The US Food and Drug Administration (FDA) has classified the recall of Johnson & Johnson (J&J) MedTech’s CEREPAK Detachable Coil Systems as Class I, following one patient death and four serious injuries associated with a fault in the aneurysm treatment product range.
On 2 October 2025, J&J MedTech sent a letter to all affected customers recommending that all affected products be removed from use immediately.
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J&J MedTech said that Cerepak’s market removal was related to a ‘higher-than-expected’ failure-to-detach rate, an issue that it added could result in haemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
J&J MedTech’s Cerepak products were first introduced in 2023, and are used to treat intracranial aneurysms during endovascular neurosurgery procedures. Designed to enhance tracking through tortuous or twisted anatomy, the coil systems are used to promote blood clotting within the aneurysm sac.
J&J MedTech has stated that there are currently no plans for the device to be reintroduced to the market.
Cerepak is a product that is part of J&J MedTech’s neurovascular business. The division was created in 2017 following the company’s acquisition of Pulsar Vascular and Neuravi, and previously went by the name CERENOVUS. However in October 2024, J&J MedTech chose to dispense with this moniker and market its neurovascular product range under its broader J&J MedTech name.
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By GlobalDataIn February 2025, reports emerged that J&J MedTech was mulling the sale of its neurovascular business, although no such deal has since materialised.
