Indigo™ 1845000 (UDI 00643169882621)Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 00643169882621), received between Sep 25, 2019 and Aug 11, 2026 — classified as 165 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (156 reports).

3 other recalls cover devices cleared under the same FDA submission (K081475); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205867 ↗
• MalfunctionMay 21, 2026Overheating of Device; Connection Problem

  IT WAS REPORTED THAT PRE-OP, THE INDIGO DRILL OVERHEATS, THE OVERHEATING OCCURRED LESS THAN A MINUTE OF USE AND THE DEVICE WAS RUNNING AT MAXIMUM SPEED IN FORWARD MODE AND NO IRRIGATION WAS USED AND THE DEVICE DOES NOT RETAIL THE TOOL (DOES NOT STICK THE TILLER). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25237807 ↗
• MalfunctionApr 30, 2026Overheating of Device

  IT WAS REPORTED THAT DURING PRE OP THE DEVICE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043286 ↗
• MalfunctionApr 30, 2026Overheating of Device

  IT WAS REPORTED THAT POST-OP, THE INDIGO HANDPIECE HAD EXCESSIVE HEAT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25040328 ↗
• MalfunctionApr 30, 2026Overheating of Device

  IT WAS REPORTED THAT, THE INDIGO DRILL WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038894 ↗
• MalfunctionApr 17, 2026Overheating of Device

  IT WAS REPORTED THAT DURING OPERATION, THE INDIGO HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908010 ↗
• MalfunctionApr 6, 2026Overheating of Device

  IT WAS REPORTED THAT THE INDIGO HANDPIECE WAS HEATING. PROCEDURE WAS COMPLETED WITH DEVICE, BUT IT TOOK TIME FOR COOL DOWN HANDPIECE. THE DEVICE WAS BEING RUN AT 52000 -60000 RPMS IN THE FORWARD MODE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788070 ↗
• MalfunctionApr 5, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE OVERHEATS LESS THAN A MINUTE. THE DEVICE WAS BEING RUN IN FORWARD MODE AT 30CC FLOW RATE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787174 ↗
• MalfunctionMar 31, 2026No Apparent Adverse Event

  THE DEVICE IS RETURNED FOR PLANNED MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739639 ↗
• MalfunctionMar 30, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE MOTOR WAS HEATING LESS THAN 3 MIN WORKING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725710 ↗
• MalfunctionMar 30, 2026Overheating of Device

  IT WAS REPORTED THAT PREOPERATIVE, HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710018 ↗
• MalfunctionMar 26, 2026Overheating of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRE-OP, THE SYSTEM EXPERIENCED OVERHEATING AND FREEZES DURING USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697449 ↗
• MalfunctionMar 20, 2026Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE INDIGO DRILL WAS OVERHEATING, THE DEVICE WAS RUNNING LESS THAN A MINUTE, AT THE SPEED 6000RPM, NO IRRIGATION WAS USED. THE INDIGO ATTACHMENT AND THE BLADE/BUR WERE WORKING FINE WITHOUT ANY ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646600 ↗
• MalfunctionMar 12, 2026Overheating of Device

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE HEATED EXCESSIVELY IN LESS THAN ONE MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586897 ↗
• MalfunctionFeb 25, 2026Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING. NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24438894 ↗
• MalfunctionFeb 22, 2026Overheating of Device

  IT WAS REPORTED THAT DURING PRE-OP, THE HANDPIECE HEATS UP WITHOUT ACCESSORIES AND LOAD. THE OVERHEATING WAS OBSERVED IN LESS THAN 1 MINUTE. THE BACKUP COLD INSTRUMENTS WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RUN AT 52K RPM IN STANDARD MODE. THE IRRIGATION WAS USED DURING THE PROCEDURE. THE ATTACHMENT BEARING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411026 ↗
• MalfunctionFeb 6, 2026Overheating of Device

  IT WAS REPORTED THAT THE INDIGO DRILL WAS OVERHEATING. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275416 ↗
• MalfunctionDec 20, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, THE DRILL CABLE WITH DRILL RUNNING HOT ON SYSTEM. IT WAS NOT POSSIBLE TO PLACE THE ATTACHMENT ON THE INDIGO HANDPIECE AND TO LOCK IT. ANOTHER SET WAS USED TO PROCEED WITH THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860065 ↗
• MalfunctionDec 17, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT HANDPIECE HAD OVERHEATING ISSUE. THERE WAS NO PATIENT IMPACT. THE EVENT OCCURRED DURING INTRA-OPERATION; HEATING OCCURRED IN LESS THAN A MINUTE. THE DEVICE WAS RUNNING AT 60K PER MINUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825780 ↗
• MalfunctionDec 8, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE INDIGO DRILL HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741526 ↗
• MalfunctionNov 17, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566159 ↗
• MalfunctionNov 4, 2025Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED, EVENT OCCURRED DURING INTRA-OP AND END PIECE APPEARED TO OVERHEAT. THE EVENT OCCURRED DURING INTRA-OP; THE DEVICE BEING RUN AT 52000 RPM AND IN FWD MODE. IRRIGATION BEING USED AT15 CC/MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462333 ↗
• MalfunctionNov 4, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE OP, THE INDIGO HANDPIECE WAS USED LESS THAN ONE MINUTE WHEN THE OVERHEATING WAS NOTICED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460713 ↗
• MalfunctionOct 28, 2025Overheating of Device; Incorrect, Inadequate or Imprecise Result or Readings; Overheating of Device; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING SET UP, DRILL HAD OVERHEATING ISSUE AND DOES NOT GO INSIDE AS THERE IS SOMETHING BLOCKING INSIDE. THE DEVICE OVERHEATED IN LESS THAN A MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400556 ↗
• MalfunctionOct 24, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING INTRA-OP, HANDPIECE WAS OVERHEATING AND THE ATTACHMENT WAS NOT SEATING PROPERLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377180 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081475. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E
• Z-0158-2022 · Aug 31, 2021 · Open, Classified
  Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with
• Z-2085-2016 · May 13, 2016 · Terminated
  Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: