Paradigm® REAL-Time Revel™ MMT-723NAS (UDI 00643169446472)Recalls & reported problems

Summary

The FDA's MAUDE database contains 706 adverse event reports that list this exact device (DI 00643169446472), received between Jun 2, 2017 and Nov 26, 2020 — classified as 6 deaths, 175 injuries, 525 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (118 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 706 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A INSULIN FLOW BLOCK ALARM. 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 10910344 ↗
• MalfunctionAug 12, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY AND MOTOR ERROR. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWIND THE INSULIN PUMP. THE DRIVE SUPPORT CAP WAS NORMAL-SLIGHTLY INDENTED. THE CUSTOMER STATED INSULIN PUMP ALARM AGAIN MOTOR ERROR AND NO DELIVERY ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10396482 ↗
• MalfunctionAug 11, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERRORS. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED INSULIN PUMP RECEIVE UNEXPECTED RESTART ERROR AGAIN. 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 10390116 ↗
• MalfunctionAug 11, 2020Device Alarm System; Device Difficult to Program or Calibrate; Device Alarm System; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUP HAD BUTTON ISSUES AND BATTERY ALARMS WERE NOT WORKING. 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 10389659 ↗
• MalfunctionAug 7, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER WAS NOT ABLE TO CLEAR ALARM. CUSTOMER STATED THAT ALL KEYS WERE NOT RESPONSIVE. 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 10377953 ↗
• MalfunctionAug 6, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD POSSIBLE UNDER DELIVERY. CUSTOMER STATED THAT INSULIN PUMP GIVING LESS AMOUNT OF INSULIN THAN EXPECTED AMOUNT OF INSULIN. ADVISE CUSTOMER TO ENTER BOLUS AMOUNTS MANUALLY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10377234 ↗
• MalfunctionAug 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT DOWN ARROW KEY WAS NOT WORKING. CUSTOMER STATED THAT CLOCK WAS WORKING. 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 10372234 ↗
• MalfunctionJul 29, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10337500 ↗
• MalfunctionJul 29, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTON DID NOT WORK. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK AND IT WAS ADVANCING. CUSTOMER STATED THAT THE EYE SITE WAS BLURRY. CUSTOMER STATED THAT THE INSULIN PUMP HAD LOW BATTERY ALARM. 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 10337320 ↗
• MalfunctionJul 24, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER STATED THEY WERE NOT ABLE TO COMPLETE REWIND PROCESS. 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 10318568 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER STATED THAT INSULIN PUMP HAD UNEXPLAINED RANDOM NO DELIVERY ALARM. CUSTOMER STATED THAT INSULIN PUMP HAD LOUD GRINDING NOISE WHEN REWINDING. 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 10307053 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. CUSTOMER WAS ABLE TO CLEAR ERROR AND REWIND PROCESS. CUSTOMER STATED THAT DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER ALSO REPORTED NO DELIVERY ALARM. 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 10298645 ↗
• MalfunctionJul 17, 2020No Display/Image; Device Difficult to Program or Calibrate; Obstruction of Flow; No Display/Image; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE NOT RESPONDING. CUSTOMER WAS UNABLE TO DELIVER A BOLUS. CUSTOMER STATED THAT INSULIN PUMP QUIT WORKING AND HAD LITTLE CIRCLE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10288091 ↗
• MalfunctionJul 15, 2020Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM DURING REWIND. CUSTOMER REPORTED THAT THE INSULIN PUMP STOP AND STARTING ALARM, NO DELIVERY ALARM. CUSTOMER STATED RESERVOIR COMPARTMENT WAS CRACKED. 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 10274395 ↗
• MalfunctionJul 14, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. 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 10268926 ↗
