Indigo™ 1845020Recalls & reported problems
Medtronic Xomed, Inc. · ATTACHMENT 1845020 INDIGO OTOL ANGLED · Class 2
All models of Indigo (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Xomed Indigo angled attachment, used in arthroscopic surgery, has 152 adverse event reports, including 2 injuries (such as burns) and no deaths. Most describe the attachment or handpiece overheating, with some reporting vibration, crackling noise or jamming. Reports generally say there was no patient impact. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 152
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 00613994933690), received between Mar 23, 2017 and Apr 13, 2026 — classified as 2 injuries, 150 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (129 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device129
- Vibration22
- Connection Problem10
- Noise, Audible8
- Mechanical Problem6
- Use of Device Problem4
- Mechanical Jam3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions94
- No Consequences Or Impact To Patient38
- No Patient Involvement16
- No Known Impact Or Consequence To Patient3
- Burn(s)2
- Superficial (First Degree) Burn1
Recent adverse event reports
The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionFeb 19, 2026Overheating of Device; Noise, Audible
IT WAS REPORTED THAT DRILL HANDPIECE HEATING UP DURING USE AND A CRACKLING NOISE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387759 ↗MalfunctionDec 16, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE WAS EXCESSIVELY HEATING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816278 ↗MalfunctionDec 11, 2025Overheating of Device; Overheating of Device
ADDITIONAL INFORMATION RECEIVED,THE DEVICE OVERHEATING WAS NOTICED WHEN USED FOR MORE THAN A MINUTE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23775295 ↗MalfunctionSep 2, 2025Overheating of Device; Vibration; Overheating of Device; Vibration
IT WAS REPORTED THAT DURING SETUP, THE INDIGO ATTACHMENT GETS HOT AND VIBRATES WHILE IRRIGATION WAS IN USE. IT WAS OBSERVED THAT THE INDIGO ATTACHMENT CAUSED THE BLADE/BUR TO WOBBLE, BUT THE VIBRATING DEVICE WAS NOT USED ON A PATIENT. THE ISSUE WAS IDENTIFIED THAT THE COMPONENT VIBRATING WAS THE ATTACHMENT ITSELF. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937646 ↗MalfunctionAug 11, 2025Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam
IT WAS REPORTED THAT INTRA-OP, THE DRILL WAS OVERHEATING AND JAMMING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22777300 ↗MalfunctionJul 14, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT INDIGO ATTACHMENT WAS GETTING HOT AND THE PROCEDURE COULD BE COMPLETED WITH OTHER INDIGO ATTACHMENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22492151 ↗MalfunctionJul 14, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT INDIGO ATTACHMENT WAS HOT AND THE PROCEDURES COULD BE COMPLETED WITH OTHER ATTACHMENTS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22491379 ↗MalfunctionMay 24, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING USE, DRILL WAS OVERHEATING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081989 ↗MalfunctionMar 30, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PROCEDURE, CUTTER WAS VIBRATING WHEN USED WITH INDIGO ATTACHMENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21728539 ↗MalfunctionFeb 13, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE INDIGO ATTACHMENT WAS OVERHEATING AND DOES NOT DRILL. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21376658 ↗MalfunctionFeb 10, 2025Vibration; Vibration
IT WAS REPORTED THAT THE DRILL HANDPIECE STRIKES OUT. THE EVENT OCCURRED DURING SETUP, THE BLADE VIBRATES. THERE WAS NO PATIENT INVOLVEMENT SINCE THE ISSUE WAS FOUND PRIOR TO USE ON THE PATIENT DURING SETUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341698 ↗MalfunctionFeb 6, 2025Vibration; Vibration
IT WAS REPORTED THAT THERE WAS EXCESSIVE VIBRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21318966 ↗MalfunctionFeb 4, 2025Mechanical Problem; Vibration; Mechanical Problem; Vibration
IT WAS REPORTED THAT DURING MAINTENANCE, THE INDIGO ATTACHMENT WAS NOT WORKING PROPERLY, HANGING, VIBRATING, AND LEAKING OIL. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303242 ↗MalfunctionFeb 4, 2025Vibration; Vibration
IT WAS REPORTED THAT THE INDIGO ATTACHMENT HAD TOOL VIBRATION ISSUE DURING PRE-OPERATIVE. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21301806 ↗MalfunctionJan 13, 2025Vibration; Vibration
IT WAS REPORTED THAT THE INTRAOPERATIVELY, THE INDIGO ATTACHMENT WORKS BY FITS AND STARTS. THE BUR SHAKES. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21134601 ↗MalfunctionDec 4, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT PRE-OP, INDIGO ATTACHMENT HAD BEARINGS DAMAGED AND OVERHEATING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20842619 ↗MalfunctionOct 25, 2024Vibration; Vibration
IT WAS REPORTED THAT INTRAOPERATIVELY, THE INDIGO ATTACHMENT HAD AN ALLEGED DEFECT WITH NO CUSTOMER COMMENTS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20532381 ↗MalfunctionSep 24, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE WAS NOISY AND OVERHEATING . THERE WAS NO PATIENT IMPACT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20290830 ↗MalfunctionSep 10, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE INDIGO ATTACHMENT HAD A HEATING PROBLEM. THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20178003 ↗MalfunctionSep 6, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE INDIGO ATTACHMENT HAD HEATING PROBLEM. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20154467 ↗MalfunctionAug 20, 2024Mechanical Problem; Vibration; Noise, Audible; Mechanical Problem; Vibration; Noise, Audible
IT WAS REPORTED THAT THE INDIGO ATTACHMENT HAD SEVERAL PARTS LOOSE, SPRINGS WERE LOOSE AND IT RATTLES. THE DEVICE WAS NOISY AND WOBBLING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20002890 ↗MalfunctionAug 5, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT AFTER OPERATION, THE DEVICE HAD ISSUE OF EXCESSIVE HEAT UP IN ABOUT 1 MINUTE. THERE WAS NO PATIENT INVOLVED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19904330 ↗MalfunctionJul 8, 2024Break; Overheating of Device; Failure to Power Up; Break; Overheating of Device; Failure to Power Up
IT WAS REPORTED THAT THE INDIGO ATTACHMENT WAS EXTERNALLY DAMAGED OVERHEATING AND ONLY ROTATING AT A MAXIMUM OF 800 REVOLUTIONS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19687068 ↗MalfunctionJun 17, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING INTRA OP INDIGO ATTACHMENT WAS OVERHEATING IN LESS THAN A MINUTE. THE DEVICE WAS BEING RUN 52000 RPM IN FORWARD MODE. THE IRRIGATION WAS USED AT A FLOW RATE OF 15 CC. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19555110 ↗
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 · TerminatedSoftware 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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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