HMS PLUS 30514 (UDI 00763000158002)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00763000158002), received between May 9, 2022 and Sep 23, 2026 — classified as 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (35 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 39 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 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 ↗
• 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 ↗
• 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 ↗
• 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 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 6, 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 CONSISTENTLY FAILING QUALITY CONTROL (QC) WITH THE SAME LOT OF CONTROL CARTRIDGES THAT ARE PASSING ON ANOTHER SYSTEM. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE INSTRUMENT FAILED LIQUID QC. THE LOT NUMBER OF THE CARTRIDGE THAT WAS USED WAS 230628144. THE LOT NUMBER OF THE NORMAL CONTROL THAT WAS USED WAS 229543879. THE LOT NUMBER OF THE ABNORMAL CONTROL THAT WAS USED WAS 230945225. LIQUID QCS ARE PERFORMED WEEKLY, AND NO ERROR CODE WAS OBSERVED. NO CONTROL VALUES WERE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157132 ↗
• MalfunctionMay 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT IT INTERMITTENTLY FAILED ABNORMAL CO NTROLS. THE INSTRUMENT WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103440 ↗
• MalfunctionMay 29, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT IT INTERMITTENTLY FAILED ABNORMAL QUALITY CONTROLS. THE INSTRUMENT WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103433 ↗
• MalfunctionMay 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT IN THE SYSTEM EXPERIENCED SEVERAL TEST FAILURES FOR HEPARIN ASSAYS. SPECIFICALLY, THE SYSTEM GAVE NO VALUES, THIS ISSUE OCCURRED 3 TIMES USING MULTIPLE CARTRIDGES. SECOND OCCURRENCE, IT WAS REPORTED THAT WHEN RUNNING A TEST ON A CARTRIDGE, THE ERROR COMES BACK AS HPT TEST GREATER THAN 249 SECONDS. THEINSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. ADDITIONALLY, MEDTRONIC SERVICE CALLED CUSTOMER AND WAS INFORMED THAT CUSTOMER WAS RECEIVING OTHER ABNORMAL RESULTS IN REGARD TO HTC DURING THE TIME THE ERROR POPULATED. AFTER THE HTC RETURNED TO WHAT THEY DETERMINED TO BE A NORMAL LEVEL THEY SAID THE ERROR WENT AWAY. THIS IS THE FIRST TIME CUSTOMER HAVE HAD THIS ISSUE WITH THIS UNIT AND DECIDED TO KEEP AN EYE ON IT AND HOLD OFF SERVICE UNLESS IT RECURS. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IT IS UNDETERMINED IF FAIL IS AGAINST THE HMS PLUS UNIT OR THE MULTIPLE CARTRIDGES USED. THE 2ND OCCURRENCE OCCURRED ON THE SAME DAY WITH THE SAME PATIENT. THE REPORTED ISSUE FAILED 2 TIME BUT PASSED DURING THE 3RD TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980113 ↗
• MalfunctionApr 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS HMS PLUS INSTRUMENT HAD FAILED THE ACT LIQUID QC TEST. 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 21918626 ↗
• MalfunctionMar 19, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS HMS PLUS INSTRUMENT HAD A REPEATED ABNORMAL QUALITY CONTROL (QC) FAILED RESULTS. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBER OF THE CARTRIDGES WAS 0229862883. THE ISSUE WAS WITH FAILED LIQUID QC FOR ACT. ABNORMAL QC WAS RUN MANY TIMES WHICH FAILED REPEATEDLY. LIQUID ACT QC IS DONE ONCE A WEEK BY THE CUSTOMER, ELECTRONIC QC IS DONE DAILY. THERE WAS NO ERROR CODE ASSOCIATED WITH THIS ISSUE OBSERVED. IT WAS REPORTED THAT THE ACT QC RESULTS ARE USED TO VALIDATE THE INSTRUMENT, SO VALUES WERE NOT USED IN A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642089 ↗
• MalfunctionMar 4, 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 CHANNELS ARE NOT WORKING AND THE RESULTS HAD A HIGH DISCREPANCY. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21515460 ↗
