This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
- Product Names: microTargeting Insertion Tube Set
- Unique Device Identifier (UDI)/Product Model: 10873263004323/66-IT-05P
- Lot Number: 244517
What to Do
- Do not use microTargeting Insertion Tube Sets from the affected lot.
On October 3, 2024, FHC Inc. sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
- Immediately identify and quarantine all affected product.
- Expect contact from FHC Inc. field representatives by email/phone. They will issue an RMA for return of affected product and issue replacements by 10/11/2024.
- Do not use affected product in the interim.
Reason for Recall
FHC Inc. is recalling microTargeting Insertion Tube Sets from a specific product lot after a manufacturing error caused the reducing cannula in these sets to be 20 mm longer than specified.
The use of affected product may cause serious adverse health consequences, including bleeding (hemorrhage), damage to brain tissue, and death.
There have been no reported injuries. There have been no reports of death.
Device Use
FHC microTargeting Insertion Tube Sets are used to accurately guide a microelectrode or instrument in the brain during targeted, functional brain surgery (neurosurgery).
Contact Information
Customers in the United States with questions about this recall should contact FHC Inc. at 207-666-8190.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
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.
