J&J MedTech and its subsidiary Cerenovus are recalling multiple versions of the Cerepak Detachable Coil Systems due to a higher-than-expected rate of detachment failure, according to an Oct. 2 letter sent to customers.
The issue has been linked to four serious injuries and one death as of Oct. 14. Affected products include various Uniform, Heliform and Freeform coil systems used in embolization procedures for intracranial aneurysms and other neurovascular abnormalities.
Customers were instructed to immediately stop using the devices, identify and segregate affected inventory and notify relevant clinical staff and any external facilities that received the products. No action is required for patients who have already received successful implantations.
The FDA classified the recall as Class I, the most serious type, indicating the potential for serious injury or death if use continues. There is no estimated date for the Cerepak systems’ return to market.
