The FDA has flagged J&J Medtech’s recall of its Cerepak detachable coils as Class I in the wake of one death and four serious injuries.
In October, J&J Medtech and its subsidiary Cerenovus issued the voluntary recall in a letter calling on affected customers to remove the products from their shelves. The action was taken due to a higher-than-expected failure to detach rate that can result in hemorrhagic and ischemic stroke, procedural delays and additional surgery, according to a recall notice on the FDA’s website.
“This device may cause serious injury or death if you continue to use it,” the regulatory agency said in the notice. The FDA’s Class I designation is reserved for products that are reasonably likely to “cause serious adverse health consequences or death” when used.
A J&J MedTech spokesperson told Fierce: “At Johnson & Johnson MedTech, patient safety is a core priority, which is why we initiated a voluntary recall of CEREPAK Detachable Coil Systems in October following an internal evaluation indicating that the rate of failure to detach may be higher than anticipated. We are engaging with the FDA and providing alternative solutions to our customers.”
The devices were designed to provide embolization of intracranial aneurysms, neurovascular abnormalities and venous embolizations in the peripheral vasculature.
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The recall includes multiple versions of the Cerepak Uniform, Heliform and Freeform detachable coil systems.
Currently, the FDA said, there is no estimated date for when the devices will be available, and J&J Medtech is working to identify alternatives to the products. The notice provides a full list of the recalled products.
The recall classification comes almost a year to the day J&J Medtech restarted the U.S. rollout of its Varipulse pulsed field ablation system a month after it was paused following reports of four strokes among treated patients.
The company said at the time that it found no immediate device- or procedure-related factors and that the system operated as intended to treat atrial fibrillation.
Still, J&J said the risk of neurovascular complications could escalate if a high number of ablations are delivered or if ablations are stacked on top of one another to create deeper lesions within the cardiac tissue.
