IndigoRecalls & reported problems across all models

We found 6 models of Indigo by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 916 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2016 and Sep 25, 2026 — classified as 4 injuries, 912 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (836 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Indigo problems

Indigo models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Indigo™ 1845000

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  416 reports
• Indigo™ 1845000

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  165 reports
• Indigo™ 1845020

  ARTHROSCOPE
  152 reports
• Indigo 1845020

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  105 reports
• Indigo™ 1845010

  DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
  45 reports
• Indigo 1845010

  DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  33 reports

Recent Indigo adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 11, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205867 ↗
• 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 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 ↗
• 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 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 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 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 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 ↗
• MalfunctionApr 13, 2026Overheating of Device

  IT WAS REPORTED THAT THE INDIGO ATTACHMENT AND HANDPIECE WERE OVERHEATING. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEI VED STATING THAT THE EVENT OCCURRED DURING USE, AND OVERHEATING OCCURRED WHEN DEVICE WAS RUN FOR MORE THAN A MINUTE WHICH MAKES THE EVENT NOT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854447 ↗

Other Medtronic Xomed, Inc. products

• NIM Vital9 models · 1,696 reports · 4 recalls
• NIM-Response13 models · 974 reports
• NIM TriVantage18 models · 541 reports · 2 recalls
• StraightShot6 models · 546 reports
• NIM15 models · 410 reports · 2 recalls
• ViSAO16 models · 412 reports
• XPS Straightshot2 models · 356 reports
• RAD29 models · 183 reports · 1 recall