microTargeting™ Sterile Drape Sleeve 66-DA-SD-00436Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00873263004364), received between Jun 11, 2025 and Jun 11, 2025 — classified as 1 injury.

6 other recalls cover devices cleared under the same FDA submission (K011992); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 FHC OPENED A RECORD IN OUR QMS SYSTEM REGARDING A PRODUCT RETURN ISSUE FROM CHILE. DURING INVESTIGATION INTO THIS ISSUE, FHC DISCOVERED THAT OUR SALES REPS. IN LATIN AMERICA HAD REMOVED PRODUCTS FROM ONE DISTRIBUTOR IN CHILE AND PROVIDED TO A DIFFERENT CUSTOMER IN CHILE. SOME OF THE PRODUCTS REMOVED AND REDISTRIBUTED WERE STERILE. AS PER OUR QMS PROCEDURES, PRODUCTS ARE TO BE RETURNED TO OUR HEADQUARTERS (ME, USA) FOR REINSPECTION PRIOR TO ANY ADDITIONAL DISTRIBUTION ACTIVITIES. SOME OF THE PRODUCTS REDISTRIBUTED WERE USED IN SURGERIES. THERE WERE NO ADVERSE EVENTS AS A RESULT OF USE. THIS REPORT IS BEING GENERATED AS THERE WAS A POTENTIAL OF RISK SINCE THE PRODUCT WAS NOT REINSPECTED, STERILITY COULD HAVE BEEN COMPROMISED AND COULD HAVE RESULTED IN AN INFECTION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22185419 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011992. One submission often covers many models, so check the product and lot details in each record.

• Z-2353-2018 · May 10, 2018 · Terminated
  microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
• Z-2359-2018 · May 10, 2018 · Terminated
  microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
• Z-0486-2009 · Oct 8, 2008 · Terminated
  FHC microTargeting Platform DBS Measuring Fixture, a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). The device is a stereotactic instrument used for the
• Z-0180-06 · Oct 31, 2005 · Terminated
  Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System with models: 9033G0711; 9033G0712; 9033G0713; 9033G0811 and FHC 1008-66
• Z-0179-06 · Oct 31, 2005 · Terminated
  FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS;66EL-MS-02; 66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD.
• Z-0895-05 · Mar 14, 2005 · Terminated
  FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)