Johnson & Johnson interventional radiology device faces recall after patient death, FDA says
Johnson & Johnson is recalling an interventional radiology device following four patient injuries and one death, the U.S. Food and Drug Administration announced Thursday.
The voluntary action pertains to certain Cerepak Detachable Coil Systems, used to treat brain aneurysms and other neurovascular abnormalities.
Such hemorrhages can lead to complications including stroke, permanent nerve damage or death, with the devices involving the insertion of coils into an aneurysm to fill up space and induce clotting to prevent a rupture. However, J&J MedTech said providers have faced challenges with detaching the system at a “higher than expected” rate.
“The failure to detach could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention,” the FDA noted in its Feb. 5 alert.
This is a Class 1 recall, the agency’s most serious designation, meaning misuse of the coil system could result in serious injuries or death. J&J MedTech—and its subsidiary stroke business, Cerenovus Inc.—are advising providers to identify and segregate all impacted devices. The company previously sent a notice to customers in October, urging them to immediately cease use of the coils and communicate this issue to relevant operating room and materials management personnel.
Models impacted include the Cerepak Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, and Freeform Mini Detachable Coil Systems, according to the FDA. All are indicated for embolization of intracranial aneurysms, neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and arterial and venous embolization in the peripheral vasculature. The Freeform XtraSoft is specifically geared toward embolization of intracranial aneurysms, authorities noted.
Johnson & Johnson launched Cerenovus in 2017 after combining its acquisitions of Pulsar Vascular and Neuravi into a single entity focused on therapies for stroke and other vascular conditions. In 2024, it was announced that Cerenovus and several other brands would be known as Johnson & Johnson MedTech.
In 2025, anonymous sources told the Financial Times that Johnson & Johnson was exploring a sale of Cerenovus at an asking price of over $1 billion. In the year since that news was first reported, there have been no further updates.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.