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Paradigm® REAL-Time Revel™ MMT-723NAS (UDI 00613994743930)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-723NAS PRDGM INS V2.3 SK EN · Class 3

All models of Paradigm REAL-Time Revel (180)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Medtronic MiniMed Paradigm REAL-Time Revel is an insulin pump. Many of its 453 reports describe incorrect messages on the screen and mechanical faults, and some describe high or low blood sugar or no insulin delivery. The reports list 5 deaths, 110 injuries and 338 malfunctions. There is 1 open recall, started in February 2026, over insulin delivery that can be too high or too low when the pump is raised or lowered relative to the infusion site.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
453
Deaths reported
5
Injuries reported
110
Recalls naming it
1

Summary

The FDA's MAUDE database contains 453 adverse event reports that list this exact device (DI 00613994743930), received between Jun 5, 2017 and Jun 8, 2026 — classified as 5 deaths, 110 injuries, 338 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (116 reports).

1 FDA recall record name this device's identifier, 1 still open.

13 other recalls cover devices cleared under the same FDA submission (P980022); they may or may not involve this specific model.

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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Feb 13, 2026Class IIOpen, Classified

    All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

    Z-1750-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Device Displays Incorrect Message116
  • Mechanical Problem73
  • Device Difficult to Program or Calibrate54
  • Material Protrusion/Extrusion54
  • Failure to Cycle51
  • Patient Device Interaction Problem46
  • Detachment of Device or Device Component40
  • Obstruction of Flow35

Patient problems

  • No Consequences Or Impact To Patient304
  • Hyperglycemia116
  • Hypoglycemia30
  • Elevated Ketones/ Diabetic Ketoacidosis7
  • Death6
  • Vomiting5
  • No Known Impact Or Consequence To Patient4
  • Nausea3

Recent adverse event reports

The 25 most recent of 453 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 8, 2026Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED TO MINIMED THAT THE CUSTOMER REPORTED THERE WAS NO DELIVERY DURING MANUAL PRIME. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-723NAS. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE. MMT-723NAS WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED..

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25423497 ↗
  • MalfunctionMay 4, 2022Mechanical Problem; Mechanical Problem

    THE COMPLAINT WAS PREVIOUSLY REVIEWED IN EASYTRAK AND WAS CONVERTED INTO SMART SOLVE ON MAY 13, 2016. UPON CONVERSION, THE COMPLAINT RECORD WAS PUSHED INTO REASSESSMENT STATUS FOR REVIEW. IT WAS CONFIRMED THERE WAS NO RELEVANT INFORMATION TO CHANGE THE REPORTABILITY DECISION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14282602 ↗
  • MalfunctionOct 15, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT HAD TO GORILLA GLUE MOTOR TO STAY IN INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10682115 ↗
  • MalfunctionSep 24, 2020Mechanical Problem; Mechanical Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER REPORTS THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10579113 ↗
  • MalfunctionAug 7, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER STATED THAT THE ACT BUTTON WAS NOT RESPONDING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10378172 ↗
  • MalfunctionAug 6, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER REPORTED THE TIME CLOCK DOES ADVANCE. CUSTOMER REPORTED THAT THE BUTTON WAS UNRESPONSIVE. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD DAMAGED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10372804 ↗
  • MalfunctionAug 5, 2020Device Alarm System; Obstruction of Flow; Insufficient Device Problem Information; Device Alarm System; Obstruction of Flow; Insufficient Device Problem Information

