Medline Recalls Craniotomy Kits

Medline Industries is recalling (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable Perforators 14mm. Integra LifeSciences has recalled the perforators due to an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure, a recall notice says.

“The use of affected product may cause serious adverse health consequences, including tears in the membrane surrounding the brain (dura), bleeding, brain tissue bruising (contusions), irreversible brain damage, and death,” the notice says. To date, it says there have been no reported injuries or deaths associated with the issue.

Medline’s device is described as a convenience kit for use during craniotomy procedures. The Codman Disposable Perforators contained in the kits are single-use surgical tools used in neurosurgical procedures to drill access holes into the skull, the notice says.