Paradigm® REAL-Time Revel™ MMT-723RNAS (UDI 00643169513143)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,970 adverse event reports that list this exact device (DI 00643169513143), received between May 5, 2017 and Nov 18, 2025 — classified as 18 deaths, 865 injuries, 1,087 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (267 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 1,970 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY. THE EVENT INVOLVED PRODUCT(S) MMT-723RNAS. TROUBLESHOOTING WAS NOT PERFORMED. THE REASON FOR CUSTOMER PASSING WAS CANCER. IT WAS UNKNOWN IF THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER COMPLICATIONS WERE REPORTED. MMT-723RNAS WAS RETURNED FOR ANALYSIS.

  Patient problems: Cancer

  MAUDE report 23578470 ↗
• DeathAug 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2020. CAUSE OF DEATH WAS HEART STROKE. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: NO CONTRIBUTING FACTORS WERE IDENTIFIED AND EXPERIENCED HYPERGLYCEMIA WAS TREATED WITH HOSPITALIZATION. THE PUMP WAS NOT WORN AT THE TIME OF PASSING AND THE PUMP WAS NOT WORKING . IT WAS ALSO REPORTED CUSTOMER PASSED AWAY AT HOME. THE LAST KNOWN PRODUCT(S) FOR THIS CUSTOMER ARE AS FOLLOWS: MMT-332A, UNOMEDICAL AND MMT-723RNAS. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL AND NO PRODUCT RETURN IS REQUIRED FOR MMT-723RNAS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hyperglycemia

  MAUDE report 19979782 ↗
• MalfunctionJul 19, 2021Mechanical Problem; Obstruction of Flow; Power Problem; Mechanical Problem; Obstruction of Flow; Power Problem

  INFORMATION INDICATED BY MEDTRONIC THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM AND NO DELIVERY ALARM. CUSTOMER STATED THAT THE NEW BATTERY OF THE INSULIN PUMP WAS UNRESPONSIVE. CUSTOMER STATED THAT THE INSULIN PUMP TOOK LONGER TO REWIND. CUSTOMER DECLINED TROUBLESHOOTING FOR REWIND ANOMALY AS THE DEVICE WAS WORKING FINE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193651 ↗
• MalfunctionNov 6, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS CORRECT. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NO DROPPED OR BUMPED. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE 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 10797569 ↗
• MalfunctionSep 10, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER STATED DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE ABLE TO REWIND INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. 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 10513378 ↗
• MalfunctionSep 2, 2020Loss of Data; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PUMP ERROR ALARM MULTIPLE TIMES. CUSTOMER WAS UNABLE TO CLEAR THE 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 10481208 ↗
• DeathAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2020 FOR HIGH BLOOD GLUCOSE. THE CAUSE OF DEATH WAS SEPSIS. THE CALLER STATED THAT THE CUSTOMER HAD MANY HIGH BLOOD GLUCOSE INCIDENTS THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF HOSPITALIZATION AND PASSING. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. THE INSULIN PUMP HAD BEEN DISCONNECTED MORE THAN 48 HOURS PRIOR TO PASSING, DUE TO OTHER MEDICAL COMPLICATIONS. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death; Hyperglycemia

  MAUDE report 10460769 ↗
• MalfunctionAug 24, 2020Battery Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD LOW BATTERY ALERT AND BATTERY KEPT DRAINING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10441872 ↗
• MalfunctionAug 13, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN HARD TIME SEEING THE DISPLAY ON THE IT, AS PER CUSTOMER INSULIN PUMP LACKING IT'S BRIGHTNESS. 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 10400406 ↗
• MalfunctionAug 12, 2020Device Alarm System; Moisture or Humidity Problem; Device Alarm System; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS VIBRATING WITHOUT AN ALARM AND ALSO HAD WATER IN IT. TROUBLESHOOTING WAS PERFORMED. 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 10395381 ↗
• MalfunctionAug 12, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OVER REPEATED MOTOR ERRORS. THE CUSTOMER STATED THEY WERE NOT ABLE TO CLEAR THE ALARM AND NOT ABLE TO COMPLETE REWIND PROCESS. 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 10394888 ↗
• MalfunctionAug 12, 2020Obstruction of Flow; Power Problem; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP QUIT 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 10394855 ↗
• MalfunctionAug 12, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10394826 ↗
• MalfunctionAug 11, 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 HAD BUTTON ERROR ALARM. THE CUSTOMER ALSO STATED THAT, THE INSULIN PUMP HAD RANDOM OR UNEXPLAINED 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 10389827 ↗
• MalfunctionAug 7, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE UP ARROW ON THE INSULIN PUMP WAS NOT RESPONDING AND HE USED FINGERNAIL TO PRESS IT. THE TIME ON THE INSULIN PUMP 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 10377690 ↗
• InjuryAug 6, 2020No Display/Image; No Display/Image

