medical Class I Updated 2024-11-20

FHC, Inc. recalls microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, PA, TN, TX, WA
Lot/Code Info: Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
View official government recall

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