Paradigm® REAL-Time Revel™ MMT-723NAS (UDI 00643169202399)Recalls & reported problems

Summary

The FDA's MAUDE database contains 796 adverse event reports that list this exact device (DI 00643169202399), received between May 18, 2017 and Sep 4, 2020 — classified as 6 deaths, 180 injuries, 610 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (192 reports).

1 FDA recall record name this device's identifier, 1 still open.

13 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.

Recalls naming this device

1. Feb 13, 2026Class IIOpen, Classified

   All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

   Z-1750-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 796 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2020Mechanical Problem; Use of Device Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Use of Device Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REWINDS AND REPRIMES ISSUES. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALERT AND ALSO REJECTED NEW BATTERY AND SURFACE SCRATCHES ON RESERVOIR WINDOW AND 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 10492616 ↗
• MalfunctionAug 12, 2020Display or Visual Feedback Problem; Battery Problem; Display or Visual Feedback Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT SCREEN OF INSULIN PUMP WAS GETTING DARK AND IT HARD TO READ. 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 10395074 ↗
• MalfunctionJul 31, 2020Premature Discharge of Battery; Mechanical Problem; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD ACT AND ESC KEYS WERE NOT RESPONDING. THE CUSTOMER REPORTED THEY HAD INSULIN PUMP ERROR ALARM AND WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND AND HAD BEEN EXPOSED TO MOISTURE. 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 10348723 ↗
• MalfunctionJul 23, 2020Display or Visual Feedback Problem; Material Integrity Problem; Patient Device Interaction Problem; Priming Problem; Display or Visual Feedback Problem; Material Integrity Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SHOOT OUT INSULIN DURING PRIMING. CUSTOMER STATED THAT THERE WAS A CRACK IN THE BATTERY CAP. CUSTOMER MENTIONED THAT THERE WAS BACKLIGHT DIM ON 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 10313842 ↗
• MalfunctionJul 20, 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 A THAT THE INSULIN PUMP HAD BLANK DISPLAY, BUT WHEN HE PUTTING THE BATTERY IN, IT WAS RECEIVED A BUTTON ERROR. NO HARM A INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295425 ↗
• MalfunctionJul 20, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR AND INSULIN PUMP ERROR. THE CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM DUE TO THE BUTTON ERROR. THE 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 10294613 ↗
• MalfunctionJul 15, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT THE BATTERY COMPARTMENT AND BATTERY WINDOW WAS CRACKED. 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 10275402 ↗
• MalfunctionJul 14, 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. THE CUSTOMER STATED THAT NO BUTTONS WERE 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 10270043 ↗
• MalfunctionJul 14, 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. CUSTOMER STATED THAT THEY WERE UNKNOWN THAT THEY PRESS A BUTTON DOWN FOR 3 MINUTES OR LONGER. 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 10269421 ↗
• MalfunctionJul 13, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED UNEXPECTED POWER LOSS ALARM AND KEYPAD ANOMALY. CUSTOMER WAS ABLE TO CLEAR THE ALARM. IT WAS REPORTED THAT THE BUTTONS OF THE INSULIN PUMP WERE NOT RESPONDING. 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 10263861 ↗
• MalfunctionJul 13, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARMS. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS CRACKED NEAR THE RESERVOIR ENTRY. INSULIN PUMP SETTINGS WERE CLEARED WHEN CHANGING BATTERIES AND REPLACING INFUSION SET. 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 10262991 ↗
• MalfunctionJul 10, 2020Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM, WAS NON RESPONSIVE TO A NEW BATTERY, WAS GETTING RANDOM NO DELIVERY ALARMS, HAD DIMINISHED BATTERY LIFE, AND THE BACK LIGHT WAS NOT WORKING CONSISTENTLY. THE CUSTOMER STATED THE PUMP ALSO HAD PHYSICAL DAMAGE TO THE SCREEN AND BATTERY CAP AREA. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. 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 10257439 ↗
• MalfunctionJul 3, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE 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 10229416 ↗
• MalfunctionJun 26, 2020Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. 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 10199110 ↗
• MalfunctionJun 19, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THAT 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 10174155 ↗
• MalfunctionJun 18, 2020Power Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS STOPPED WORKING. 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 10166135 ↗
• MalfunctionJun 17, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS PROTRUDED. 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 10161985 ↗
• MalfunctionJun 16, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM, ALSO BUTTONS WERE NOT RESPONDING. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR AND REWIND THE INSULIN PUMP. THE CUSTOMER WAS REPORTED THAT THE ALARM WAS OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. 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 10160734 ↗
• MalfunctionJun 10, 2020Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM AND REPORTED THAT HE WAS NOT GETTING ANY RESPONSE FROM ANY BUTTON. CUSTOMER REPORTED THAT THERE WAS FLUID UNDER THE LIQUID CRYSTAL DISPLAY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138794 ↗
• MalfunctionJun 8, 2020Premature Discharge of Battery; Mechanical Problem; Obstruction of Flow; Material Integrity Problem; Power Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Mechanical Problem; Obstruction of Flow; Material Integrity Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM, MOTOR ERROR ALARM AND IT WAS SHUTTING DOWN. CUSTOMER REPORTED THAT THE BATTERY CAP WAS STRIPPED OUT AND INSULIN PUMP HAD NO DELIVERY ALARMS. 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 10127423 ↗
• InjuryJun 6, 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 THEY WERE HOSPITALIZED DUE TO HYPERGLYCEMIA AND PASSED OUT ON (B)(6) 2020. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER EXPERIENCED FOOD POISON OR INFECTION. THE CUSTOMER WAS TREATED WITH STRONG ANTIBIOTICS OR INTRAVENOUS FLUID. THE INSULIN PUMP BUTTONS WERE NOT RESPONDING AFTER REPLACING BATTERY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10126313 ↗
• MalfunctionMay 28, 2020Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10095105 ↗
• InjuryMay 11, 2020Visual Prompts will not Clear; No Apparent Adverse Event; Visual Prompts will not Clear; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 406 MG/DL. CUSTOMER STATED THAT INSULIN PUMP HAD A FROZEN DISPLAY BUT NOT COMPLETELY BLANK. CUSTOMER STATED THAT INSULIN PUMP WAS UNRESPONSIVE DURING THE RESTART. CUSTOMER STATED THAT WAS UNABLE TO TROUBLESHOOT FOR THE HIGH BLOOD GLUCOSE BECAUSE THE INSULIN PUMP WAS NOT ABLE TO START. CUSTOMER STATED THAT CUSTOMER WAS GOING TO TREAT THE BLOOD GLUCOSE WITH A MANUAL INJECTION, BUT HAD NOT YET AT THE TIME OF THE CALL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10041928 ↗
• MalfunctionApr 30, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED A MOTOR ERROR. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE 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 10012667 ↗
• MalfunctionApr 24, 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. CUSTOMER WAS REPORTED 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 9998094 ↗

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