Elekta Disposable Biopsy Needle Recall Identified as Class I

FDA recently announced that the Elekta Instrumental AB recall of its disposable biopsy needle kit for the Leksell Stereotactic System has been identified as Class I. The Leksell Stereotactic System is used by physicians to locate and diagnose brain disorders. The biopsy needle kit for the system is used for precise brain tissue sampling, allowing for the accurate and minimally invasive collection of tissue.

Elekta is recalling the needles (911933) from one batch (837838839) as it may contain microscopic stainless-steel debris on the inside of the needles. The debris, which is the same material as the needle, has the potential to come loose and may appear in the biopsy sample. If this were to occur, it would delay or make examination of the sample difficult. Additionally, according to the company, there is also a risk of the debris being deposited in the brain, which would cause long-term functional consequences like making future MRI scans of the brain useless or unable to be obtained.

“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,” according to the FDA notice.

The company initially sent customers an Urgent Recall Notification on March 15, requesting all effected product to be removed and disposed of. To order replacement needle kits, Elekta said to contact a company representative.

There have been no reported injuries or deaths associated with the issue.