Biosense Webster, Inc. has recalled approximately 497 VARIPULSE Bi-Directional Ablation Catheters because of an observed trend of neurovascular events in patients. These catheters are medical devices used by doctors to map the heart's electrical signals and treat irregular heartbeats, specifically paroxysmal atrial fibrillation. The recall includes 378 units in the United States and 119 units distributed internationally.
The use of these catheters may cause neurovascular events, which are serious complications that affect the blood vessels in the brain or spine. This can lead to severe health consequences, including stroke, though a specific count of injuries was not provided in the recall notice.
Indicated for cardiac electrophysiological mapping and treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation when used with the TRUPULSE Generator.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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