HMS PLUSRecalls & reported problems across all models

We found 2 models of HMS PLUS by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2022 and Sep 23, 2026 — classified as 1 injury, 109 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (98 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 HMS PLUS problems

HMS PLUS models

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

• HMS PLUS 30514

  ANALYZER, HEPARIN, AUTOMATED
  71 reports
• HMS PLUS 30514

  ANALYZER, HEPARIN, AUTOMATED
  39 reports

Recent HMS 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 HMS plus instrument, it was reported that it had motor stall error and Liquid quality control failures, far right channel issue. The instrument was used. There was no patient involvement, so no adverse effect occurred. Medtronic received additional information that the lot number of control cartridges used was 0233611731. Quality control was performed for this unit once a week and control values obtained, QC was done after service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867687 ↗
• MalfunctionSep 22, 2026Electrical /Electronic Property Problem

  Medtronic received information that prior to use of a HMS plus instrument, it was reported that the system was displaying a dispensing terminated message and failing HPT QC. The instrument was used. There was no patient involvement, so no adverse effect occurred. Medtronic received additional information that HPT was a liquid control that customer was running. When customer was using instrument to run daily liquid controls (during HPT control test), some type of stall occurred, stopping the test from its completion. So, the test Failed. Quality control is performed for this unit weekly. There wasn't an error code associated with this issue observed. Control values were not obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852835 ↗
• MalfunctionJan 16, 2026Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE SYSTEM WAS FAILING MULTIPLE QUALITY CONTROLS IN A ROW BEFORE PASSING. THE INSTRUMENT WAS USED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091537 ↗
• MalfunctionOct 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT FAILS QUALITY CONTROL TEST, AND IS UNABLE TO PRINT QC TEST 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 23369741 ↗
• MalfunctionSep 8, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE 6 CHANNEL WAS NOT READING CORREC TLY. IT PASSES SELF-TEST AND ELECTRONIC QUALITY CONTROL (QC). PERFORMING DIAGNOSTIC TEST THE CODE SENSOR TEST 620 IT DOES NOT DETECT AT ALL ON ALL THE CHANNELS, ALSO PERFORMING THE 761 PRINT DROP TIMES TEST SHOWS THAT THE 6 CHANNEL READINGS ARE AROUND 058, 059, 061, THEN IT JUMPS TO 999, 100, 095, THEN 999 THEN BACK TO 063. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994167 ↗
• MalfunctionSep 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE (DURING TESTING) OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE LEVELS WERE NOT READING CORRECTLY. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEVELS ARE RELATED TO LIQUID CONTROLS. NO ERROR CODES WERE ASSOCIATED WITH THE REPORTED ISSUE. NO CONTROL VALUES WERE OBTAINED AND THE LOT NUMBER FOR USED CARTRIDGES ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937486 ↗
• MalfunctionJul 3, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THIS SYSTEM IS BEGINNING TO CONSISTE NTLY FAIL QUALITY CONTROL TESTS THAT ARE BEING RUN ON IT. OTHER UNITS ARE NOT FAILING THE SAME QC LOTS. THE INSTRUMENT WAS REPLACED. 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 22394448 ↗
• MalfunctionJun 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS HMS PLUS INSTRUMENT WAS FAILING QUALITY CONTROL. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. SERVICE SPOKE TO THE CUSTOMER OVER THE PHONE AND NO ERRORS WERE ALARMING. CUSTOMER WAS ADVISED TO CLEAN THE HEATING BLOCK AND TRY A DIFFERENT LOT NUMBER OF CARTRIDGES AND CONTROLS. THIS IS NOT A MECHANICAL ISSUE. REFERRED CUSTOMER TO BEN SMITH. NO FURTHER ACTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329017 ↗
• MalfunctionJun 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THIS UNIT WAS FAILING ABNORMAL CONTROLS INTERMITTENTLY. THE INSTRUMENT WAS USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE IS BETTER DUE TO RETRAINING STAFF ON QC TECHNIQUE, BUT THE ACCOUNT STILL ENCOUNTERS RANDOM FAILURES WITH THIS INSTRUMENT. THEIR DIFFERENT HMS INSTRUMENTS PASS ALL OTHER QC TESTING. THE CUSTOMER IS WATCHING THE QC RESULTS WEEKLY AND WILL ADVISE THE CLINICAL SPECIALIST IF THE FAILURES INCREASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317921 ↗
• MalfunctionJun 20, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT WAS NOT PASSING QUALITY CON TROL, AND WHEN THEY DO PASS THE MEASUREMENTS ARE OUT OF RANGE AND TOO LOW. 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 22296494 ↗
• MalfunctionJun 18, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO PASS THEIR CONTROLS. THE SITE HAS TRIED MULTIPLE CARTRIDGES AND DIFFERENT LOTS WITH NO SUCCESS. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBERS OF CONTROL CARTRIDGES USED WERE: 0231093202, 0231093194, AND 0231001774. QUALITY CONTROL IS PERFORMED ON THIS UNIT ONCE EVERY 7 DAYS. IT WAS REPORTED THAT ONE HMS PLUS INSTRUMENT HAD MULTIPLE MOTOR STALL ERRORS. THE OTHER HMS ANALYZERS REPEATEDLY FAILED LEVEL 2 QUALITY CONTROL. CONTROL VALUES WERE OBTAINED, BUT THE CUSTOMER WAS UNSURE IF THEY WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282091 ↗
• MalfunctionJun 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE HMS PLUS INSTRUMENT WAS UNABLE TO PASS QUALITY CONTROLS. MULTIPLE CARTRIDGES FROM DIFFERENT LOTS WERE TRIED WITHOUT SUCCESS. A BACKUP DEVICE WAS USED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT LIQUID AND ELECTRONIC CONTROLS WERE USED. NO ERROR CODE ASSOCIATED WITH THIS ISSUE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22231502 ↗
• MalfunctionJun 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE HMS PLUS INSTRUMENT WAS UNABLE TO PASS QUALITY CONTROLS. MULTIPLE CARTRIDGES AND DIFFERENT LOTS WERE TRIED WITHOUT SUCCESS. A BACKUP DEVICE WAS USED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT BOTH LIQUID AND ELECTRONIC (ACTTRAC OR HEPTRAC) CONTROLS WERE USED. THERE WAS NO ERROR CODE ASSOCIATED WITH THIS ISSUE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22220743 ↗
• MalfunctionJun 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE HMS PLUS INSTRUMENTS IT WAS NOTED THAT THE INSTRUMENTS WERE FAILING FLAG HEIGHT AND RECEIVING ABNORMAL QUALITY CONTROL RESULTS. THE SAME RESULTS WERE OBSERVED WHEN USING THREE DIFFERENT CARTRIDGES AND INSTRUMENTS. THE INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182669 ↗
• MalfunctionJun 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE OF THE HMS PLUS INSTRUMENTS IT WAS NOTED THAT THE INSTRUMENTS WERE FAILING FLAG HEIGHT AND RECEIVING ABNORMAL QUALITY CONTROL RESULTS. THE SAME RESULTS WERE OBSERVED WHEN USING THREE DIFFERENT CARTRIDGES AND INSTRUMENTS. THE INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182647 ↗

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