Paradigm® REAL-Time Revel™ MMT-723NAL (UDI 00643169202375)Recalls & reported problems

Summary

The FDA's MAUDE database contains 268 adverse event reports that list this exact device (DI 00643169202375), received between May 26, 2017 and Jul 20, 2020 — classified as 1 death, 73 injuries, 194 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (70 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 268 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10294262 ↗
• MalfunctionJul 13, 2020Display or Visual Feedback Problem; Failure of Device to Self-Test; Moisture or Humidity Problem; Display or Visual Feedback Problem; Failure of Device to Self-Test; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD PARTIAL DISPLAY AND EXPOSED TO MOISTURE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT SELF TEST DID NOT PASSED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263001 ↗
• MalfunctionMay 15, 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 BUTTONS ON THE INSULIN PUMP WERE STICKING. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. 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 10060432 ↗
• MalfunctionApr 22, 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 THE INSULIN PUMP WOULD NOT RESPOND AFTER CHANGING THE RESERVOIR. 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 9985176 ↗
• MalfunctionApr 9, 2020No Display/Image; Power Problem; No Display/Image; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER ALSO STATED INSULIN PUMP HAD BATTERY OUT LIMIT. CUSTOMER REPORTED THEY WERE UNABLE TO CLEAR THE 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 9942769 ↗
• MalfunctionApr 6, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DEVICE WAS SQUIRTING INSULIN OUT DURING MANUAL PRIME PROCESS. 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 9927569 ↗
• MalfunctionApr 3, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM CUSTOMER STATED THAT THEY WERE UNABLE TO CLEAR THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919507 ↗
• MalfunctionMar 19, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCED SENSOR SYSTEM ERROR ALARM. THEY REPORTED THAT THE RESERVOIR DID NOT ALLOW HIM TO GET INSULIN AND THE INSULIN PUMP KEPT REWINDING. THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 9851956 ↗
• MalfunctionMar 19, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT WORKING AND RECEIVED A BUTTON ERROR ALARM. CUSTOMER CONFIRMED THAT THE TIME ADVANCED. 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 9851859 ↗
• InjuryFeb 28, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 800 MG/DL AND FEEL OKAY TO TROUBLESHOOT. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS TREATED WITH INSULIN AND FLUIDS IN HOSPITAL. IT WAS ALSO REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THERE WAS ALSO SCRATCHES ON LIQUID CRYSTAL DISPLAY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9768230 ↗
• MalfunctionJan 30, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD UNEXPECTED RESTART ALARM, BUTTON NOT RESPONDING AND FROZEN DISPLAY. CUSTOMER WAS ABLE TO UNABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. CUSTOMER STATED THAT TIME WAS ADVANCED. TROUBLESHOOTING PERFORMED FOR KEYPAD ANOMALY. 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 9645948 ↗
• MalfunctionDec 18, 2019Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD CRACK ON THE SCREEN AND ALSO HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9486123 ↗
• MalfunctionDec 10, 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. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444266 ↗
• MalfunctionDec 5, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD BATTERY OUT LIMIT THEY WERE NOT ABLE TO PASS FILL CANNULA STEP AS ACT BUTTONS WERE NOT RESPONDING. IT WAS ALSO REPORTED THAT THE TIME ON INSULIN PUMP 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 DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9414954 ↗
• MalfunctionNov 29, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS STOPPED WORKING AND HAD BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT TIME CLOCK FOR ONE MINUTE DOES NOT ADVANCES. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9391311 ↗
• MalfunctionNov 27, 2019Mechanical Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SHUT OFF FOR NO REASON. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE CASING WAS SCRATCHED UP, GRINDING AND POPPING NOISES AT THE END OF REWIND, RANDOM NO DELIVERY ALARMS, LOST SETTINGS, HAD ISSUE WITH MANUAL BOLUS AND SCREEN WAS SCRATCHED BUT DID NOT AFFECT THE READABILITY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9382169 ↗
• MalfunctionNov 7, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. IT WAS REPORTED THAT THE PUMP WAS NO LONGER. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS FLUSH. THE CUSTOMER MENTIONED THAT ITS SOMEHOW STICKING OUT THEY SAID THAT WHEN THEY TRY TO DELIVER INSULIN IT GAVE MOTOR ERROR. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9290504 ↗
• MalfunctionNov 7, 2019Mechanical Problem; Battery Problem; Material Integrity Problem; Power Problem; Mechanical Problem; Battery Problem; Material Integrity Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE BATTERY CAP GASKET WAS MISSING. CUSTOMER REPORTED THAT THE DISPLAY WAS HARD TO READ IN SUNLIGHT. INSULIN PUMP WAS REJECTING NEW BATTERIES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9289340 ↗
• MalfunctionNov 6, 2019Mechanical Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9283181 ↗
• MalfunctionNov 5, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT DRIVE SUPPORT CAP WAS FLUSHED AND THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE THE INSULIN PUMP AND REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281805 ↗
• MalfunctionOct 31, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF THE INSULIN PUMP WERE NOT WORKING AND WERE PEELING OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED UNEXPLAINED NO DELIVERY ALARMS. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258786 ↗
• MalfunctionOct 30, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9254123 ↗
• MalfunctionOct 29, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT REWIND TAKES LONGER WHEN CHANGING SET AND INSULIN PUMP RECEIVED RANDOM NO DELIVERY ALERTS. CUSTOMER DECLINED TO REPORT TO MEDTRONIC 24 HOUR TECHNICAL SUPPORT DEPARTMENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249320 ↗
• MalfunctionOct 17, 2019Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED RF PIC FAILED SELFTEST FOUR TIMES. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202259 ↗
• MalfunctionOct 9, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD CRACKED AND PIECE WAS MISSING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE DEVICE WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9171760 ↗

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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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