Integra Recalls Cranial Perforators After Device Defect Causes Injuries

Integra Lifesciences has recalled its Codman cranial perforators due to a defect that can cause the devices to break apart during use, potentially lodging fragments in the skull or causing brain injury. The FDA has linked the issue to 10 injuries, though no deaths have been reported. Affected devices fail to disengage properly, leading to delays, difficulty removing fragments, and bleeding. In April, Integra instructed customers to quarantine and return impacted units after identifying weak welds in certain lots. The FDA has classified five related recalls as Class I, its most serious category. These include over 170,000 disposable perforators and several craniotomy kits from both Integra and Medline Industries. The recall follows previous regulatory scrutiny, including Form 483s and a 2024 FDA warning letter over quality control issues. Integra has since implemented a compliance plan, with shipment holds projected to reach $70 million this year, according to company executives.

22-07-2025