The FDA issued a safety notice regarding Medline craniotomy kits containing recalled Codman disposable perforators from Integra LifeSciences. The recall stems from an inadequate weld in the 14 mm single-use perforators, potentially causing device separation during neurosurgical procedures.
This issue may lead to severe complications including dura tears, bleeding, brain contusions, irreversible damage, or death. Medline has instructed customers to quarantine affected kits and conduct inventory checks. No injuries or deaths have been reported so far.
The FDA classifies the recall as serious, requiring correction rather than removal from use or sale.
Follow MEDWIRE.AI for critical updates on surgical device safety and recalls.
