Indigo 1845020Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00763000172879), received between Jan 3, 2020 and Feb 23, 2026 — classified as 105 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (93 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 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Overheating of Device; Vibration

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE THE INDIGO DRILL HANDPIECE AND ATTACHMENT INTERRUPTS THE DRILL'S OPERATION (JERKS) AND CAUSES THE DRIVE TO HEAT UP SIGNIFICANTLY. THE HANDPIECE WAS USED LESS THAN A MINUTE, WHEN THE OVERHEATING WAS NOTICED. THE DEVICE WAS RUN AT 52000 RPM IN STANDARD MODE AND IRRIGATION WAS BEING USED. THE OVERHEATING WAS CAUSED POSSIBLY BY DRILL HANDPIECE AND ATTACHMENT. THE VIBRATING DEVICE WAS NOT USED ON THE PATIENT. THE ANGLE ATTACHMENT WAS PROBABLY CAUSED THE BLADE/BUR TO WOBBLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412009 ↗
• MalfunctionFeb 19, 2026Overheating of Device

  IT WAS REPORTED THAT TIGHTENING THE PARTS BY HAND ON HANDPIECE WAS EXTREMELY DIFFICULT AND THE DEVICES OVERHEATS. THERE WAS NO PATIENT IMPACT. POST EVENT HANDPIECE WAS RETESTED BY CUSTOMER AND THERE WAS NO FAULT FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386761 ↗
• MalfunctionJan 22, 2026Overheating of Device; Mechanical Jam

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE HEATS UP UP AFTER A MINUTE OF BEING USED. IRRIGATION WAS IN USE, AT THE FLOW RATE REQUESTED BY THE SURGEON. THE FLOW RATE IS VARIABLE. THE DEVICE WAS USED IN THE AUTOMATIC MODE AT PROGRAMMED SPEED. THERE WA SNO PATIENT IMPACT.

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

  MAUDE report 24151000 ↗
• MalfunctionJan 9, 2026Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT WAS OVERHEATING AND ROTATE PROBLEM. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017662 ↗
• MalfunctionOct 15, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  THE PRE-REPAIR TEMPERATURE TEST RESULTS OF THE INDIGO ATTACHMENT AFTER ONE MINUTE WERE 81 FAHRENHEIT (ANGLE), 80 FAHRENHEIT (BASE) AND 79 FAHRENHEIT (DISTAL BEARING). ALL THE TEMPERATURES RECORDED WERE LESS THAN 118 FAHRENHEIT. THEREFORE, THIS NO LONGER MEETS THE REPORTING CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276552 ↗
• MalfunctionSep 8, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD BEEN ONE-WAY ROTATION AND OVERHEATING WAS IDENTIFIED WITHIN ONE MINUTE. NO IRRIGATION WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991488 ↗
• MalfunctionAug 29, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PRE OP THE INDIGO ATTACHMENT WAS OVERHEATING IN LESS THAN A MINUTE AND LOCKING ISSUE. THE INDIGO DRILL WAS WORKING FINE WITH ANOTHER INDIGO ATTACHMENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920199 ↗
• MalfunctionAug 28, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT BEFORE OPERATION, THE DEVICE HAD EXCESSIVE HEAT LESS THAN A MINUTE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910371 ↗
• MalfunctionAug 25, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891931 ↗
• MalfunctionJul 14, 2025Overheating of Device; Vibration; Overheating of Device; Vibration

  IT WAS REPORTED THAT THE INDIGO ATTACHMENT WAS OVERHEATING AND CAUSING BLADE TO VIBRATE. PROCEDURE WAS COMPLETED WITH OTHER ATTACHMENTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492546 ↗
• MalfunctionJul 4, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT INDIGO ATTACHMENT WAS OVERHEATING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402750 ↗
• MalfunctionJun 25, 2025Overheating of Device; Complete Loss of Power; Overheating of Device; Complete Loss of Power

  IT WAS REPORTED THAT DURING SET UP THE INDIGO ATTACHMENT WAS NOT TURNING ON AND HEATING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326488 ↗
• MalfunctionMay 30, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111849 ↗
• MalfunctionApr 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USE, ATTACHMENT WAS NOT LOCKING IN. THE BUR WOBBLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNIT. THE ATTACHMENT WAS VIBRATING CAUSING BUR TO VIBRATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916523 ↗
• MalfunctionMar 28, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE INDIGO ATTACHMENT OVERHEATING HALFWAY THROUGH PROCEDURE. REQUIRING OPENING NEW SET HALFWAY THROUGH THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21716567 ↗
• MalfunctionMar 11, 2025Overheating of Device; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED THAT ,THE DEVICE WAS RUNNING IN FORWARD MODE AT 60000 RPM AND NO IRRIGATION BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574604 ↗
• MalfunctionFeb 11, 2025Overheating of Device; Connection Problem; Overheating of Device; Connection Problem

  THE PRE-REPAIR TEMPERATURE TEST RESULTS OF THE DEVICE SHOWED THAT WHEN OPERATED FOR 1 MINUTE, THE TEMPERATURE AT THE ANGLE WAS 78°F, AT THE BASE WAS 79°F, AND AT THE DISTAL BEARING WAS 77°F, ALL OF WHICH ARE BELOW 118.4°F WHICH MAKES THE EVENT NOT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357959 ↗
• MalfunctionFeb 10, 2025Vibration; Vibration

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING AND WOBBLING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342550 ↗
• MalfunctionFeb 9, 2025Vibration; Vibration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341309 ↗
• MalfunctionFeb 6, 2025Vibration; Vibration

  IT WAS REPORTED THE BEFORE OPERATION, THE BUR WOBBLES IN INDIGO ATTACHMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21320566 ↗
• MalfunctionFeb 6, 2025Vibration; Vibration

  IT WAS REPORTED THAT BEFORE OPERATION, THE BUR WOBBLES IN INDIGO ATTACHMENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319935 ↗
• MalfunctionFeb 6, 2025Vibration; Vibration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319619 ↗
• MalfunctionFeb 6, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE THE ATTACHMENT GETS HOT WITHIN 1 MINUTE. SPEED AT WHICH THE UNIT STARTS UP WAS 65000 RPM, FWD MODE WITH 15CC IRRIGATION FLOWRATE. WHEN TESTED WITH OTHER ATTACHMENTS, HANDPIECE DID NOT GET HOT WITH OTHER ATTACHMENTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319172 ↗
• MalfunctionFeb 3, 2025Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290708 ↗
• MalfunctionJan 31, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRE-OP, THE INDIGO ATTACHMENT HAS EXCESSIVE HEAT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282436 ↗

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: