Sam Brusco, Associate Editor04.29.24
The U.S. Food and Drug Administration has identified Elekta’s March 15, 2024 recall of its disposable biopsy needles for the Leksell stereotactic system as Class I.
Elekta recalled the disposable biopsy needles from one batch that can contain microscopic stainless steel debris on the inside of the biopsy needle. The material in that debris is stainless steel, which is the same material as the biopsy needle.
If that debris comes loose, it can show up in the biopsy sample and delay or make examination challenging. There’s also a risk of debris being deposited in the brain. The long term functional consequences of this aren’t known, but the metallic debris could cause future MRI scans of the brain to be useless or unable to be obtained.
This could be a serious consequence in a patient with a brain tumor who will need brain MRI surveillance scans for life, with no available alternative.
Elekta has not reported any injuries or deaths related to this issue.
In its March 15 Urgent Recall Notification, Elekta advised customers to remove and dispose all biopsy needles in the affected batch and contact their local Elekta representative to order replacement needle kits. The company also urged posting the notice somewhere that is accessible to all users and to advise appropriate personnel.
It's designed for use with the Leksell Stereotactic System, allowing surgeons to obtain tissue samples accurately and minimally invasively.
Elekta recalled the disposable biopsy needles from one batch that can contain microscopic stainless steel debris on the inside of the biopsy needle. The material in that debris is stainless steel, which is the same material as the biopsy needle.
If that debris comes loose, it can show up in the biopsy sample and delay or make examination challenging. There’s also a risk of debris being deposited in the brain. The long term functional consequences of this aren’t known, but the metallic debris could cause future MRI scans of the brain to be useless or unable to be obtained.
This could be a serious consequence in a patient with a brain tumor who will need brain MRI surveillance scans for life, with no available alternative.
Elekta has not reported any injuries or deaths related to this issue.
In its March 15 Urgent Recall Notification, Elekta advised customers to remove and dispose all biopsy needles in the affected batch and contact their local Elekta representative to order replacement needle kits. The company also urged posting the notice somewhere that is accessible to all users and to advise appropriate personnel.
More about the device
The Leksell Stereotactic System helps doctors locate and diagnose brain disorders. The Disposable Biopsy Needle Kit is used in neurosurgery for precise brain tissue sampling.It's designed for use with the Leksell Stereotactic System, allowing surgeons to obtain tissue samples accurately and minimally invasively.