• InjuryJul 6, 2020Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING LOW BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 50 MG/DL. CUSTOMER STATED THAT HAD NO DELIVERY ALARM. CUSTOMER STATED THAT WAS UNABLE TO GET PAST THE TIME AND DATE SETUP SCREEN AFTER THE INSULIN PUMP RESTARTED A BATTERY CHANGE. CUSTOMER STATED THAT HAS TREATED WITH FOOD. CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE FOR ABOUT 3 WEEKS. CUSTOMER DECLINED TO TROUBLESHOOT INSULIN PUMP FOR LOW BLOOD GLUCOSE BECAUSE HE ATTRIBUTES IT TO THE SETTINGS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10231609 ↗
• MalfunctionJul 3, 2020Premature Discharge of Battery; No Display/Image; Device Difficult to Program or Calibrate; Loss of Data; Premature Discharge of Battery; No Display/Image; Device Difficult to Program or Calibrate; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS DID NOT WORK. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD BLANK SCREEN THAT CAME IN OUT WENT OUT. THE INSULIN PUMP ALSO RECEIVED EXTERNAL RAM CRC ERROR AND UNEXPECTED RESTART ERROR. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. FILL CANNULA WAS RECORDED IN DAILY HISTORY. 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 10229160 ↗
• MalfunctionJun 30, 2020No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WOULD NOT TURN ON AFTER BEING EXPOSED TO MOISTURE. THE CUSTOMER STATED THE DEVICE SHOWS NO SIGNS OF PHYSICAL DAMAGE HOWEVER THE INSULIN PUMP WAS BLANK AFTER BEING EXPOSED TO OCEAN WATER. 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 10210889 ↗
• MalfunctionJun 24, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM BUT UNABLE TO COMPLETE INSULIN PUMP 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 10187478 ↗
• InjuryJun 18, 2020Device Difficult to Program or Calibrate; No Apparent Adverse Event; Device Difficult to Program or Calibrate; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS ON (B)(6) 2020. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 366 MG/DL. CUSTOMER STATED THAT THEY EXPERIENCED KETONES DUE TO NO INSULIN AND DEHYDRATION. CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN DRIP. CUSTOMER STATED THEY HAD BUTTON ERROR ALARM ON THURSDAY NIGHT BUT WAS NOT ABLE TO GET INSULIN FOR SHOTS SO SHE WENT ALL NIGHT WITHOUT INSULIN. CUSTOMER WAS ADMITTED TO THE HOSPITAL FRIDAY MORNING AND SHE WILL BE RELEASED LATE IN 1 OR 2 DAYS. CUSTOMER STATED INSULIN PUMP WAS NOT ABLE TO CLEAR BUTTON ERROR ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Dehydration; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10167172 ↗
• MalfunctionJun 18, 2020Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT BUTTONS OF INSULIN PUMP WERE STICKY. THE INSULIN PUMP REJECTED NEW BATTERIES AND THERE WAS CRACK AT THE BATTERY COMPARTMENT. 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 10166989 ↗
• MalfunctionJun 18, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND THEY WERE UNABLE TO REWIND THE INSULIN PUMP. THE DRIVE SUPPORT CAP APPEARED NORMAL. 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 10166275 ↗
• MalfunctionJun 17, 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 STUCK BUTTON ALARM. CUSTOMER REPORTED THE TIME CLOCK DOES ADVANCE. CUSTOMER REPORTED THAT THE SCREEN NOT COMPLETELY BLANK. NO ALARMS OCCURRED DURING OR AFTER THE TIME THAT THE BUTTONS WERE NOT RESPONDING. INSULIN PUMP BUTTONS BEGAN TO WORK IN LESS THAN 5 MINUTES WITHOUT BATTERY CHANGE. CUSTOMER WAS UNABLE TO TRY INSULIN PUMP WITH REMOTE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10161311 ↗
• MalfunctionJun 16, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD ACT BUTTON WAS HARDER TO PUSH. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD LOST SETTINGS WHEN CHANGING OUT BATTERIES, REWIND WAS SLOWER, THE PUMP HAD NO DELIVERY ALARM. THE CUSTOMER ALSO STATED THAT THE BATTERY CAP HAD CRACK AROUND IT. 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 10157216 ↗
• MalfunctionJun 16, 2020Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR AND ESCAPE BUTTON WAS NOT WORKING. THE CUSTOMER ALSO STATED THAT THEY CANNOT CLEAR BATTERY OUT LIMIT ALARM. 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 10156732 ↗

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-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• 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-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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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