Integra received Form 483s last year after the FDA deemed devices including cranial perforators to be noncompliant with quality system regulations. Later in 2024, the FDA sent a warning letter in ...

The defect has resulted in problems including a procedural delay, difficulty removing device fragments and bleeding, the FDA ...

The FDA is amplifying an effort underway at medical device distributor Medline that aims to correct certain neurosurgery kits ...

The Food and Drug Administration has identified a Class I recall of certain lots of Medline Industries Craniotomy ...

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 ...

The FDA issued a notice warning of an issue with certain Medline craniotomy kits due to an Integra LifeSciences perforator recall.

Medical devices are essential to patient safety, addressing critical issues in devices that may pose health risks. Here are some of the latest recalls reported to the FDA: Integra LifeSciences has ...

Small perforators arise from the proximal PCAs, which supply the cerebral peduncle as well as the thalamus (the latter known as thalamoperforators). Infarctions in the territory of the PCA most often ...

Between January 2005 and August 2015, the FDA received more than 300 medical device reports (MDRs) of automatic clutch mechanisms failing to disengage, resulting in more than 200 injuries, the ...