microTargeting™ Insertion Tube Set 66-IT-05P-00432Recalls & reported problems
Fhc, Inc. · microTargeting Single Electrode Insertion Tube Set, Sterile, for use with Stereotactic Frame. Contains: IT(BP5): Insertion Tube - 199mm tube length, 1.83mm od, 1.6mm id PT(BP5): Protective Tube - 1.47mm od, .99mm id · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00873263004326), received between Oct 3, 2024 and Oct 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
7 other recalls cover devices cleared under the same FDA submission (K011775); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 4, 2024Class IOpen, Classified
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.
Z-0312-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Defective Device1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Movement Disorder1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2024Defective Device; Manufacturing, Packaging or Shipping Problem; Defective Device; Manufacturing, Packaging or Shipping Problem
FHC TECHNICIAN RECEIVED A CALL ON THE EVENING OF 9/24/2024 FROM DR. (B)(6) FROM (B)(6) DURING A DBS SURGERY. DR. (B)(6) WAS UNABLE TO PERFORM MER RECORDINGS WITH HIS 66-IT-05P LOT#: 244517 BECAUSE THE REDUCING CANNULA WAS MUCH TOO LONG AND EXTENDED BEYOND THE LEAD INSERTION TUBE, PREVENTING MER (THE MICROELECTRODE NEVER CAME OUT OF THE REDUCING CANNULA). THE CASE WAS DELAYED SLIGHTLY WHILE SURGEON TRIED TO FIGURE OUT WHY HE COULDN'T GET THE MER SYSTEM TO RECORD. THE SURGEON OPENED A DIFFERENT LOT OF 66-IT-05P AND WAS ABLE TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS NO PATIENT INJURY.
Patient problems: Movement Disorder
MAUDE report 20362990 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K011775. One submission often covers many models, so check the product and lot details in each record.
- Z-2345-2018 · May 10, 2018 · TerminatedmicroTargeting" Drive System, Product Number MT-DS
- Z-2356-2018 · May 10, 2018 · TerminatedmicroTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
- Z-2348-2018 · May 10, 2018 · TerminatedmicroTargeting" Drive System, Product Number 66-ZD-MD-01
- Z-2355-2018 · May 10, 2018 · TerminatedmicroTargeting" Drive System Distributed by Medtronic, Product Number FC1006
- Z-2346-2018 · May 10, 2018 · TerminatedmicroTargeting" Drive System, Product Number MT-DS-01
- Z-2347-2018 · May 10, 2018 · TerminatedmicroTargeting" Drive System, Product Number 66-ZD-MD
- Z-0895-05 · Mar 14, 2005 · TerminatedFHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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