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.