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD ERROR CODE AND DID NOT GIVING WARNING WHEN INSULIN WAS LOW IN RESERVOIR. CUSTOMER STATED THE INSULIN PUMP HAD NO DELIVERY ERRORS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10366093 ↗
  • InjuryJul 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    THE CUSTOMER'S SPOUSE REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE WHILE HOSPITALIZED FOR SURGERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THE HIGH WAS BECAUSE THEIR PUMP BROKE AND THEY DISCONNECTED FROM IT. THE CALLER DID NOT MENTION HOW THE CUSTOMER WAS TREATED. THE CALLER DID NOT MENTION ANY SYMPTOMS. IT IS UNKNOWN HOW LONG THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP BEFORE THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AND NO FURTHER INFORMATION WAS PROVIDED AS THE CALLER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 10343100 ↗
  • MalfunctionJul 30, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S ACT BUTTON WAS NOT RESPONDING. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS REJECTING GOOD BATTERIES AND LOUDER WHEN REWINDING. INSULIN PUMP'S SCREEN WAS HARD FOR HIM TO SEE THE TIME AND HAD A RAINBOW EFFECT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10342657 ↗
  • MalfunctionJul 21, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER DID NOT HIT ANY BUTTON COMBINATIONS TO GET IT TO FREE UP. INSULIN PUMP HAD UP ARROW BUTTON DID NOT WORK. CUSTOMER HAD ALREADY REMOVED THE BATTERY DUE TO MULTIPLE OTHER ISSUES. THERE WAS ALSO AN ERROR THAT WOULD POP UP WHEN YOU GO TO LOAD THE SYRINGE THAT WOULD PUSH OUT THE END. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10301141 ↗
  • MalfunctionJul 21, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Detachment of Device or Device Component; Mechanical Problem; Device Difficult to Program or Calibrate; Detachment of Device or Device Component

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD UNEXPECTED RESTART ALARM, BUTTON ANOMALY AND MOTOR ERROR ALARM. DRIVE SUPPORT CAP WAS FLUSHED AND IT WAS GLUED. UP BUTTON DID NOT WORK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10300985 ↗
  • MalfunctionJul 21, 2020Premature Discharge of Battery; Mechanical Problem; Priming Problem; Premature Discharge of Battery; Mechanical Problem; Priming Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARM AND REWIND ANOMALY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT INSULIN SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE INSULIN PUMP WAS NOT FUNCTIONING AT THIS TIME. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10300901 ↗
  • MalfunctionJul 21, 2020Premature Discharge of Battery; Detachment of Device or Device Component; Premature Discharge of Battery; Detachment of Device or Device Component

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER GLUED THE DRIVE SUPPORT BACK ON BECAUSE IT KEPT POPPING OUT AND IT WAS IN THE FLUSH POSITION. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR AND REWIND THE INSULIN PUMP. THE CUSTOMER WAS REPORTED THAT THE ALARM WAS OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER EXPERIENCED MULTIPLE ALARMS AFTER BATTERY CHANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10300371 ↗
  • MalfunctionJul 21, 2020Premature Discharge of Battery; Display or Visual Feedback Problem; Detachment of Device or Device Component; Premature Discharge of Battery; Display or Visual Feedback Problem; Detachment of Device or Device Component

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER GLUED THE DRIVE SUPPORT BACK ON BECAUSE IT KEPT POPPING OUT AND IT WAS IN THE FLUSH POSITION. THE CUSTOMER REPORTED THAT INSULIN PUMP SCREEN WAS FULL BLACK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10300353 ↗
  • MalfunctionJul 8, 2020Detachment of Device or Device Component; Priming Problem; Detachment of Device or Device Component; Priming Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SPREAD OUT INSULIN DURING REWIND PROCESS AND MANUAL PRIME PROCESS. CUSTOMER REPORTED THAT THEY PRESSED THE DRIVE SUPPORT CAP WHILE CONNECTED TO THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10243848 ↗
  • InjuryJul 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    THE HOSPITAL AUTHORITY REPORTED VIA PHONE CALL THAT CUSTOMER HAD DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON UNKNOWN DATE. THE CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL. IT WAS STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. TROUBLESHOOTING WAS PERFORMED FOR THE DAMAGE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

    MAUDE report 10231986 ↗
  • MalfunctionJul 3, 2020Mechanical Problem; Mechanical Problem

    INFORMATION RECEIVED BY MEDTRONIC A THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. NO HARM A MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10229417 ↗
  • MalfunctionJun 28, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S MOTOR DID NOT DELIVERED OR PRIME THE INSULIN FOR SOMETIMES. CUSTOMER ALSO STATED THAT THE BUTTONS WERE STICK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10204635 ↗
  • InjuryJun 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2020 FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 300 MG/DL AND THE OTHER BLOOD GLUCOSE VALUE WAS 127 MG/DL. THE CUSTOMER WAS HOSPITALIZED FOR 19 DAYS AND DID NOT WEAR THE PUMP IN THE HOSPITAL STATED THAT SHE WENT IN FOR DIABETES. THE SIGNIFICANT EVENTS LEADING TO HOSPITALIZATION WERE HER KIDNEYS AND LIVER SHUT DOWN AND WENT TO GO ON DIALYSIS. THE OTHER SYMPTOMS WERE NAUSEA, VOMITING, ABDOMINAL PAIN AND DIFFICULTY BREATHING. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE TROUBLESHOOTING WAS DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Abdominal Pain; Dyspnea; Hyperglycemia; Nausea; Renal Failure; Vomiting

