This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
- Product Name: Elekta Disposable Biopsy Needle Kit
- Unique Device Identifier (UDI):
- Package including 6 needles: (01)0 7340048 30034 6 (17) 260401 (10) 873874875R (240) 911933
- Package including 1 needle: (01)0 7340048 30800 7 (17) 260301 (10) 873874875R (240) 911761
- Inner sterile bag including 1 needle: (01)0 7340048 30801 4 (17) 260301 (10) 873874875R (240) 912465
- Lot Number: 873874875R
What to Do
- Do not use Disposable Biopsy Needle Kits from the affected lot.
- If products from the affected lot are found, discard them.
On September 25, 2024, Elekta sent all affected customers an Urgent Important Field Safety Notification recommending the following actions:
- Remove all affected Disposable Biopsy Needles (911933) from clinical use.
- Dispose of products from the affected batch.
- Contact local Elekta representatives for alternative solutions.
- Post this notice for all users.
- Make sure all appropriate personnel are aware of this notice.
Reason for Recall
Elekta is recalling the Disposable Biopsy Needle Kit used with the Leksell Stereotactic System due to a risk for microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, the same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected.
The use of affected product may cause serious adverse health consequences, including debris entering the brain tissue and death.
There have been no reported injuries and no reports of death.
Device Use
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 at a target location in the brain.
Contact Information
Customers in the United States with questions about this recall should contact their Elekta local representative.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
