News | FDA | April 29, 2024

Elekta Instrument AB recalls disposable biopsy needle kit for Leksell Stereotactic System for possibly containing microscopic stainless steel debris on the inside of the biopsy needle

Elekta Instrument AB recalls disposable biopsy needle kit for Leksell Stereotactic System for possibly containing microscopic stainless steel febris on the inside of the biopsy needle

April 29, 2024 — The U.S. Food and Drug Administration (FDA) announced Elekta Instrument AB is recalling Disposable Biopsy Needles (911933) from one batch (837838839) which can contain some microscopic stainless steel debris on the inside of the biopsy needle. The presence of debris in biopsy samples can hinder examination and delay the process. Moreover, there's a risk of debris being deposited in the brain, which could affect future MRI scans, potentially rendering them useless or unobtainable.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Product Names: Disposable Biopsy Needles (911933)
  • Product Codes: HAW
  • Lot Number: 837838839
  • Distribution Dates: August 29, 2023 to January 5, 2024
  • Devices Recalled in the U.S.: 10
  • Date Initiated by Firm: March 15, 2024

Device Use

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.

Reason for Recall

Elekta Instrument AB is recalling Disposable Biopsy Needles (911933) from one batch (837838839) which can contain some microscopic stainless steel debris on the inside of the biopsy needle. The material in the debris is stainless steel, the same material as the biopsy needle.

If debris on the inside of the biopsy needle comes loose, it may appear in the biopsy sample and delay or make examination difficult. There is also a potential risk of debris being deposited in the brain. The long term functional consequences of such particles in the brain are unknown. If this occurs, the metallic debris could cause future MRI scans of the brain to be useless or even 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.

There have been no reported injuries and no reports of death associated with this issue.

Who May be Affected

  • Health care professionals, specifically specialists in brain disorders, who use the Disposable Biopsy Needle Kit and Leksell Stereotactic System
  • People receiving care using the Disposable Biopsy Needle Kit and Leksell Stereotactic System

What to Do

On March 15, 2024, Elekta sent all affected customers an Urgent Recall Notification.

The letter requested customers to:

  • Remove and dispose all Disposable Biopsy Needles (911933) from batch 837838839.
    • Contact the local Elekta representative for ordering replacement needle kits.
  • Post this notice in a place accessible to all users and advise appropriate personnel.
  • Complete the included Acknowledge Form and return it to Elekta.

Contact Information

Customers in the U.S. with questions about this recall should contact Elekta Instrument AB at (855) 693-5358.

Additional Resources

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 using an online form, regular mail, or FAX.


Related Content

News | Radiation Therapy

June 19, 2024 — RaySearch Laboratories AB announced a milestone in radiotherapy technology where RaySearch’s RayStation ...

Time June 19, 2024
arrow
News | Mobile C-Arms

June 19, 2024 —Royal Philips, a global leader in health technology, today announced the launch of Philips Image Guided ...

Time June 19, 2024
arrow
News | Artificial Intelligence

June 17, 2024 — Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care ...

Time June 17, 2024
arrow
News | Proton Therapy

June 14, 2024 — Atlantic Health System, an integrated health care system setting standards for quality health care in ...

Time June 14, 2024
arrow
News | PET Imaging

June 14, 2024 — Positron Corporation, a leading molecular imaging medical device company offering PET and PET-CT ...

Time June 14, 2024
arrow
News | MRI Breast

June 12, 2024 — Royal Philips recently announced the 1,111th installation of its revolutionary BlueSeal 1.5T magnet ...

Time June 12, 2024
arrow
News | FDA

June 10, 2024 — Siemens Healthineers announces the Food and Drug Administration clearance of the Biograph Trinion, a ...

Time June 10, 2024
arrow
News | Breast Imaging

June 7, 2024 — Scholars and studies funded by Susan G. Komen(R), the world’s leading breast cancer organization ...

Time June 07, 2024
arrow
News | Radiopharmaceuticals and Tracers

June 7, 2024 — Shine Technologies, LLC, a pioneer in next-generation fusion-based technology, today announced a new ...

Time June 07, 2024
arrow
News | Information Technology

June 4, 2024 — International medical imaging IT and cybersecurity company Sectra has launched a new diagnostic IT module ...

Time June 04, 2024
arrow
Subscribe Now