ACT Plus® ACT100 (UDI 00721902793066)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00721902793066), received between May 19, 2022 and Feb 5, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (26 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 30 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 7, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE SYSTEM WAS FAILING ELECTRONIC QUALITY CONTROL (EQC) AND QUALITY CONTROL (QC). 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 23993411 ↗
• MalfunctionNov 11, 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 WILL NOT PASS QUALITY CONTROL (QC) 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 23520502 ↗
• MalfunctionJul 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ACT PLUS INSTRUMENT DID NOT PASS LIQUID CONTROL. 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 22588296 ↗
• MalfunctionMar 31, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT UNIT IS GIVING INCONSISTENT RESULTS BETWEEN THE 2 CHANNELS. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732844 ↗
• MalfunctionFeb 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING TESTING AND MAINTENANCE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT UNIT WAS FAILING QC AND THE TEMPERATURE IS OUT OF RANGE. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER IS UNSURE OF THE CONTROL CARTRIDGE LOT NUMBER. ACTRAC WAS USED. QUALITY CONTROL IS PERFORMED EVERY MORNING, AFTER EACH REPAIR OR PREVENTIVE MAINTENANCE, AND BEFORE EACH CASE. NO ERROR CODE WAS OBSERVED, JUST HIGH TEMPERATURES. CONTROL VALUES NOT OBTAINED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS FOR AN ELECTRONIC QUALITY CONTROL TESTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456567 ↗
• MalfunctionFeb 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE NUMBERS THAT THE SYSTEM IS DISPLAYING DO NOT SEEM TO BE ACCURATE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447016 ↗
• MalfunctionJan 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE ACT PLUS INSTRUMENT WAS OUT OF TOLERANCE ON THE HIGH SIDE FOR THE LIQUID QUALITY CONTROL (QC), AND THE SITE WAS UNABLE TO COMPLETE QC. THE EVENT OCCURRED PRIOR TO USE, AND A BACKUP DEVICE WAS UTILIZED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER RAN EQC MULTIPLE TIMES WITHOUT ERRORS, VERIFYING OPERATION OF INSTRUMENT IS GOOD. CUSTOMER WAS INFORMED TO RE-RUN THE LIQUID QC WITH A LONGER EQUILIBRATION TIME AND ALL LIQUID QC PASSED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21239389 ↗
• MalfunctionNov 19, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, THE CUSTOMER REPORTED THAT THE ABNORMAL CONTROL WILL NOT PROVIDE CORRECT RESULTS. 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 20721673 ↗
• MalfunctionOct 24, 2023Electrical /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 PASSING THE WET QUALITY CONTROLS. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994142 ↗
• MalfunctionOct 10, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT IT FAILED LIQUID QUALITY CONTROL (QC) BUT NOT ELECTRONIC QUALITY CONTROL (EQC). THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903923 ↗
• MalfunctionSep 25, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT IT WOULD NOT PASS WET QC. THE INSTR UMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806280 ↗
• MalfunctionAug 16, 2023Electrical /Electronic Property Problem; Calibration Problem; Electrical /Electronic Property Problem; Calibration Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE STAFF COULD NOT PERFORM CALIBRAT ION/QUALITY CONTROL(QC). IT WAS ALSO REPORTED THAT THE INSTRUMENT FAILED CONTROL. THE INSTRUMENT WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555105 ↗
• MalfunctionJul 18, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT IT WAS FAILING QUALITY CONTROLS (QC'S). THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ACTRAC WAS USED AND PASSED BUT LIQUID CONTROLS WERE ALSO USED AND FAILED. THERE WERE NO ERROR CODES. THE LIQUID CONTROL VALUES WERE NOT OBTAINED OR USED IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17340936 ↗
