Paradigm® REAL-Time Revel™ MMT-723LNAP (UDI 00643169151352)Recalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 00643169151352), received between Jun 7, 2017 and Aug 25, 2020 — classified as 1 death, 48 injuries, 137 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (53 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 186 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2020No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE WATER GOT INSIDE THE INSULIN PUMP AND IT STOPPED WORKING. 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 10446698 ↗
• MalfunctionJul 27, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS WERE STICKY AND NEED TO PRESS THEM HARD TO RESPOND. MOTOR MADE GRINDING SOUND. 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 10325285 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REWIND ANOMALY. IT WAS NOT WINDING FULLY. ALSO IT WAS NOT ADMINISTERING BOLUS FULLY AND HAD UNEXPLAINED NO DELIVERY ALARMS. 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 10306709 ↗
• MalfunctionJul 21, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR ALERT AND MONITOR ERROR ON THE INSULIN PUMP. THE DRIVE SUPPORT CAP WAS 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 10301100 ↗
• MalfunctionJul 15, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM AND SHE COULD NOT ABLE TO CLEAR 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 10275008 ↗
• MalfunctionJun 10, 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 BUTTONS OF INSULIN PUMP WERE STICKING AND HARDER TO PRESS. THE CUSTOMER STATED THAT THEY RECEIVED MOTOR ERROR MESSAGE, BATTERY LIFE WAS LESS THAN A WEEK AND CRACK ACROSS TOP OF SCREEN. CUSTOMER STATED THAT INSULIN PUMP WAS UNRESPONSIVE. 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 10136887 ↗
• MalfunctionMay 14, 2020Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP CASING WAS CHIPPED. ALSO FAILED BATTERY TEST ONLY WHEN USING A USED BATTERY AND SCRATCHES ON THE SCREEN. 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 10054710 ↗
• MalfunctionMay 12, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED UNDER DELIVERY VIA PHONE CALL. CUSTOMER BLOOD GLUCOSE READING WAS UNKNOWN. TROUBLESHOOT WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10046026 ↗
• MalfunctionMay 6, 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 INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10028077 ↗
• MalfunctionApr 28, 2020Premature Discharge of Battery; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Insufficient Device Problem Information; Premature Discharge of Battery; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON THE INSULIN PUMP WERE HARDER TO PRESS. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. CUSTOMER STATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. INSULIN PUMP WAS LOUDER DURING 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 10007724 ↗
• MalfunctionApr 27, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCREEN ON THE INSULIN PUMP WAS BLANK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS NOT CALLING BACK AFTER RECEIVING A NEW BATTERY CAP. IT WAS ALSO REPORTED THAT THE INSULIN PUMP HAD A CRACK IN THE RIGHT CORNER OF THE PUMP AND A SMALL CRACK IN THE BOTTOM LEFT CORNER ON THE SCREEN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000145 ↗
• MalfunctionFeb 19, 2020Device Alarm System; Battery Problem; Power Problem; Device Alarm System; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT BEEPING WHEN BATTERY WAS LOW. CUSTOMER STATED THAT THE REWINDING WAS LOUDER AND LONGER. 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 9724870 ↗
• MalfunctionFeb 11, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WERE NOT RESPONDING. CUSTOMER WAS USING INSULIN PUMP BELONGED TO MOTHER AS HER INSULIN PUMP WAS 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 9691604 ↗
• MalfunctionFeb 7, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. 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 9680770 ↗
• MalfunctionJan 28, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT AND ESC BUTTONS WERE NOT RESPONDING. CUSTOMER STATED THAT THE TIME WAS ADVANCING. 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 9640270 ↗
• MalfunctionJan 27, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTON WAS TAKING SEVERAL TIMES TO PRESS. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM, LOWER WHEN REWINDING AND REJECT BATTERY. CUSTOMER REPORTED THAT THE INSULIN PUMP BATTERY CAP WAS CRACKED, FEW HAIRLINE FRACTURES BY THE SCREEN AND SEVERAL SCUFF MARKS AROUND 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 9631437 ↗
• MalfunctionJan 9, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE INSULIN PUMP HAD STACK CHECK ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 235 MG/DL. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9568198 ↗
• MalfunctionJan 7, 2020Premature Discharge of Battery; Premature Discharge of Battery

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE ALARM HAPPENED AFTER REPLACE A BATTERY AND EXPERIENCED MULTIPLE ALARMS AFTER BATTERY CHANGE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9556791 ↗
• MalfunctionDec 24, 2019Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM AND CRACK ON THE RESERVOIR WINDOW AND NEAR THE UPPER RIGHT CORNER OF SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9515748 ↗
• MalfunctionDec 20, 2019Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT THE BUTTONS WERE HARD TO PRESS, HAD BUTTON ERROR. BATTERY CAP WAS BROKEN AND BATTERY COMPARTMENT WAS CHIPPED OUT OF IT, SCREEN WAS CRACKED. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE. CUSTOMER DECLINED TROUBLESHOOTING ON BUTTONS HARD TO PRESS AND THE BUTTON ERROR ALARM. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9502278 ↗
• MalfunctionDec 16, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT UNABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT INSULIN PUMP HAD NOT EXPOSED TO HIGH MAGNETIC FIELD. TROUBLESHOOTING WAS PERFORMED FOR MOTOR ERROR ALARM. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED, TO DISCONTINUE USE OF THE INSULIN PUMP AND REFER TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9472247 ↗
• MalfunctionDec 4, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 117 MG/DL. CUSTOMER STATED THAT 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 WAS ADVANCES. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9408358 ↗
• MalfunctionNov 4, 2019Insufficient Flow or Under Infusion; Obstruction of Flow; Moisture or Humidity Problem; Insufficient Flow or Under Infusion; Obstruction of Flow; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALLEGING POSSIBLE UNDER DELIVERY. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 325 MG/DL AT THE TIME OF INCIDENT AND SEVERAL BLOOD GLUCOSE OVER 300 MG/DL. REASONS WHY CUSTOMER ALLEGES INSULIN PUMP WAS UNDER DELIVERING WAS TO BOLUS SEVERAL TIMES TO GET BLOOD GLUCOSE DOWN SOMETIMES. CUSTOMER WAS TREATED WITH INSULIN PUMP AND BOLUS FOR HIGH BLOOD GLUCOSE. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS FATIGUE AND HEADACHE. CUSTOMER STATED INSULIN PUMP WAS WET AND EXPOSED TO MOISTURE AND INSULIN PUMP HAD BENT CANNULA COUPLE OF TIMES. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARMS. CUSTOMER PERFORMED SELF TEST AND IT WAS PASSED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Fatigue; Headache; Hyperglycemia

  MAUDE report 9276547 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON UNKNOWN DATE WITH BLOOD GLUCOSE OF UNKNOWN CUSTOMER HOSPITALIZED FOR HIGH BLOOD GLUCOSE VALUE DUE TO NOT BEING ON THE PUMP AND THE CARE AT THE REHAB FACILITY. CUSTOMER WAS HOSPITALIZED DUE TO NEUROLOGIC SYMPTOMS AND BROKEN HIP AND THEN THEY HAD A TRANS ISCHEMIC ATTACK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hip Fracture; Hyperglycemia; Transient Ischemic Attack

  MAUDE report 9222214 ↗
• MalfunctionOct 11, 2019Excess Flow or Over-Infusion; Obstruction of Flow; Excess Flow or Over-Infusion; Obstruction of Flow

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP WAS POSSIBLY OVER DELIVERING INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO MENTIONED NO DELIVERY ALARMS AND SLOWER PUMP REWINDS. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9177884 ↗

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-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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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