Device 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.
Z-0312-2025
Product summary
- Firm
- FHC, Inc.
- Event
- Event 95479
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 8 packs of 5ea (40 total)
- Official record key
device-enforcement:Z-0312-2025
Official wording
Reason: 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.
Code information: Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
Distribution pattern: Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
Derived failure modes
-
Unknown
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.