FDA announces class 1 recall for disposable biopsy needle kit

Editor's Note

Microscopic stainless steel debris on the insides of biopsy needles prompted the FDA to issue a class 1 recall—indicating risk of death or serious injury—for Elekta Instrument’s Disposable Biopsy Needle Kit, which is used with the Leksell Stereotactic System for brain tissue sampling during neurosurgery, the disposable biopsy needle kit

Issued April 26, the recall affects needles from one batch that could contain debris. Made of the same stainless steel as the needles, this debris could appear in the biopsy sample and interfere with examination. It might also end up in the brain, which could result in unknown functional consequences while also making future brain MRIs difficult. According to the FDA report, “This is a serious negative consequence in a patient with a brain tumor who will require brain MRI surveillance scans for life, with no alternative available.”

There have been no reported injuries or deaths associated from this issue. Elekta sent all affected customers an Urgent Recall Notification March 15 urging them to remove and dispose all needles form the affected batch and contact a company representative for replacement needle kits.