Indigo™ 1845010Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00613994933706), received between Jul 24, 2017 and Jan 5, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (34 reports).

1 other recall cover devices cleared under the same FDA submission (K081277); 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Vibration; Noise, Audible

  IT WAS REPORTED THAT DURING INTRA-OP THE INDIGO ATTACHMENT WAS RATTLING A LOT WHEN TURNING AND THERE WAS PLAY IN THE DRILL BIT. TRIED DRILL BIT WITH AN ANGLED ATTACHMENT AND HAD NO PROBLEMS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960770 ↗
• MalfunctionAug 6, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED DURING INTRA-OP THAT THE DEVICE HAD OVERHEATING AND JAMMED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724079 ↗
• MalfunctionJun 24, 2025Vibration; Vibration

  IT WAS REPORTED THAT THE BUR IS NOT STABLE IN THE INDIGO ATTACHMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312930 ↗
• MalfunctionMay 2, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT WAS HEATING. THE OVERHEATING WAS NOTICED WHEN USED FOR LESS THAN ONE MINUTE. IT WAS RUN AT A SPEED OF 60000 RPM IN FORWARD MODE WITH NO IRRIGATION BEING USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947827 ↗
• MalfunctionFeb 8, 2025Vibration; Vibration

  IT WAS REPORTED DURING INTRA-OP THAT ATTACHMENT NOT LOCKING PROPERLY AND THE BUR VIBRATING. PROCEDURE WAS COMPLETED WITH BACK-UP ATTACHMENT WITH SAME BUR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340337 ↗
• MalfunctionFeb 7, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT TOOL HAD BUBBLING ISSUE; THE BUR WAS VIBRATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332667 ↗
• MalfunctionFeb 5, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS VIBRATION OF BUR WHILE RUNNING, BEARING PROBLEM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318852 ↗
• MalfunctionJan 17, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY, INDIGO ATTACHMENT BEARINGS RUN ON THE DRILL GETS HOT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179747 ↗
• MalfunctionSep 9, 2024Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED STATING OVERHEATING WAS NOTICED WITHIN ONE MINUTE. THE DEVICE WAS RUN ON 60000RPM IN FORWARD MODE. IRRIGATION WITH WATER WAS USED WITH A FLOW RATE OF 50CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167323 ↗
• MalfunctionAug 8, 2024Vibration; Connection Problem; Vibration; Connection Problem

  IT WAS REPORTED THAT DURING USE, THE INDIGO ATTACHMENT WAS NOT HELD SECURELY AND WAS VIBRATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19936165 ↗
• MalfunctionAug 5, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT POST PROCEDURE INDIGO ATTACHMENT HAD EXCESS HEAT. IT WAS FURTHER STATED OVERHEATING WAS NOTICED ABOUT A MINUTE OF USING THE HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19903757 ↗
• MalfunctionApr 6, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, IT WAS FOUND THAT THE TOOL HAD ISSUE WITH ROTATION AND HEATING PROBLEM. THE OVERHEATING OCCURRED WITHIN A MINUTE AND THE DEVICE WAS BEING USED AT 60000 RPM IN FORWARD MODE WITH MANUAL IRRIGATION. THE DEVICE WAS NOT USED IN THE PROCEDURE AND A SEPARATE ATTACHMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056560 ↗
• MalfunctionMar 4, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INTRA-OP, INDIGO HANDPIECE AND ATTACHMENTS WERE OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825056 ↗
• MalfunctionFeb 23, 2024Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, BUR WAS WOBBLING WHEN USED WITH INDIGO ATTACHMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766160 ↗
• MalfunctionDec 26, 2023Vibration; Vibration

  ADDITIONAL INFORMATION RECEIVED THAT THE INDIGO ATTACHMENT ALSO VIBRATES WHILE USING. THE BUR HAVE BEEN INSERTED INTO DIFFERENT ATTACHMENT AND IT WORKED FINE. THE ATTACHMENT HAVE BEEN INSERTED INTO DIFFERENT BUR AND IT DOES NOT WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18391379 ↗
• MalfunctionJul 10, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO PROCEDURE INDIGO ATTACHMENT OVERHEAT. THE PROCEDURE WAS COMPLETED WITH BACKUP DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287155 ↗
• MalfunctionJul 10, 2023Overheating of Device; Vibration; Overheating of Device; Vibration

  IT WAS REPORTED THAT PRIOR TO PROCEDURE INDIGO ATTACHMENT OVERHEAT AND BUR WOBBLES. THE PROCEDURE WAS COMPLETED WITH BACK UP DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287152 ↗
• MalfunctionJun 2, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PREOPERATIVE, HANDPIECE WAS RUNNING IN FORWARD MODE AT 60000 RPM WITH MANUAL IRRIGATION. INDIGO ATTACHMENT HAD ROTATING ISSUE AND WAS HEATING WITH A MINUTE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17047275 ↗
• MalfunctionSep 27, 2022Vibration; Vibration

  IT WAS REPORTED THAT INDIGO ATTACHMENT HAD VIBRATIONS. NO PATIENT OR STAFF IMPACT. EVENT OCCURRED DURING OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492389 ↗
• MalfunctionJun 28, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED BY HCP THAT DURING OP THE DEVICE WAS OVERHEATING. THERE WAS NO PATIENT/STAFF IMPACT. UPON FOLLOW UP, ADDITIONAL INFORMATION RECEIVED SUGGESTS THAT PROCEDURE WAS COMPLETED USING BACKUP PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840924 ↗
• MalfunctionMay 16, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS GETTING OVERHEAT PRIOR TO USE .NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14414183 ↗
• MalfunctionMay 12, 2022Overheating of Device; Overheating of Device

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT PRIOR TO USE, THE DEVICE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14378696 ↗
• MalfunctionMar 10, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE OVERHEATS DURING USE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13718146 ↗
• MalfunctionDec 20, 2021Overheating of Device; Overheating of Device

  A MANUFACTURER REPRESENTATIVE REPORTED THAT THE ATTACHMENT WAS SLIGHTLY HEATING PRIOR TO THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042152 ↗
• MalfunctionSep 17, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488412 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081277. 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