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.
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