microTargeting Insertion Tube Set (FHC) – Spacer Tube Design Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
FHC, Inc.
Lot Codes / Batch Numbers
Package DI: 10873263004323, Contains DI Package: 00873263004326 LOT No. 244517
Products Sold
Package DI: 10873263004323; Contains DI Package: 00873263004326 LOT No. 244517
FHC, Inc. is recalling microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guid due to A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 kmoeykens@fh-co.com or by telephone at 207-666-5425.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, PA, TN, TX, WA
Page updated: Jan 10, 2026