• MalfunctionFeb 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT UN IT CANNOT PASS QUALITY CONTROL (QC). 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 21446631 ↗
• MalfunctionFeb 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT ONLY THE ABNORMAL CONTROL CARTRIDGES FAILED THE TEST, BUT OTHER CARTRIDGES WORKS AS INTENDED. PERIODICALLY, BOTH CHANNEL WOULD GIVE READINGS, BUT SOMETIMES ONLY ONE CHANNEL WOULD GIVE A READING, THE VALUES RECEIVED WERE LOWER THAN EXPECTED. 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 21446424 ↗
• MalfunctionFeb 19, 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 LIQUID QUALITY CONTROL WOULD NOT PASS AND IT WAS NOT DISPENSING THE SAME AMOUNT IN EACH CHANNEL (5 AND 6). THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414344 ↗
• MalfunctionFeb 10, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, AN ERROR MESSAGE "HPT TEST GREATER THAN 249 SECONDS" WAS ENCOUNTERED WHEN RUNNING A TEST ON THE HMS PLUS INSTRUMENT. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SERVICE TEAM SPOKE TO THE CUSTOMER VIA PHONE AND THEY INFORMED THAT AFTER THE HTC TEST RETURNED TO WHAT THEY DETERMINED TO BE A NORMAL LEVEL, THEY SAID THE ERROR WENT AWAY. THIS WAS THE FIRST TIME THEY HAD THIS ISSUE WITH THIS INSTRUMENT AND THEY DECIDED TO DECLINE SERVICE AT THIS TIME. NO FURTHER ACTION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344457 ↗
• MalfunctionJan 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT WAS NOT PASSING ABNORMAL CONTROLS. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228974 ↗
• MalfunctionDec 2, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, THE CUSTOMER REPORTED THAT THEY WENT TO RUN THE QUALITY CONTROL TESTS ON THE INSTRUMENT AND WERE UNABLE TO PASS. THE CUSTOMER STATED THAT THEY TRIED MULTIPLE TIMES WITH DIFFERENT LOT NUMBERS AND CARTRIDGES WITH NO CHANGE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817344 ↗
• MalfunctionNov 27, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE QUALITY CONTROLS WERE FAILING. 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 IS 0229403400. THE ELECTRONIC QC PASSED BUT THE LIQUID CONTROLS FAILED ABNORMAL ACT (QC LOT# 0229693137). THIS INSTRUMENT IS BRAND NEW AND WAS UNDERGOING CORRELATION STUDIES. LIQUID QC WILL BE DONE WITH EACH SHIPMENT OF CARTRIDGES, WHILE ELECTRONIC QC IS DONE ON EACH PATIENT AND/OR EVERY 8 HOURS. NO ERROR CODES WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798506 ↗
• MalfunctionOct 11, 2024Electrical /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 PASSED ALL LIQUID CONTROLS, EXCEPT THE ACT ABNORMAL QC. THE INSTRUMENT WAS USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426877 ↗
• MalfunctionSep 19, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS HMS PLUS INSTRUMENT DOES NOT GIVE GOOD RESULTS, AS IT DOES NOT FILL THE CARTRIDGE TO THE RIGHT LEVEL. 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 20255287 ↗
• MalfunctionJun 19, 2024Electrical /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 FAILED ELECTRONIC AND LIQUID QUALITY CONTROL CHECKS. THE INSTRUMENT WAS USED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565893 ↗
• MalfunctionMay 7, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THERE WERE CONTROL ISSUES.THE CONTROLS WERE FAILING. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT LIQUID NORMAL AND ABNORMAL ACT CONTROLS WERE RUN AND WERE FAILING. QUALITY CONTROLS ARE PERFORMED WEEKLY. THERE WAS NO ERROR CODE ASSOCIATED WITH THIS PROBLEM. CONTROL VALUES WERE NOT USED. THE DEVICE WAS SET ASIDE UNTIL SERVICE COULD BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257889 ↗