FDA issues Class I recall on insertion tubes after manufacturing error

The U.S. Food and Drug Administration (FDA) is notifying clinicians and medical supply houses about a recall on insertion tubes, used to guide a microelectrode in the brain during targeted brain surgery. These microTargeting Insertion Tube Sets, sold by FHC, are 20mm too long due to a manufacturing error and could put patients at serious risk for injury or death. 

While there have been no reported injuries, this recall has been designated a Class I, the most serious type. 

What is being recalled?

Insertion tubes from FHC that match the below details are subject to the recall and should be quarantined immediately

  • Product Name: microTargeting Insertion Tube Set 
  • Lot Number: 244517
  • Unique Device Identifier (UDI): 10873263004323/66-IT-05P

Next Steps

FHC sent all known affected customers a letter on Oct. 3, notifying them of the manufacturing defect. Any customers with recalled needles will need to stop using them immediately. 

All customers should contact FHC at 207-666-8190 to acquire replacements. Until then, alternative insertion tubes will need to be used.

The full FDA recall notice can be found here.

Chad Van Alstin Health Imaging Health Exec

Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.

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