autoLog IQ™ ATLGIQRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00643169982864), received between Feb 17, 2023 and Sep 2, 2026 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (21 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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566970 ↗
• MalfunctionAug 28, 2026Optical Problem; Noise, Audible

  Medtronic received information that during use of an Autolog IQ instrument, it was reported that it sent clear, translucent blood to the return bag. The instrument was replaced to complete the procedure. There was no adverse patient effect associated with this event. Medtronic received additional information that customer noted loud noises starting up. Medtronic received additional information that there were no visible or audible abnormalities with the unit. The issue with the unit was the optics fell out of specifications and this is a common issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497866 ↗
• MalfunctionAug 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50174112 ↗
• MalfunctionDec 14, 2025Optical Problem; Optical Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS AUTOLOG IQ INSTRUMENT SENT BLOOD DIRECTLY TO THE WASTE BAG. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799577 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT IT WAS SPILLING RED CELLS TO WASTE BAG. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23567314 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS AUTOLOG IQ INSTRUMENT WAS NOT SAVING BLOOD AND WAS LETTING IT ALL SPILL INTO THE WASTE BAG.THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23508625 ↗
• MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT BLOOD LEAKED FROM THE BOWL INTO THE CENTRIFUGE. IT WAS NOT A LOT OF BLOOD, BUT CUSTOMER DECIDED TO CHANGE DISPOSABLES. THE INITIAL DISPOSABLE WAS DISCARDED AND IS NOT AVAILABLE. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE AUTOLOG IQ INSTRUMENT WAS NOT REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT BLOOD LOSS DUE TO THE LEAK WAS MINIMAL, NOT MEASURED BY THE CUSTOMER. NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794253 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Optical Problem; Fluid/Blood Leak; Optical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOGIQ INSTRUMENT, IT WAS REPORTED THAT A SENSOR ISSUE WITH THE CELL SAVER #101 - IT DID NOT NOTICE THAT THE BOWL WAS FULL AND WAS SPILLING RED BLOOD CELLS (RBCS) INTO THE WASTE BAG. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375932 ↗
• MalfunctionJun 13, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF THE AUTOLOG IQ INSTRUMENT, BLOOD WENT INTO THE WASTE BAG AND DID NOT GO INTO THE WASH PORTION. THE INSTRUMENT WAS REPLACED. THERE WERE NO COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201264 ↗
• MalfunctionJun 4, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE CUSTOMER FOUND RED CELLS SPILLI NG INTO WASTE BAG WHEN THEY THOUGHT IT SHOULD HAVE SWITCHED TO WASH MODE, BUT THE OPERATOR MANUALLY TRIGGERED TO WASH MODE. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142589 ↗
• MalfunctionMay 26, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THIS UNIT WILL NOT TRANSFER TO BOWL AND WILL NOT WASH. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084533 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE HOLDING BAG FLUID LEAKED INTO THE RESERVOIR. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019136 ↗
• MalfunctionMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT IT WAS LEAKING BLOOD INTO THE SALINE BAG. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011636 ↗
• MalfunctionMay 2, 2025Optical Problem; Optical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT WAS PULLING BLOOD INTO THE WASHING BAG WHEN PROCESSING. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SALINE BAG IS THE WASHING BAG AND BLOOD WAS SENT TO IT. THERE WAS NO DAMAGE NOTED IN THE INSTRUMENT OR THE DISPOSABLE AND NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES. THERE WAS NO ERROR ALARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948839 ↗
• MalfunctionMay 2, 2025Optical Problem; Optical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT WAS LEAKING BLOOD BACK INTO THE HOLDING BAG WITHOUT PROCESSING. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO DAMAGE WAS NOTED IN THE INSTRUMENT OR THE DISPOSABLE AND THERE WAS NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES. NO ERROR WARNING MESSAGE APPEARED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21948387 ↗
• MalfunctionMar 27, 2025Optical Problem; Optical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE BLOOD WAS GOING DIRECTLY INTO THE WASTE BAG. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708707 ↗
• MalfunctionMar 11, 2025Optical Problem; Optical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOGIQ INSTRUMENT, IT WAS REPORTED THAT RED BLOOD CELLS WERE BEING DIVERTED TO THE WASTE BAG. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573343 ↗
• MalfunctionFeb 9, 2025Optical Problem; Optical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT ALL BLOOD VOLUME WAS SENT TO THE WASTE BAG. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341109 ↗
• MalfunctionJan 22, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT A NOTE WAS FOUND ON THE UNIT STATING THAT FLUID HAD GONE TO THE BLOOD BAG INSTEAD OF THE RESERVOIR. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE FLUID WENT TO THE HOLDING BAG INSTEAD OF THE RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206595 ↗
• MalfunctionJan 22, 2025Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT WHILE PROCESSING BLOOD, IT SPILLED INTO WASTE BAG AND WAS NOT DETECTED. THE UNIT WAS REMOVED FROM USE. THIS WAS THE FIRST USE OF THE UNIT SINCE BEING UNBOXED. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206540 ↗
• MalfunctionJan 20, 2025Optical Problem; Optical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE UNIT WAS SENDING GOOD BLOOD TO THE WASTE BAG. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190493 ↗
• MalfunctionJan 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE BOWL WAS OVER FILLING DURING CYCLE. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167334 ↗
• MalfunctionJan 10, 2025Optical Problem; Optical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT IT WAS REPORTED THAT IT WAS SENDING GOOD BLOOD TO THE WASTE BAG. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122077 ↗
• MalfunctionNov 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG INSTRUMENT, IT WAS REPORTED THAT IT WAS OVERFLOWING THE BOWL WHEN PRI MING. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20804173 ↗
• MalfunctionNov 21, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, THE CUSTOMER REPORTED THAT THE 'GOOD' BLOOD WAS BEING FLUSHED STRAIGHT TO THE WASTE BAG. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744742 ↗