Medical Device Recall: microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedure
FHC, Inc. · October 4, 2024
Reason for Recall
A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.
Product Description
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
Distribution
Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
States Affected
AZ, CA, PA, TN, TX, WA
Quantity Affected
8 packs of 5ea (40 total)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0312-2025
Status: ongoing
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