Medline has issued a correction for multiple craniotomy kits after reports of the devices disassembling during use.
The recall affects several lot numbers of kits that include 14mm Codman disposable perforators, which are used during neurological procedures to drill into the skull, according to a July 22 news release from the FDA.
The component, which is manufactured by Integra LifeSciences, may have an inadequate weld, which could cause the device to come apart before, during or after surgery. Potential complications include the tearing of the dura, which is the brain’s protective membrane, bleeding, contusions, permanent brain damage and death.
The correction does not call for removing the products from use — instead, Medline issued instructions April 22 directing facilities to quarantine the affected products, label kits to warn staff to remove the perforators before use and notify recipients.
No injuries or deaths have been reported, the release said.
