Paradigm® REAL-Time Revel™ MMT-723NAP (UDI 00643169507241)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,564 adverse event reports that list this exact device (DI 00643169507241), received between May 24, 2017 and Feb 21, 2023 — classified as 7 deaths, 532 injuries, 1,025 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (293 reports).

14 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,564 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Material Integrity Problem; Material Integrity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO REMOVE THE BATTERY CAP FROM THE PUMP AND THEY HAVE TRIED DIFFERENT COINS. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND THE PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406846 ↗
• MalfunctionSep 8, 2022Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND DIMINISHED BATTERY LIFE. INSULIN PUMP HAD LOUDER REWINDS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15376668 ↗
• MalfunctionAug 11, 2020Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT BUTTON WAS SLOW TO RESPOND. THE CUSTOMER WAS REPORTED THAT INSULIN PUMP HAD REJECTED NEW BATTERIES. 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 10389865 ↗
• MalfunctionAug 11, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTONS WERE NON RESPONSIVE AND REWIND MULTIPLE TIMES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS REJECTED NEW BATTERIES AND DIMINISHED BATTERY LIFE FROM WHEN FIRST RECEIVED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10389736 ↗
• MalfunctionAug 6, 2020Excess Flow or Over-Infusion; Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Excess Flow or Over-Infusion; Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BOTTOM BUTTONS WERE HARDER TO PUSH. CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALARMS AND MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THEY DID NOT WEAR INSULIN PUMP BECAUSE EITHER IT HAVE TOO MUCH OF INSULIN OR GAVE TOO LITTLE INSULIN. INSULIN PUMP ALSO HAD SCRATCHES ON SCREEN. CUSTOMER DECLINED TO TROUBLESHOOTING WITH 24 HOURS HELPLINE. 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 10372233 ↗
• MalfunctionAug 4, 2020Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD TO PRESS SOME BUTTONS HARDER OR MULTIPLE TIMES FOR INSULIN PUMP TO RESPOND AND INSULIN PUMP HAD RUN OUT INSULIN WITHOUT WARNING. 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 10361093 ↗
• MalfunctionAug 4, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Communication or Transmission Problem; Material Integrity Problem; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Communication or Transmission Problem; Material Integrity Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S ACT AND DOWN ARROW BUTTONS WERE HARDER TO PRESS. CUSTOMER REPORTED THAT THE INSULIN PUMP REJECTED NEW BATTERIES AND ALSO SLOWER TO REWIND. INSULIN PUMP MADE LOUDER GRINDING NOISE DURING REWIND PROCESS AND BATTERY CAP WAS STRIPPED. CUSTOMER DECLINED TO TROUBLESHOOTING WITH 24 HOURS HELPLINE. 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 10360554 ↗
• MalfunctionJul 28, 2020Device Alarm System; Battery Problem; Detachment of Device or Device Component; Environmental Compatibility Problem; Device Alarm System; Battery Problem; Detachment of Device or Device Component; Environmental Compatibility Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD LOW BATTERY AND LOW RESERVOIR ALARM 3 TIMES, THE DRIVE SUPPORT CAP WAS LOOSE AND THE INSULIN PUMP WAS EXPOSED TO HIGH MAGNETIC FIELD 3 TIMES. 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 10332676 ↗
• MalfunctionJul 27, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD DIMMER SCREEN MAKING IT HARDER TO READ. 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 10325282 ↗
• MalfunctionJul 27, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTON WAS UNRESPONSIVE. 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 10325263 ↗
• MalfunctionJul 27, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT ALL THE BUTTONS OF INSULIN PUMP WAS NOT WORKING. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND IT ADVANCE. 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 10324796 ↗
• MalfunctionJul 26, 2020Obstruction of Flow; Battery Problem; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD STUCK DURING REWIND PROCESS. CUSTOMER REPORTED THEY GOT STUCK DURING REWIND, BATTERY LIFE WAS DIMINISHED EVERY THREE WEEKS AND UNEXPLAINED NO DELIVERY ALERTS OCCUR ALL THE TIME. 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 10324615 ↗
