FDAOctober 4, 2024device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

fhc

UPCs

1087326300432300873263004326

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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