when determining if treatment with this PFA system is right for them.
- Be aware of a planned U.S. post-approval study designed to further investigate the benefits and risks associated with this device.
- Be aware of the known and inherent risk of neurovascular events that may occur during catheter-based ablation procedures.
- Follow patients who received ablation procedures with the device according to their standard of care.
- Ensure that your facility is aware of these concerns and the updated instructions.
- Keep this information in your facility’s records.
Click here for the full FDA advisory.
Johnson & Johnson MedTech previously noted that these issues do not impact Varipulse cases performed outside the U.S. due to the “unique platform configuration” used to evaluate U.S. cases.
Recall follows FDA approval in 2024
Johnson & Johnson MedTech first gained FDA approval for the Varipulse PFA system in November 2024. The agency had previously approved Medtronic’s PulseSelect and Affera systems and Boston Scientific’s Farapulse system.
The FDA made its decision after reviewing data from the admIRE clinical trial, which included 277 patients who underwent treatment with the Varipulse system throughout the United States. The study linked PFA with Varipulse to acute procedural success in 100% of patients and a primary effectiveness success rate of 75%.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.