Z-0312-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2024
- Initiation Date
- October 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 packs of 5ea (40 total)
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.
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.
Distribution Pattern
Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
Code Information
Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517