Earlier this fall, Elekta issued a recall of one lot of their Disposable Biopsy Needle Kits after discovering debris inside the needle. The FDA has listed this as a Class 1 recall.
Surgeons use Elekta’s Disposable Biopsy Needle Kit in conjunction with the Leksell Stereotactic System for taking samples of brain tissue during brain surgery and biopsy. Biopsies are used to diagnose cancer and other medical conditions.
Elekta announced the recall on September 25, 2004. The lot number for the recalled biopsy needle kit is 873874875R. The kit includes three packages — one with six needles, one with a single needle, and a third with a single needle in an inner sterile bag. The Unique Device Identifiers for the three components of the kit are as follows:
- (01)0 7340048 30034 6 (17) 260401 (10) 873874875R (240) 911933
- (01)0 7340048 30800 7 (17) 260301 (10) 873874875R (240) 911761
- (01)0 7340048 30801 4 (17) 260301 (10) 873874875R (240) 912465
Only one lot of disposable kits has been included in the recall thus far.
While no injuries or deaths have been reported in connection to Elekta’s Disposable Biopsy Needle Kits, use of the recalled product puts patients at serious risk. The company discovered microscopic stainless steel debris inside the needle in the affected lot. If used during biopsy, the debris could be transferred to the patient’s brain tissue. Introducing foreign debris into brain tissue would put the patient at risk for serious damage and, in extreme cases, could be fatal.
Elekta advises all providers and facilities to stop using biopsy needle kits from lot number 873874875R and to discard all kits immediately. Customers can contact the company to arrange for appropriate replacements.
Anyone with questions or concerns about the recall can contact Elekta at (855) 693-5358.
Patients and health care providers can report any new adverse health events related to use of Elekta’s Disposable Biopsy Needle Kits through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to use of Elekta’s Disposable Biopsy Needle Kits, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to customers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.