FDA Lists J&J MedTech Cerepak Coil Removal as Most Serious Recall After Death and Injuries

The US Food and Drug Administration has identified Johnson & Johnson MedTech's removal of Cerepak detachable coil systems, made by its subsidiary Cerenovus, as the most serious type of recall. According to the FDA's notice, the coils have shown "a higher-than-expected failure to detach rate," and J&J MedTech had reported four serious injuries and one death associated with the issue as of October 14, 2025.

The agency posted the notice on Thursday, February 5, MedTech Dive reported. The action covers ten Cerepak models: the Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini and Freeform XtraSoft detachable coil systems.

Failure to detach

The FDA said the failure to detach "could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention."

According to the notice, most of the affected models are indicated for embolization of intracranial aneurysms, neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolizations in the peripheral vasculature. The Freeform XtraSoft system is indicated for embolization of intracranial aneurysms.

J&J MedTech sent affected customers a letter on October 2, 2025, telling them to stop using the devices immediately, identify and segregate affected inventory, and return it, the FDA said. The notice says no further action is needed for coils that have already been successfully implanted.

The letter also asked facilities to tell operating room and materials management staff about the issue, to contact any other facility to which recalled product had been forwarded, and to keep the notice posted until all affected product has been returned. The FDA's notice states that the recall involves removing devices from where they are used or sold, and that the device "may cause serious injury or death if you continue to use it."

No date for return to market

"There is currently no estimated date for CEREPAK Detachable Coil Systems to be available again in the market," the FDA said, adding that J&J sales representatives can help identify alternative J&J products.

The FDA's recall database entry for the action, recall number Z-0434-2026, lists Cerenovus Inc. of Miami as the recalling firm, gives October 2, 2025, as the date the firm began the recall, and records 12,004 units in commerce with nationwide US distribution. The entry lists the devices under 510(k) number K220040.

MedTech Dive noted that J&J established its Cerenovus neurovascular business in 2017. Before that, according to the publication, J&J had acquired Cordis and its neurovascular business in 1996, later rebranded Cordis as Codman Neuro, and acquired Micrus Endovascular, Pulsar Vascular and Neuravi.

The FDA said customers in the US with adverse reactions, quality problems or questions about the recall should contact J&J MedTech's Cerenovus unit, and that health care professionals and consumers may report problems with the devices through MedWatch, the agency's safety information and adverse event reporting program.