Indigo™ 1845000 (UDI 00613994933713)Recalls & reported problems

Summary

The FDA's MAUDE database contains 416 adverse event reports that list this exact device (DI 00613994933713), received between Dec 6, 2016 and Sep 25, 2026 — classified as 2 injuries, 414 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (401 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 416 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Overheating of Device

  It was reported that pre-op, the indigo handpiece was overheated. There is no patient involved in this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894978 ↗
• MalfunctionSep 24, 2026Overheating of Device

  It was reported that before the operation, the indigo attachment and handpiece had excessive heat. There is no patient involved in this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877983 ↗
• MalfunctionSep 15, 2026Overheating of Device

  It was reported that during not in surgery the Indigo handpiece overheated. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767492 ↗
• MalfunctionJun 15, 2026Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT THAT EXCESSIVE OVERHEATING WAS NOTICED FOR THE INDIGO HANDPIECE AND ALSO THERE IS DIFFICULTY IN ANCHORING/UNANCHORING THE CUTTERS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503853 ↗
• MalfunctionMay 8, 2026Overheating of Device

  IT WAS REPORTED THAT DURING USE, THE INDIGO DRILL WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25121840 ↗
• MalfunctionApr 23, 2026Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT AND HANDPIECE WAS OVER HEATED WHEN USING LESS THAN A MINUTE OF USE AND NOT MOVING. THE HANDPIECE WAS USED IN THE FORWARD MODE WITH FLOW RATE OF 10 CC/MIN. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24962075 ↗
• MalfunctionApr 19, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS OVERHEATING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921371 ↗
• MalfunctionApr 13, 2026Overheating of Device

  IT WAS REPORTED THAT INDIGO DRILL WAS OVERHEATING WHILE IN USE. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24855954 ↗
• MalfunctionMar 30, 2026Overheating of Device; Connection Problem

  AS PER THE ANALYSIS OF THE HANDPIECE, THE PRE-REPAIR TEMPERATURES PERFORMED AT 1 MINUTE ARE LESS THAN 118F(WITHIN SPECIFICATION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725618 ↗
• MalfunctionFeb 24, 2026Overheating of Device

  IT WAS REPORTED THAT PREOPERATIVELY, THE DRILL WAS HAVING HEATING IN LESS THEN ONE MINUTE ISSUE, DRILL WAS RUNNING IN FORWARD MODE WITH IRRIGATION AT 30CC. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24438641 ↗
• MalfunctionFeb 20, 2026Overheating of Device

  IT WAS REPORTED PRIOR TO USE, THAT DRILL HANDPIECE HAD OVERHEATING ISSUE WITHIN A MINUTE. THE PROCEDURE WAS COMPLETED WITH THE BACK UP DEVICE. IRRIGATION WAS USED AND DEVICE WAS USED IN FORWARD DIRECTION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398066 ↗
• MalfunctionFeb 19, 2026Overheating of Device; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THE INDIGO HANDPIECE NO LONGER WORKS PROPERLY AND WAS OVERHEATING QUICKLY. IT GIVES AN ERROR CODE 15 ON THE IPC CONSOLE. THERE WAS NO KNOWN PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE EVENT OCCURRED DURING TESTING IN THE CUSTOMER'S WORKSHOP. THE DEVICE WAS OVERHEATING WITHIN A MINUTE, AND THE SPEED WAS FLUCTUATING WHEN SET TO MAXIMUM SPEED IN DEFAULT MODE. ADDITIONALLY, NO IRRIGATION WAS USED AND THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389783 ↗
• MalfunctionFeb 18, 2026Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT INDIGO DRILL HANDPIECE WAS HEATING UP DURING USE AND MAKE CRACKLING NOISE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24374704 ↗
• MalfunctionFeb 17, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE, THE MOTOR WAS MAKING EXCESSIVE NOISE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373947 ↗
• MalfunctionJan 30, 2026Overheating of Device

  IT WAS REPORTED THAT INTRA-OP, THE DRILL WAS OVERHEATING AND IRRIGATION WAS USED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220441 ↗
• MalfunctionJan 2, 2026Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE WAS OVERHEATING. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941215 ↗
• MalfunctionDec 11, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE EVENT OCCURRED DURING SET-UP, THE DRILL MOTOR WAS NOT WORKING, IT WAS NOT DETECTED BY THE CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776910 ↗
• MalfunctionDec 8, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739534 ↗
• MalfunctionNov 20, 2025Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED THAT THE EVENT OCCURRED PRIOR TO USE AND THE DEVICE HEATS MORE THAN A MINUTE. THE DEVICE BEING RUN AT 42000RPM IN A FORWARD MODE WITH A FLOW RATE OF 20CC/MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603343 ↗
• MalfunctionNov 18, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE HANDPIECE HAD OVERHEATING ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579656 ↗
• MalfunctionNov 5, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DEVICE SENT FOR PM. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473816 ↗
• MalfunctionOct 21, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345268 ↗
• MalfunctionSep 2, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PRE-OP, THE INDIGO DRILL AND ATTACHMENTS VERY HOT WHEN USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936143 ↗
• MalfunctionJul 15, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS EXCESSIVE HEAT FROM INDIGO DRILL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509196 ↗
• MalfunctionJul 14, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING USE, CONSOLE INDICATES THAT INDIGO DRILL IS NOT TURNING AND DRILL GETS HOT WITHIN A MINUTE AS SOON AS TURNED ON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491581 ↗

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