microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot… recallZ-0312-2025 · FHC, Inc. · initiated Oct 4, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from FHC, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-0312-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 4, 2024
- Posted by the FDA
- Nov 8, 2024
- Recalling firm
- FHC, Inc.
- Quantity
- 8 packs of 5ea (40 total)
- Product code
- HAW
- FDA submissions
- K011775
- Distribution
- Domestic distribution only to the following states: AZ, CA, PA, TN, TX, WA.
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.
Code information (models, lots, serial numbers)
Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- microTargeting™ Insertion Tube Set 66-IT-05P-00432Fhc, Inc. · Neurological stereotaxic Instrument1 recall1 report
Other devices under the same FDA submission
5 devices cleared under K011775 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- microTargeting™ Drive System FC1006-00147Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Drive System MT-DS-01-00350Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Drive System MT-DS-00352Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Drive 66-ZD-MD-01-00356Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- microTargeting™ Drive 66-ZD-MD-00357Fhc, Inc. · Neurological stereotaxic Instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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