ACT Plus® ACT100 (UDI 00643169178380)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00643169178380), received between May 26, 2021 and Sep 10, 2026 — classified as 1 injury, 51 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (44 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234431 ↗
• 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 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 ↗
• MalfunctionDec 23, 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 NOT GIVING GOOD RESULTS. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23884070 ↗
• MalfunctionNov 19, 2025Device Alarm System; Electrical /Electronic Property Problem; Device Alarm System; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT WILL NOT PERFORM THE QUALITY CONTROLS DESPITE HAVING THE CORRECT SETTINGS AND BEING REBOOTED. THE ERROR MESSAGE THAT APPEARS IS LIGHT PATH FAILURE CH1 AND CH2 (ALL 3 TESTS). 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 23596157 ↗
• MalfunctionSep 10, 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 DID NOT PASS QUALITY CONTROL AFTER SEVERAL ATTEMPTS. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT O OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013468 ↗
• MalfunctionAug 15, 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 PRODUCING ERRATIC RESULTS. 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 22814055 ↗
• MalfunctionApr 25, 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 UNIT FAILED THE ABNORMAL QC (QUALITY CONTROL). CUSTOMER CLEANED THE QC AND TOOK TEMPERATURE AND FOUND IT TO BE 36.9 CELSIUS. RAN THE TEST AND IT PASSED ON THE 4TH TRY BUT FAILED AGAIN ON THE 5TH TRY. ANOTHER ACT UNIT WAS USED WITH THE SAME QC AND IT PASSED ON THE 1ST TRY. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908829 ↗
• MalfunctionApr 2, 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 CONSOLE IS NOT PASSING THE WET TEST. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753572 ↗
• MalfunctionJan 8, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT WHILE RUNNING A SAMPLE DURING A CASE, THE SYSTEM WAS COUNTING DOWN FROM 100 INSTEAD OF COUNTING UP TO 200 SECONDS. THE CUSTOMER WAS NOT EXPECTING CHANGE IN COUNTING AND SAID THAT NO KNOWN CHANGES TO TESTING PARAMETERS OR CARTRIDGE TYPE WERE MADE. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SERVICE TEAM WILL CLOSE THE CASE DUE TO NO RESPONSE FROM THE CUSTOMER AFTER TROUB LESHOOTING DIRECTIONS WERE GIVEN. NO FURTHER ACTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21100066 ↗
• MalfunctionDec 3, 2024Electrical /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 FAILING THE LIQUID QUALITY CONTROL (QC) TEST. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT SERVICE WORKED WITH CUSTOMER OVER THE PHONE TO PERFORM TROUBLESHOOTING. INFORMED CUSTOMER THAT IF ELECTRONIC QUALITY CONTROL(EQC) PASSES THE LIKELIHOOD THE MACHINE IS WORKING IS HIGH AND THAT IT MAY HAVE BEEN A USER ERROR THAT CREATED THE ISSUE. CUSTOMER PERFORMED AN EQC WHILE ON THE PHONE AND IT PASSED. THE BIOMED ENGINEER STATED HE WOULD WORK WITH THE CATH LAB TO PERFORM LIQUID QCS. ALL LIQUID QCS PASSED. SERVICE IS NOT NEEDED AT THIS TIME. NO FURTHER ACTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831447 ↗
• MalfunctionNov 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT WAS GIVING INACCURATE AND INCONSISTENT READINGS. 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 20609264 ↗
• MalfunctionOct 24, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, THE CUSTOMER REPORTED SEEING A SPREAD ERROR DUE TO ABNORMAL LIQUID IN THE QUALITY CONTROL (QC). THE CUSTOMER STATED THAT THEY CAN GET IT TO PASS IF THEY ARE VERY CAREFUL, HOWEVER THE NORMAL USERS OF THE SYSTEM WHO ARE VERY FAMILIAR WITH IT CANNOT GET IT TO PASS. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520910 ↗
• MalfunctionSep 30, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED MULTIPLE LIQUID QUALITY CONTROL TEST FAILS. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332829 ↗
• MalfunctionAug 21, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE CUSTOMER WAS RUNNING PATIENT SAMP LE, AND THE LEFT CHANNEL KEPT READING AS 25. CUSTOMER REPEATED TEST 5 TIMES AND NO CHANGE, AND ALSO HAD ISSUES RUNNING THE CONTROL TESTS. CUSTOMER CLEANED UP SYSTEM AND WAS ABLE TO RUN CONTROLS WITHOUT ISSUE. CUSTOMER RECALCIFIED THE BLUE TOPS BUT THE LEFT CHANNEL WAS STILL READING AT 25. 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 20014527 ↗
• MalfunctionJul 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE ACT MACHINE PASSED BOTH QUALITY CONTROLS (QC), ELECTRONIC AND WET QC, HOWEVER WHEN COMPARED RESULTS WITH THE 2N ACT MACHINE IN THE DEPARTMENT, THE RESULTS ON THIS MACHINE WERE USUALLY MUCH LOWER. THE OTHER MACHINE HAD RESULTS THAT WERE MORE CREDIBLE FOR THE AMOUNT OF HEPARIN GIVEN. 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 19791236 ↗
• MalfunctionJul 15, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, THE CUSTOMER REPORTED THAT IT FAILED THE QUALITY CONTROL ( QC) TEST 3 TIMES. THE USE OF THE INSTRUMENT WAS ASKED BUT UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740391 ↗
• MalfunctionMay 23, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT , THE CUSTOMER REPORTED THAT THEY WERE EXPERIENCING PREMATURE STOPPAGE OF CHANNEL 2 DURING TEST RUNS, DESCRIBED IN DETAIL BELOW: DURING TESTING, CHANNEL 2 CONSISTENTLY STOPPED EARLIER THAN EXPECTED. TEST 1: CHANNEL 1 FINISHED AT 282 SECONDS AND CHANNEL 2 AT 124 SECONDS, INDICATING A A CHANNEL VARIANCE GREATER THAN 12%. TEST 2: CHANNEL 2 STOPPED AT 25 SECONDS. THE TEST WAS TERMINATED AT 37 SECONDS FOR CHANNEL 1 UPON REALIZING THE PREMATURE STOPPAGE. TEST 3 (APPROXIMATELY 45 MINUTES LATER): THE SAME PATIENT WAS TESTED AGAIN, WITH CHANNEL 2 STOPPING AT 63 SECONDS AND CHANNEL 1 AT 279 SECONDS. AFTER NOTICING THE ISSUE, THE LAB PERSONNEL WERE INSTRUCTED TO THOROUGHLY CLEAN THE SYSTEM BEFORE ITS NEXT USE. THE CUSTOMER CLEANED AND TESTED THE SYSTEM, THEY RAN A SERIES OF ACTTRAC, TEMPERATURE VERIFICATION, TWO ABNORMAL, AND TWO NORMAL CAR TRIDGES, TOTALING FOUR TESTS. ALL ABNORMAL TEST RESULTS CAME BACK ACCEPTABLE. ONE NORMAL TEST INDICATED A CHANNEL VARIANCE GRATER THAN 12%, WITH CHANNEL 1 STOPPING EARLY. DESPITE ADHERING TO THE CORRECT TESTING PROCESS, THE CUSTOMER EXPRESSED CONCERNS OVER A POTENTIAL ISSUE WITH THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382103 ↗
• MalfunctionMay 23, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT WAS STILL HAVING THE S AME ISSUE OF CHANNEL 2 STOPPING EARLY. THE CUSTOMER CONFIRMED THE PROPER PROCESS WAS BEING FOLLOWED FOR ALL TESTS AND WAS CONCERNED THERE WAS AN ISSUE WITH THE UNIT ITSELF. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ON 13-MARCH-24, 6 PATIENT TESTS WERE PERFORMED; 4 OF THESE PRODUCED >12% SPREAD ERROR, WITH CHANNEL 2 STOPPING EARLY. THE 1ST FAILED PATIENT TEST WAS REPEATED ON A DIFFERENT INSTRUMENT WITH NO ERROR. THE 2ND FAILED PATIENT TEST WAS REPEATED ON THE SAME INSTRUMENT WITH NO ERROR - RESULT REPORTED. THE 3RD FAILED PATIENT TEST WAS REPEATED ON THE SAME INSTRUMENT WITH SAME >12% ERROR. THE TEST WAS THEN REPEATED ON DIFFERENT INSTRUMENT WITH NO ERROR. THE LAST PATIENT TEST ON THE AFFECTED INSTRUMENT DID NOT PRODUCE AN ERROR - RESULT WAS REPORTED. THE CATH LAB REPORTED TO POCT THAT THEY WERE GETTING MULTIPLE >12% SPREAD ERRORS. POCT RAN 98 AND 190 ACTTRAC WITH NO ERRORS. POCT PERFORMED TEMPERATURE VERIFICATION - PASSED. POCT P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381700 ↗
• MalfunctionApr 15, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE LIQUID HR-NM AND HR-AB ARE RESULTING WITH "INSUFFICIENT DATA" ERRORS; NO RESULT FOR CHANNEL 2. THE COUNT DOWN (PRE-WARMING) DISPLAYS ON BOTH CHANNELS. BUT ONCE THE LIFT WIRE ENGAGES, CHANNEL 2 DOES NOT DISPLAY ANY NUMBERS (SECONDS). CHANNEL 1 DISPLAYS THE NUMBERS (SECONDS) AS USUAL. AT THIS POINT THE ACTTRAC 98 AND 190 ARE PASSING. THIS IS A CONTINUED ISSUE, AND HAVE BEEN SERVICED TWICE IN THE FIELD. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104084 ↗
• MalfunctionApr 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE ELECTRONIC AND WEEKLY CONTROLS ARE OK BUT WHEN A PATIENT IS PROCESSED THE CUSTOMER SEES A DIFFERENCE THAT DOES NOT MAKE SENSE COMPARED TO THE OTHER MACHINE THEY HAVE. THE CUSTOMER HAD A RESULT THAT SEEMED TO BE WRONG, SO THEY ANALYZED IN BOTH ROOMS AND THE ONE IN THE PHILLIPS ROOM WAS 425 AND IN THE SIEMENS ROOM WAS 248. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER ANALYZED THE SAMPLES ON THE CUSTOMERS TWO UNITS, INCLUDING THE REPORTED UNIT. THE BLOOD SHEEP IS REFERRING TO THE ACT CONTROLS. CARTRIDGE LOT# 227359851, NORMAL CONTROL LOT# 226863754, ABNORMAL CONTROL LOT# 228064786. ELECTRONIC QUALITY CONTROL IS PERFORMED DAILY, AND BLOOD SHEEP IS PERFORMED WEEKLY, AND NO ERROR CODE WAS ASSOCIATED WITH THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061366 ↗
• MalfunctionApr 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE ELECTRONIC AND WEEKLY CONTROLS ARE OK BUT WHEN A PATIENT IS PROCESSED THE CUSTOMER SEES A DIFFERENCE THAT DOES NOT MAKE SENSE COMPARED TO THE OTHER MACHINE THEY HAVE. THE CUSTOMER DID AN ACT ON A PATIENT AND THE RESULTS WERE WRONG, IN THE PHILLIPS ROOM IT WAS 470 AND IN THE SIEMENS ROOM IT WAS 283. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059877 ↗
• MalfunctionApr 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE ELECTRONIC AND WEEKLY CONTROLS ARE OK BUT WHEN A PATIENT IS PROCESSED THE CUSTOMER SEES A DIFFERENCE THAT DOES NOT MAKE SENSE COMPARED TO THE OTHER MACHINE THEY HAVE. THE CUSTOMER HAD A RESULT THAT SEEMED TO BE WRONG, SO THEY ANALYZED IN BOTH ROOMS AND THE ONE IN THE PHILLIPS ROOM WAS 425 AND IN THE SIEMENS ROOM WAS 248. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049359 ↗