• MalfunctionJul 26, 2020Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD DRIVE SUPPORT CAP STICKING OUT AND COSMETIC DAMAGES. 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 10324564 ↗
• MalfunctionJul 24, 2020No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP FALL IN THE POOL AND WAS NOT WORKING. THE CUSTOMER STATED THAT THE INSULIN PUMP DISPLAY WENT BLANK. 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 10318794 ↗
• MalfunctionJul 24, 2020Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR. THE MOTOR GRIND SLOWER AND LIGHT AND ALSO BATTERY IF WAS DIMINISHED. THE INSULIN PUMP HAD SCRATCHES AND ALSO HAD NO DELIVERY ALERTS. CONTRAST WAS DIM AND INSULIN PUMP ALSO RECEIVED UNEXPECTED ERROR CODE. 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 10318792 ↗
• MalfunctionJul 23, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK SCREEN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED DISPLAY WAS BLANK CURRENTLY. CUSTOMER REMOVE THE BATTERY AND STATES INSERT BATTERY ALARM DID NOT DISPLAY ON THE INSULIN PUMP SCREEN. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WERE NEITHER MISSING NOR DAMAGED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE SPRING WAS NEITHER DAMAGED NOR CORRODED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10313036 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE STICKING SOMETIMES. CUSTOMER STATED INSULIN PUMP HAD CRACKS NEAR BELT CLIP AND PROTECTIVE COATING PEELED OFF. CUSTOMER STATED INSULIN PUMP HAD SCRATCHES ON SCREEN AND HAD TILT TO READ THE SCREEN. 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 10306976 ↗
• MalfunctionJul 21, 2020Mechanical Problem; Moisture or Humidity Problem; Mechanical Problem; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS LEAKING. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT ABLE TO REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301052 ↗
• MalfunctionJul 21, 2020Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM AND FAILED BATTERY TEST THRICE WITHOUT LOW BATTERY ALERTS AND IT JUST SHUTS OFF. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND WERE ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER REPORTED DISPLACEMENT TEST PASSED AND MANUAL PRIME WERE SUCCESSFUL AND MOTOR ALARM DID NOT RECUR. 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 10300734 ↗
• MalfunctionJul 21, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Premature Discharge of Battery; Device Difficult to Program or Calibrate; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS WERE HARDER TO PRESS AND BATTERY DIED IN MIDDLE OF PRIMING AND HAD TO RESET. CUSTOMER STATED THAT THE BATTERY LIFE LASTING LESS THAN WEEK. 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 10300526 ↗
• InjuryJul 17, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 458 MG/DL. THE CUSTOMER STATED THEIR BLOOD GLUCOSE LEVEL WAS GOING UP AND UP. THE CUSTOMER STATED THAT THE INSULIN PUMP RECEIVED A MOTOR ERROR ALARM AND WHEN THEY TRIED TO REWIND, IT WENT AWAY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10287777 ↗
• MalfunctionJul 16, 2020Computer Software Problem; Mechanical Problem; Computer Software Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A REWIND ANOMALY AND UNEXPLAINED ERROR MESSAGE. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10281658 ↗
• InjuryJul 16, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 458 MG/DL. CUSTOMER STATED INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE ABLE TO REWIND INSULIN PUMP. CUSTOMER STATED DRIVE SUPPORT CAP WAS SLIGHTLY INTENDED. CUSTOMER WAS PERFORMED DISPLACEMENT TEST AND ALARM WAS OCCURRED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10281251 ↗
• MalfunctionJul 14, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS STOPPING DURING REWIND. 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 10269950 ↗
• DeathJul 14, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING THE CUSTOMER¿S HYPOGLYCEMIA AND PASSING FROM THE ATTORNEY OF THE FAMILY. THE INFORMATION RECEIVED ON JULY 7, 2020 STATED THE FOLLOWING - REPORTER ALLEGES: THE CUSTOMER WAS USING A MEDTRONIC MINIMED (PARADIGM PUMP). ON OR ABOUT THE (B)(6) 2019, THE CUSTOMER'S NEXT OF KIN STATED THROUGH AN ATTORNEY THAT THE CUSTOMER HAD HYPOGLYCEMIA WITH SEIZURES, ACUTE METABOLIC ENCEPHALOPATHY, AND DEATH. THE CUSTOMER WAS LAST KNOWN TO BE ALIVE ON (B)(6) 2019 WHEN HIS SON CONTACTED MEDTRONIC ABOUT A PUMP RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Death; Hypoglycemia; Seizures

  MAUDE report 10269800 ↗

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-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-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