Dive Brief:
- Johnson & Johnson is recalling certain Cerepak detachable coil systems due to a higher-than-expected failure to detach rate that has been associated with four serious injuries and one death. The events were reported as of Oct. 14.
- The failure to detach could result in hemorrhagic and ischemic stroke, procedural delays or the need for additional surgical intervention, according to the Food and Drug Administration, which posted the recall on Thursday.
- J&J issued a letter to customers on Oct. 2 recommending they remove certain Cerepak products from where they are used or sold.
Dive Insight:
The affected Cerepak devices were designed for embolization of intracranial aneurysms. Most are also indicated for treating neurovascular abnormalities such as arteriovenous fistulae — an irregular connection between an artery and a vein — and arterial and venous embolizations in peripheral blood vessels.
Healthcare providers are advised to immediately stop using the affected devices and to return them to the company. No additional action is needed for successfully implanted devices.
There is no estimated date for the coil systems to be available in the market again, according to the FDA’s notice. J&J sales representatives can help customers identify alternative J&J products.
J&J’s Cerenovus neurovascular business, which makes the Cerepak devices, was established in 2017. Prior to launching Cerenvous, J&J acquired Cordis and its neurovascular business in 1996. J&J then rebranded Cordis to Codman Neuro and acquired Micrus Endovascular, Pulsar Vascular and Neuravi.
