Paradigm® REAL-Time Revel™ MMT-723NAS (UDI 00643169507258)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,413 adverse event reports that list this exact device (DI 00643169507258), received between May 8, 2017 and Oct 16, 2024 — classified as 15 deaths, 1,023 injuries, 2,375 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (690 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 3,413 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2024Moisture or Humidity Problem; Moisture or Humidity Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER REPORTED MOISTURE DAMAGE TO PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-723NAS. TROUBLESHOOTING WAS PERFORMED AND ISSUE WAS UNRESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN WAS REQUESTED FOR MMT-723NAS AND INSULIN PUMP WAS RETUNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20458957 ↗
• MalfunctionMay 24, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT CUSTOMER EXPERIENCED HYPERGLYCEMIA AND RECEIVED NO DELIVERY ALARM. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 348 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA TREATED WITH INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: CUSTOMER TRIED TO BOLUS. THE EVENT INVOLVED PRODUCT(S) MMT-396 AND MMT-723NAS. THE TROUBLESHOOTING WAS PERFORMED. CUSTOMER DECLINED TO CONTINUE WITH TROUBLESHOOTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-396 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-723NAS.

  Patient problems: Hyperglycemia

  MAUDE report 19390501 ↗
• MalfunctionJul 11, 2023Battery Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC, INDICATED THAT THE PUMP BATTERY CHARGE IS SHORTENED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED, BUT WAS NOT SUCCESSFUL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296266 ↗
• MalfunctionJul 11, 2023Battery Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED A LOW BATTERY ALARM OR SHORT BATTERY LIFE. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL CONTINUE USING THE INSULIN PUMP AND THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296262 ↗
• MalfunctionJun 8, 2023Break; Display or Visual Feedback Problem; Obstruction of Flow; Break; Display or Visual Feedback Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED SCREEN WAS SCRATCHED AND FOUND A RAINBOW EFFECT ON SCREEN AND NO DELIVERY ALARMS. NO FURTHER DETAILS WERE PROVIDED. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE USING THE INSULIN PUMP AND THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086004 ↗
• MalfunctionApr 27, 2023No Display/Image; Power Problem; No Display/Image; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED A BATTERY-FAILED ALARM AND THE PUMP WAS NOT TURNING ON. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATES THE CONTACTS ON THE BATTERY CAP ARE NOT MISSING OR DAMAGED. THE CUSTOMER STATES THE DISPLAY RETURNED AND ADVISED BATTERY CHANGE RESOLVED ISSUE AND WE WILL SHIP A COURTESY BATTERY CAP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE. THE PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16821113 ↗
• MalfunctionAug 9, 2021Obstruction of Flow; Power Problem; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED UNEXPLAINED DELIVERY ALARMS. INSULIN PUMP REJECTED BATTERIES. 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 12293142 ↗
• MalfunctionJul 20, 2021Mechanical Problem; Loss of Data; Mechanical Problem; Loss of Data

  INFORMATION RECEIVED BY MED INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THEY REMOVED THE BATTERY AND THEY STATED SEVERAL OTHER ALARMS CAME UP. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL, INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD AND DECLINED MOTOR POSITION ENCODER ERROR ALERT. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ALSO ABLE TO REWOUND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12196397 ↗
• MalfunctionOct 13, 2020Wireless Communication Problem; Wireless Communication Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND WERE ABLE TO COMPLETE THE 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 10675630 ↗
• MalfunctionSep 25, 2020Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD REJECTED NEW BATTERIES ALARM. CUSTOMER STATED CRACK ON THE INSULIN PUMP AROUND THE 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 10590094 ↗
• MalfunctionSep 17, 2020Obstruction of Flow; Battery Problem; Priming Problem; Obstruction of Flow; Battery Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD TO REWIND MORE THAN ONCE AND IT REJECTED NEW BATTERIES. CUSTOMER STATED THAT INSULIN PUMP RECEIVED 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 10545706 ↗
• MalfunctionSep 10, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEIR INSULIN PUMP HAD MULTIPLE MOTOR ERROR ALARMS. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID NOT RECEIVE MOTOR POSITION ENCODER ALARM. CUSTOMER STATED THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WERE ABLE 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 10513302 ↗
• MalfunctionAug 13, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER WAS TRIED ALL RECOMMENDED TROUBLESHOOTING. 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 10402047 ↗
• MalfunctionAug 13, 2020Mechanical Problem; Obstruction of Flow; Detachment of Device or Device Component; Mechanical Problem; Obstruction of Flow; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD INSTANCES OF NO DELIVERY AND MOTOR ERRORS ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DRIVE SUPPORT CAP WAS FLUSHED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10400974 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS RUNNING FROM 300 MG/DL TO 600 MG/DL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10389335 ↗
• MalfunctionAug 10, 2020Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD FADED BUTTONS. INSULIN PUMP HAD NO DELIVERY ALARM. INSULIN PUMP REJECTED NEW BATTERIES. 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 10389175 ↗
• MalfunctionAug 10, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE HARDER TO PRESS. CUSTOMER STATED THE INSULIN PUMP HAD REJECT NEW BATTERIES, UNEXPLAINED NO DELIVERY ALERTS, COULD NOT GET SUSPEND AND REWIND MORE THAN ONCE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. ¿

  Patient problems: Hypoglycemia

  MAUDE report 10383777 ↗
• MalfunctionAug 10, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER STATED THAT BUTTONS OF INSULIN PUMP WERE HARD TO PRESS AND IT WAS LOCKED AND BECOME NON RESPONSIVE. 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 10383651 ↗
• MalfunctionAug 7, 2020Obstruction of Flow; Priming Problem; Obstruction of Flow; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN WAS SQUIRTING WHILE PRIMING. CUSTOMER STATED THAT THE INSULIN PUMP HAD 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 10378084 ↗
• MalfunctionAug 7, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP FREEZING UP, OR LOCKING UP, OR BASICALLY GETTING STUCK MID-RESERVOIR. IT HAS HAPPENED SEVERAL 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 10377648 ↗
• MalfunctionAug 6, 2020Device 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

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER STATED THAT, SOMETIMES HAD TO PRESS BUTTONS TWICE SPECIALLY ACT BUTTON. THE CUSTOMER ALSO STATED THAT, THERE WERE CRACKS IN CASING, BATTERY CAP WORN, SLOWER DURING REWIND AND THERE WERE SCRATCHES ON THE SCREEN, BUT IT DOES NOT PREVENT HIM FROM SEEING 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 10377266 ↗
• MalfunctionAug 6, 2020No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD FULL BLACK SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10377224 ↗
• MalfunctionAug 6, 2020Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem; Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF THE INSULIN PUMP WERE HARDER TO PUSH, THE BATTERY CAP WAS CHIPPED, AND THE BATTERY LIFE HAD DIMINISHED. 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 10372721 ↗
• MalfunctionAug 6, 2020Display or Visual Feedback Problem; Date/Time-Related Software Problem; Power Problem; Display or Visual Feedback Problem; Date/Time-Related Software Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP CLOCK HAD TO REPROGRAMMED. INSULIN PUMP HAD NO RAINBOW EFFECT ON SCREEN. INSULIN PUMP REJECTED NEW BATTERIES. 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 10371906 ↗
• MalfunctionAug 6, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR AND BUTTONS WON'T REPLAY WHEN BEING PRESSED AND STICKY AND DEEP SCRATCHES ON 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 10371708 ↗

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-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-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-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-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