  CUSTOMER'S DAUGHTER REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED DUE TO UNKNOWN REASON FOR UNKNOWN DATE. CUSTOMER STATED THAT THE INSULIN PUMP WAS DIED AS A RESULT OF WHICH THEY WERE HOSPITALIZED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10371734 ↗
• InjuryAug 6, 2020Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 450 MG/DL. CUSTOMER STATED INSULIN PUMP WAS NOT WORKING AND ALSO HAD PUMP ERROR ALARM. CUSTOMER STATED THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10371704 ↗
• MalfunctionAug 5, 2020Device Alarm System; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Device Alarm System; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S ACT BUTTON WAS STICKY. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD CONDENSATION INSIDE THE SCREEN AND ALARMS WERE FAINT. CUSTOMER HAD RESTART THE REWIND TO COMPLETE AT TIMES AND BACKLIGHT WAS DIM. 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 10366805 ↗
• MalfunctionAug 5, 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 10366244 ↗
• MalfunctionAug 5, 2020Device Alarm System; Device Alarm System

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT GIVING ANY WARNING AND NOT BEEPING. CUSTOMER STATED THAT THE INSULIN PUMP DID NOT BEEP DURING TONE TEST.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 10366025 ↗
• MalfunctionAug 3, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEIR INSULIN PUMP HAD MOTOR POSITION ENCODER ALARM. CUSTOMER REPORTED THAT THEIR INSULIN PUMP HAD MOTION SENSOR TEST FAILURE ALARM AND MOTOR ERROR. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WERE TO CLEAR THE ALARMS AND 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 10360353 ↗
• InjuryAug 3, 2020Insufficient Flow or Under Infusion; Power Problem; Insufficient Flow or Under Infusion; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED FOR DIABETIC KETOACIDOSIS ON (B)(6) 2019. BLOOD GLUCOSE READING WAS 500 MG/DL. THE CUSTOMER STATED THAT DOCTOR TOOK OFF INSULIN PUMP BECAUSE IT WAS NOT WORKING. THE CUSTOMER WAS TREATED WITH INTRAVENOUS DRIP AT THE HOSPITAL. CUSTOMER HAD SYMPTOMS SUCH AS WEAKNESS AND NO BALANCE. TROUBLESHOOTING FOR THE CUSTOMER¿S HIGH BLOOD GLUCOSE WAS PERFORMED. THE CUSTOMER ALLEGED THAT INSULIN PUMP WAS UNDER DELIVERING INSULIN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

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

  MAUDE report 10355716 ↗
• MalfunctionJul 31, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP DID NOT WORKING DUE TO HIGH BLOOD GLUCOSE. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH SHOT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL. DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10348737 ↗
• InjuryJul 30, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER'S SON REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 561 MG/DL. THEY ALSO REPORTED THAT THE INSULIN PUMP RECEIVED INSULIN FLOW BLOCK ALARM DURING BOLUS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN EXITED DURING FILL TUBING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10343091 ↗
• MalfunctionJul 30, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP HAD AN UNRESPONSIVE KEYBOARD. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THE ACT BUTTON AND THE UP AND DOWN ARROW BUTTONS ARE STICKY AND HARD TO GET TO WORK. 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 10342995 ↗

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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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