    MAUDE report 10177528 ↗
  • MalfunctionJun 19, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND DRIVE SUPPORT CAP WAS FLUSH. CUSTOMER STATED THAT CANNULA OF INFUSION SET WAS BENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10173414 ↗
  • MalfunctionJun 17, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DRIVE SUPPORT CAP WAS LOOSE. CUSTOMER REPORTED THE THEIR INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER DID NOT RECEIVE MOTOR POSITION ENCODER ALARM. CUSTOMER STATED THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO COMPLETE REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10166053 ↗
  • MalfunctionJun 15, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERRORS FREQUENTLY. IT WAS STATED THAT THE INSULIN PUMP HAD FAILED BATTERY TEST, IT WAS REJECTING CHEAPER BRAND NEW BATTERIES, IT SOMETIMES HAS TO REWIND MORE THAN ONCE PER RESERVOIR CHANGE. IT WAS STATED THAT REWIND WAS SLOWER THAN IN THE PAST, THE ESCAPE BUTTON WILL NOT WORK IF HE WAS SWEATING OR THERE WAS ANY MOISTURE AROUND AND HAS CAUSED ISSUES WITH THERAPY, SOMETIMES BUTTONS WILL STICK DOWN WHEN PRESSED. IT WAS STATED THAT THERE WAS TYPICAL WEAR AND TEAR ON THE INSULIN PUMP CASING, SCRATCHES ON THE SCREEN THAT DOES NOT EFFECT READABILITY, RANDOM NO DELIVERY ALARMS BUT BELIEVES IT WAS FROM BAD SETS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10152344 ↗
  • MalfunctionJun 10, 2020Failure to Cycle; Detachment of Device or Device Component; Patient Device Interaction Problem; Priming Problem; Failure to Cycle; Detachment of Device or Device Component; Patient Device Interaction Problem; Priming Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS PROTRUDED. CUSTOMER STATED THAT INSULIN SQUIRTED OUT DURING MANUAL PRIMING. CUSTOMER ALSO REPORTED THAT INSULIN PUMP'S SCREEN WAS CRACKED AND WAS UNREADABLE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10136706 ↗
  • MalfunctionJun 9, 2020Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTON ERROR ALARM AND BUTTONS WERE NOT RESPONDING. CUSTOMER REPORTED THAT TIME WAS NOT ADVANCING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10132602 ↗
  • MalfunctionJun 2, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS APPEARED NORMAL. THE TROUBLESHOOTING WAS PERFORMED FOR THE MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARM HISTORY CONTAINS BOTH AN MOTOR POSITION ENCODER ERROR ALARM AND MORE THAN ONE MOTOR ERROR ALARM WITHIN A 30 DAY PERIOD. THE CUSTOMER STATED THAT THERE SEEMS TO BE A CRACK ON THE RESERVOIR COMPARTMENT. THE CUSTOMER STATED THAT IT WILL ALLOW TO REWIND THE INSULIN PUMP BUT WHEN SHE ATTEMPTS TO BOLUS IT WILL GIVE THE ERROR MESSAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10107689 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980022. One submission often covers many models, so check the product and lot details in each record.

  • Z-1749-2026 · Feb 13, 2026 · Open, Classified
    Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
  • Z-1256-2025 · Jan 31, 2025 · Open, Classified
    Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
  • Z-1594-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
  • Z-1587-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
  • Z-1593-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
  • Z-1589-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
  • Z-1592-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
  • Z-1590-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
  • Z-1588-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
  • Z-1591-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
  • Z-2442-2015 · Jul 22, 2015 · Terminated
    Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with d
  • Z-2179-2014 · Jul 21, 2014 · Terminated
    Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combinatio
  • Z-2544-2014 · Mar 13, 2014 · Terminated
    Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K

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