• MalfunctionJul 3, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME THIS ACT PLUS INSTRUMENT HAD A MEASUREMENT ISSUE. USE OF THE INSTRUMENT WAS UNSPECIFIED AND THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245798 ↗
• MalfunctionJul 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE THIS ACT PLUS INSTRUMENT'S CHANNEL TWO WAS READING LOW DURING PATIENT TESTING AND THIS WAS CONFIRMED WITH QUALITY CONTROLS. THE CUSTOMER HAS CLEANED THE INSTRUMENT AND ENSURED THE DISPENSING TECHNIQUE IS CORRECT. THE INSTRUMENT WAS REPLACED WITH A BACKUP AND THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245456 ↗
• MalfunctionJul 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE THIS ACT PLUS INSTRUMENT'S CHANNEL TWO WAS READING LOW DURING PATIENT TESTING AND THIS WAS CONFIRMED WITH QUALITY CONTROLS. THE CUSTOMER HAS CLEANED THE INSTRUMENT AND ENSURED THE DISPENSING TECHNIQUE IS CORRECT. THE INSTRUMENT WAS REPLACED WITH A BACKUP AND THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245430 ↗
• MalfunctionJun 30, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THIS ACT PLUS INSTRUMENT WAS FAILING WET QUALITY CONTROLS (FLUID QUALITY CONTROL). INSTRUMENT WAS REPLACED WITH A BACKUP AND THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240019 ↗
• MalfunctionJun 30, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE, THE ACT PLUS INSTRUMENT WAS NOT GETTING PROPER READINGS DURING CONTROLS. USE OF THE INSTRUMENT WAS UNSPECIFIED AND THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238034 ↗
• MalfunctionJun 30, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS ACT PLUS INSTRUMENT ONE OF THE VALUES DID NOT SEEM CORRECT. THE ACT DID NOT REACH THERAPEUTIC LEVEL AND A CLINICAL LAB ACT PLUS WAS BORROWED TO COMPARE AND VALIDATE RESULTS. INSTRUMENT WAS REPLACED WITH A BACK UP TO COMPLETE CASE. PATIENT HAD A STROKE, NO DEATH WAS REPORTED. ADDITIONAL INFORMATION WILL BE REQUESTED TO CONFIRM IF THE ISSUE WITH ACT PLUS INSTRUMENT IS RELATED TO PATIENT IMPACT. PARTNER CONFIRMED THAT THIS WAS AN EP STUDY AND ABLATION CASE.

  Patient problems: Stroke/CVA

  MAUDE report 17237970 ↗
• MalfunctionJun 30, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THIS ACT PLUS INSTRUMENT WAS FAILING WET CONTROLS. THE CUSTOMER STATED THAT THE INSTRUMENT WAS FAILING BOTH NORMAL AND ABNORMAL CONTROLS. THE CUSTOMER DID TROUBLESHOOTING BUT THE ISSUE PERSISTED. THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION: THE CUSTOMER HAS REPORTED THAT THE ISSUE HAS BEEN RESOLVED. THE PROBLEM WAS A LOT NUMBER DISCREPANCY THAT LED TO THE TEST RESULTS BEING OUT OF RANGE. ONCE THE CORRECT LOT NUMBER WAS USED THE READINGS WERE IN RANGE. NO FURTHER ACTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237094 ↗
• MalfunctionJun 30, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME THIS ACT PLUS INSTRUMENT WAS GIVING INCONSISTENT VALUES. USE OF INSTRUMENT IS UNSPECIFIED AND THERE IS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237046 ↗
• MalfunctionJun 20, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THIS ACT PLUS INSTRUMENT WAS NOT PASSING QUALITY CONTROL. THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162646 ↗
• MalfunctionJun 15, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THIS ACT PLUS INSTRUMENT WAS FAILING LIQUID QUALITY CONTROLS (QCS). THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134622 ↗
• MalfunctionJun 15, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THIS ACT PLUS INSTRUMENT INTERMITTENTLY STOPPED ITS TESTING AND IT WAS NOT PASSING LIQUID CONTROLS. USE OF THE INSTRUMENT WAS UNSPECIFIED AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. ADDITIONAL INFORMATION: THE CUSTOMER HAS REQUESTED THAT THE INSTRUMENT BE INSPECTED AND REPAIRED PRIOR TO NEXT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134551 ↗