ACT PlusRecalls & reported problems across all models

We found 3 models of ACT Plus by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 160 adverse event reports in the FDA's MAUDE database, received between Oct 27, 2020 and Sep 23, 2026 — classified as 2 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (145 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 ACT Plus problems

ACT Plus models

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

• ACT Plus® ACT200

  Timer, clot, automated
  78 reports
• ACT Plus® ACT100

  Timer, clot, automated
  52 reports
• ACT Plus® ACT100

  Timer, clot, automated
  30 reports

Recent ACT Plus adverse event reports

The 15 most recent reports across all models, 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 10, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722170 ↗
• 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 13, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234431 ↗
• 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 ↗
• MalfunctionAug 4, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130989 ↗
• MalfunctionMay 7, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT LIQUID QUALITY CONTROL (QC) HAD TO RUN MULTIPLE TIMES TO GET IT TO PASS. THEY GOT INTERMITTENT CHANNEL FAILS. ADDITIONALLY, THE INSTRUMENT'S FAN WAS MAKING A LOUD NOISE. THE INSTRUMENT WAS USED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25109620 ↗
• 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 ↗
• MalfunctionMar 12, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THERE WERE INTERMITTENT CHANNEL FAILURE ISSUES. ADDITIONALLY, THE LIQUID QUALITY CONTROL(QC) FAILED. 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 24580438 ↗
• 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 ↗
• MalfunctionFeb 5, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT WAS FAILING QUALITY CONTROL CHECKS, AND GIVING HIGHER VALUES THAN NORMAL. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBERS OF CONTROL CARTRIDGES USED IS HR-ACT CARTRIDGE LOT NO. 232029079 AND EXPIRES: 04012026. LIQUID CONTROLS WERE USED. QUALITY CONTROL IS PERFORMED ON THIS UNIT ONCE A WEEK AND BEFORE PATIENT TESTING. THERE WAS NO ERROR CODE ASSOCIATED WITH THIS ISSUE, AND NO CONTROL VALUES OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266272 ↗

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