Elekta Issues Recall on Biopsy Needle Kits: Concerns Over Potential Microscopic Stainless Steel Contaminants Found Inside Disposable Needles

Elekta Issues Recall on Biopsy Needle Kits: Concerns Over Potential Microscopic Stainless Steel Contaminants Found Inside Disposable Needles

Elekta Issues Recall on Biopsy Needle Kits: Concerns Over Potential Microscopic Stainless Steel Contaminants Found Inside Disposable Needles

The recall pertains to the withdrawal of specific medical devices from market and usage. This recall is classified by the FDA as the most significant category, as continuing to use the affected device may result in severe injury or even death.

Product Details

  • Product Name: Elekta Disposable Biopsy Needle Kit
  • Unique Device Identifier (UDI):
    • Package containing 6 needles: (01)0 7340048 30034 6 (17) 260401 (10) 873874875R (240) 911933
    • Package containing 1 needle: (01)0 7340048 30800 7 (17) 260301 (10) 873874875R (240) 911761
    • Inner sterile bag with 1 needle: (01)0 7340048 30801 4 (17) 260301 (10) 873874875R (240) 912465
  • Lot Number: 873874875R

Recommended Actions

  • Cease using Disposable Biopsy Needle Kits from the specified lot.
  • If any affected products are located, eliminate them properly.

On September 25, 2024, Elekta issued an Urgent Important Field Safety Notification to all impacted customers advising them of the following steps:

  • Withdraw all affected Disposable Biopsy Needles (911933) from medical use.
  • Dispose of items from the identified lot.
  • Reach out to local Elekta representatives for alternative options.
  • Display this notice for all applicable users.
  • Ensure that all relevant personnel are informed of the notification.

Reason for Recall

Elekta is issuing a recall for the Disposable Biopsy Needle Kit utilized with the Leksell Stereotactic System due to concerns regarding microscopic fragments within the biopsy needle. The debris consists of stainless steel, identical to the material used for the biopsy needle, with no contaminants detected on the outer portions of the needle, and the sterility remains intact.

The use of the impacted product may lead to serious health consequences, including the potential for debris to enter brain tissue and result in fatality.

No injuries or fatal incidents have been reported to date.

Device Application

The Disposable Biopsy Needle Kit is employed in neurosurgery for the accurate sampling of brain tissue. It is specifically crafted for use with the Leksell Stereotactic System, enabling surgeons to precisely obtain tissue samples from targeted areas within the brain.

Contact Information

U.S. customers with inquiries regarding this recall should reach out to their local Elekta representative.

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) is critical for tracking individual medical devices sold in the U.S. from their manufacture to patient use. This system enhances the accuracy of reporting, reviewing, and analyzing adverse event reports, facilitating faster identification of devices and potential issue resolution.

Reporting Issues

Healthcare professionals and consumers can report adverse reactions or quality concerns they have encountered with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.