Indigo 1845010Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00763000172862), received between Nov 9, 2019 and Feb 23, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (23 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT WAS HEATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411365 ↗
• MalfunctionSep 17, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT PRIOR TO USE, THE INDIGO ATTACHMENT WAS HEATING AND BUBBLING. THE DEVICE EXPERIENCED OVERHEATING IN LESS THAN ONE MINUTE. THE DEVICE WAS OPERATED IN FORWARD MODE WITH AN IRRIGATION FLOW RATE OF 30CC. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070021 ↗
• MalfunctionJul 22, 2025Vibration; Vibration

  IT WAS REPORTED THAT PREOPERATIVELY THE BUR WAS WOBBLING. WHEN BUR TRIED ON ANOTHER ATTACHMENT IT DID NOT WOBBLE. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562512 ↗
• MalfunctionFeb 10, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT BUR WOBBLES. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341987 ↗
• MalfunctionFeb 6, 2025Vibration; Vibration

  IT WAS REPORTED THAT THE ATTACHMENT WOBBLES. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319860 ↗
• MalfunctionFeb 4, 2025Vibration; Noise, Audible; Vibration; Noise, Audible

  IT WAS REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT WAS VIBRATING ERRATICALLY WHEN IN USE AND HIGH PITCH WHIRRING SOUND, TORQUE MIS-F IRING. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301091 ↗
• MalfunctionJan 7, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO PROCEDURE INDIGO ATTACHMENT HAD HEATING ISSUE. HANDPIECE WAS HEATING WITHIN ONE MINUTE. DEVICE WAS RUNNING ON THE SPEED OF 60000RPM IN FORWARD MODE AND MANUAL IRRIGATION WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093283 ↗
• MalfunctionDec 30, 2024Vibration; Vibration

  IT WAS REPORTED THAT BEFORE OPERATION, THE STRAIGHT BUR WAS WOBBLING. THE BUR WAS CHECKED WITH ANOTHER INDIGO ATTACHMENT AND IT DIDN'T WORKED FINE AND THE INDIGO ATTACHMENT WAS CHECKED WITH ANOTHER BUR AND IT DIDN'T WORKED FINE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21033053 ↗
• MalfunctionNov 18, 2024Overheating of Device; Vibration; Overheating of Device; Vibration

  IT WAS REPORTED THAT INTRA-OP, THE INDIGO ATTACHMENT WAS OVERHEATING AND SKIPPING. THE DEVICE WAS USED IN FORWARD MODE AND IRRIGATION WAS USED. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT ATTACHMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20708794 ↗
• MalfunctionNov 7, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PREOPERATIVELY, THE INDIGO ATTACHMENT WAS HEATING WITHIN 1 MINUTE OF USAGE. HANDPIECE WAS RUNNING AT 60000RPM AND FORWARD MODE. CUSTOMER WAS USING MANUAL IRRIGATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627058 ↗
• MalfunctionOct 28, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING INTRA-OP, THE ATTACHMENT, CABLE, AND HANDPIECE BECOMES HOT DURING USE AND TOO HOT TO HANDLE RESULTING IN THEM HAVING TO STOP THE SURGERY AND USE THE OTHER EQUIPMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20541911 ↗
• MalfunctionSep 9, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO PROCEDURE INDIGO ATTACHMENT HAD HEATING ISSUE. IT WAS FURTHER STATED OVERHEATING WAS NOTICED IN LESS THAN ONE MINUTE. THE DEVICE WAS OPERATED ON FORWARD MODE AT 60000RPM AND EXTERNAL IRRIGATION WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20166808 ↗
• MalfunctionAug 13, 2024Vibration; Vibration

  IT WAS REPORTED THAT BEFORE THE OPERATION, THE ATTACHMENT WAS WOBBLING AND THE BUR WHICH IS USED ALONG WITH THE INDIGO ATTACHMENT IS NOT WOBBLING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972186 ↗
• MalfunctionMay 17, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PRE-OP, THE INDIGO ATTACHMENT HAD SMOKE. THE SMOKE WAS DUE TO OVERHEATING. THE OVERHEATING WAS NOTICED IN LESS THAN ONE MINUTE. THERE WAS SMOKE WITH HANDPIECE EVEN WITHOUT ATTACHMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339249 ↗
• MalfunctionApr 30, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INDIGO MOTOR WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214486 ↗
• MalfunctionApr 2, 2024Overheating of Device; Physical Resistance/Sticking; Overheating of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT WAS HEATING AND THE TOOL WAS STUCK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19022680 ↗
• MalfunctionApr 2, 2024Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  A HEALTH CARE PROFESSIONAL REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT WAS HEATING AND THE TOOL WAS STUCK. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019518 ↗
• MalfunctionApr 2, 2024Overheating of Device; Difficult to Remove; Overheating of Device; Difficult to Remove

  ADDITIONAL INFORMATION RECEIVED STATING ATTACHMENT OVERHEATED WITHIN A MINUTE DURING TESTING WHEN RUNNING AT A SPEED OF 30000RPM IN FORWARD MODE AND NO IRRIGATION WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016910 ↗
• MalfunctionMar 12, 2024Vibration; Vibration

  IT WAS REPORTED THAT THE INDIGO ATTACHMENT VIBRATES DURING USE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18883838 ↗
• MalfunctionFeb 1, 2024Leak/Splash; Vibration; Mechanical Jam; Leak/Splash; Vibration; Mechanical Jam

  IT WAS REPORTED THAT DURING CHECK-UP, THE INDIGO ATTACHMENT WAS KEEP ON VIBRATING, HANDING AND OIL CAME OUT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18620704 ↗
• MalfunctionJan 24, 2024Vibration; Connection Problem; Vibration; Connection Problem

  IT WAS REPORTED THAT BLADE OR TOOL WAS WOBBLING AND NOT CONNECTING PROPERLY. EVENT OCCURED DURING DEMO OR INSTALLATION, NOT IN SURGERY. THERE IS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY. BURS WAS WOBBLING, SEVERAL BURS (BOTH DEMO AND BRAND NEW BUR) WAS CONNECTED, ALL BURS WERE WOBBLING, HANDPIECE AND ATTACHMENT WAS NOT WOBBLING, THERE WAS PROBLEM WITH THE ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569123 ↗
• MalfunctionDec 22, 2023Overheating of Device; Connection Problem; Overheating of Device; Connection Problem

  IT WAS REPORTED THAT DURING USE THE INDIGO ATTACHMENT WAS OVERHEATING AND BUR WAS NOT FITTING IN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381961 ↗
• MalfunctionSep 27, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INDIGO ATTACHMENT WAS GETTING WARM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17828546 ↗
• MalfunctionSep 18, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE INDIGO STRAIGHT ATTACHMENT WAS OVERHEATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763805 ↗
• MalfunctionMay 29, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PRE OP THE INDIGO ATTACHMENT HAD HEATING ISSUE. THE DEVICE WAS HEATING IN LESS THAN A MINUTE AND THE DEVICE BEING RUN AT 60000 RPM IN FORWARD MODE. THE IRRIGATION WAS USED WITH A FLOW RATE OF 50 CC PER MINUTE. THE PROCEDURE WAS COMPLETED WITH OUT DRILL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017387 ↗

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: