FHC Issues Recall for microTargeting Insertion Tube Sets Due to Manufacturing Size Issue That Poses Potential Risk to Patients

FHC Issues Recall for microTargeting Insertion Tube Sets Due to Manufacturing Size Issue That Poses Potential Risk to Patients

FHC Issues Recall for microTargeting Insertion Tube Sets Due to Manufacturing Size Issue That Poses Potential Risk to Patients

This recall pertains to the removal of certain medical devices from their usage locations or sales points. The FDA has classified this recall as the most critical category, as continued use may lead to severe injury or fatality.

Product Information 

microTargeting Insertion Tube Set with affected lot number
  • Product Names: microTargeting Insertion Tube Set 
  • Unique Device Identifier (UDI)/Model: 10873263004323/66-IT-05P 
  • Lot Number: 244517

Recommended Actions  

  • Refrain from using any microTargeting Insertion Tube Sets from the specified lot.  

On October 3, 2024, FHC Inc. dispatched an Urgent Medical Device Recall letter to all impacted customers advocating the following steps: 

  • Promptly identify and isolate all affected products.
  • Anticipate communication from FHC Inc. representatives via email or phone; they will issue an RMA for returning the affected products and arrange for replacements by 10/11/2024.
  • Do not utilize the affected products during this period. 

Recall Justification

The recall of microTargeting Insertion Tube Sets by FHC Inc. is prompted by a manufacturing error that resulted in the reducing cannula in the units being 20 mm longer than intended. 

Using the affected products poses a risk of severe health complications, which may include hemorrhaging, brain tissue damage, or even mortality. 

So far, no injuries or fatalities have been reported.

Intended Use of the Device 

These FHC microTargeting Insertion Tube Sets are designed to accurately direct a microelectrode or instrument in the brain during targeted functional brain surgeries (neurosurgery).

Customer Support

US customers with inquiries concerning this recall can reach out to FHC Inc. at 207-666-8190. 

Additional Resources from the FDA

Unique Device Identifier (UDI) 

The unique device identifier (UDI) is established to track individual medical devices marketed in the United States from production to patient application. It facilitates more accurate reporting and analysis of adverse event data, allowing for quicker identification and resolution of issues with devices. 

Reporting Issues

Healthcare professionals and consumers can report any adverse effects or quality issues they encounter while using these devices to MedWatch, the FDA’s program for safety information and adverse event reporting.