ACT Plus® ACT200Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00643169178410), received between Oct 27, 2020 and Sep 23, 2026 — classified as 1 injury, 77 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (75 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Electrical /Electronic Property Problem

  Medtronic received information that prior to use of a ACT plus instrument, it was reported that despite repeated routine internal cl eaning, for about 1 month now, the instrument has been giving inconsistent values on the 2 channels. The use of the instrument was unspecified. There was no patient impact associated with this event. Medtronic received additional information that ACT values detected appeared to be unrelated to the patient's clinical coagulation si tuation. In addition, Channel 2 freezes after a few seconds of start-up.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868432 ↗
• MalfunctionSep 1, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541046 ↗
• MalfunctionAug 27, 2026Electrical /Electronic Property Problem

  Medtronic received information that at an unspecified time, this ACT plus instrument had tended to function less effectively. Significant measurement discrepancies were observed, which appear to be incorrect as a result. The use of the instrument was unspecified. There was no adverse patient effect reported with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50478522 ↗
• MalfunctionAug 12, 2026Electrical /Electronic Property Problem

  Medtronic received information that prior to use of an ACT plus instrument, it was reported that it was giving inconsistent readings. The use of the instrument was unspecified. There was no patient impact associated with the event. Medtronic received additional information that the readings were impossible given the clinical picture of the patient and when the c ustomer swapped for another ACT machine the results were drastically different.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221166 ↗
• MalfunctionAug 7, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175548 ↗
• MalfunctionMar 30, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT WAS DISPLAYING INACCURATE VALUES. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714655 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT HAD DIFFERENT READINGS ON BOTH SCREENS. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305515 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT HAD AN INCORRECT DATA READING. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304794 ↗
• MalfunctionFeb 9, 2026Electrical /Electronic Property Problem; Temperature Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT HAD AN ISSUE, AND WAS SHOWING EXCESSIVE DIVERGENT VALUES IN THE TWO INPUT FIELDS. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292158 ↗
• MalfunctionJan 26, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THE TEST RESULTS DEVIATED FROM THOSE OBTAINED ON ANOTHER INSTRUMENT FOR THE SAME SAMPLE. THERE WAS NO ERROR CODE. THERE WERE TEST RESULTS OBTAINED BUT HEPARIN WAS NOT ADMINISTERED BASED ON THE RESULTS. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176792 ↗
• MalfunctionDec 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT DID NOT SHOW RELIABLE RESULTS.THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904421 ↗
• MalfunctionDec 1, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT WAS PROVIDING UNDERESTIMATED ACT VALUES. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679128 ↗
• MalfunctionNov 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT SHOWED INCORRECT VALUES WHEN COMPARED WITH ANOTHER INSTRUMENT. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569564 ↗
• MalfunctionOct 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT HAD AN ISSUE OF INCONSISTENT VALUES. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368945 ↗
• MalfunctionOct 15, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT WAS INCREASINGLY PRODUCING INCORRECT MEASUREMENTS. EITHER ONLY ONE CHAMBER WAS BEING MEASURED, OR THE ACT STOPPED AFTER A FEW SECONDS, OR THE CHAMBERS HAD A VERY HIGH TIME DIFFERENCE. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300669 ↗
• MalfunctionMay 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THERE WERE INCORRECT READINGS. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103216 ↗
• MalfunctionMar 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT HAD AN AVERAGE ACTIVATED CLOTTING TIME MEASUREMENT THAT WAS 100 BELOW WHAT OTHER DEVICES MEASURED. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661652 ↗
• MalfunctionMar 12, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT RECORDED UNRELIABLE VALUES. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21581454 ↗
• MalfunctionFeb 24, 2025Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings; Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT HAD A FAILURE IN MEASUREMENT 1. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444348 ↗
• MalfunctionFeb 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE RESULTS WERE ERRONEOUS BETWEEN SCREEN 1 AND 2. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410811 ↗
• MalfunctionFeb 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THE RESULTS WERE ERRONEOUS BETWEEN SCREEN 1 AND 2. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410715 ↗
• MalfunctionFeb 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE DATA OF THE TEST RESULTS VARIES WIDELY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355331 ↗
• MalfunctionFeb 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT EJECTED THE CUVETTE AND DID NOT GIVE RELIABLE R ESULTS.THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21310725 ↗
• MalfunctionJan 22, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT WHEN TESTED THE PATIENT'S POSTOPERATIVE COAGULATION TIME, IT WAS FOUND THAT THE TEST DATA DEVIATED GREATLY FROM THE ACTUAL VALUE (MORE THAN 80), AND THE ACCURATE COAGULATION TIME COULD NOT BE OBTAINED. THE INSTRUMENT WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206847 ↗
• MalfunctionOct 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED A DEVIATION IN THE TEST RESULTS FROM PRE VIOUS RECORDS OCCURRED. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO ERROR CODE ASSOCIATED WITH THIS ISSUE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20505374 ↗