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.
FDA Recall Z-0312-2025 · Posted 2024-11-08
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Recalling FirmFHC, Inc.
Recall StatusOpen, Classified
Product CodeHAW
Date Initiated2024-10-04
Product Quantity8 packs of 5ea (40 total)
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.
Firm Action
On October 4, 2024, the firm notified affected consignees via Urgent Medical Device Recall letters.
Customers were instructed to immediately identify and quarantine all affected product. The firm will contact customers and issue an RMA to return affected product and issue a replacement by 10/11/24. Customers should not use the product in the interim.
Should you have any further questions regarding this matter you may contact the firm by email at [email protected]
or by telephone at 207-666-5425.
Root Cause
Process change control
Distribution Pattern
Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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