Paradigm® REAL-Time Revel™ MMT-723LNAS (UDI 00643169513914)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,570 adverse event reports that list this exact device (DI 00643169513914), received between May 4, 2017 and Jul 10, 2023 — classified as 23 deaths, 983 injuries, 1,564 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (392 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 2,570 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BATTERY CAP IS DAMAGED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND A REPLACEMENT CAP WILL BE ISSUED. CUSTOMER WILL DISCONTINUE TO USE THE DEVICE AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286175 ↗
• MalfunctionJul 10, 2023Mechanical Problem; Battery Problem; Detachment of Device or Device Component; Mechanical Problem; Battery Problem; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 287 MG/DL AT THE TIME OF THE EVENT. THE CUSTOMER RECEIVED A MOTOR ERROR ALARM AND REPORTED BATTERIES WERE NOT LASTING MORE THAN 2-3 DAYS. TROUBLESHOOTING WAS PARTIALLY PERFORMED AND FOUND THAT THE PUMP DID NOT RECEIVE AN E70-MOTOR POSITION ENCODER ERROR ALARM. ALSO FOUND THAT THE DRIVE SUPPORT CAP WAS SLIGHTLY INDENTED. THE CUSTOMER COMPLETED THE PUMP REWIND AND WAS NOT EXPOSED TO A HIGH MAGNETIC ENVIRONMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 17285081 ↗
• MalfunctionAug 26, 2022Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP ALARMED MOTOR ERROR AND NO DELIVERY ALARM. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303365 ↗
• MalfunctionMay 7, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED REPROGRAM ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 14313849 ↗
• MalfunctionOct 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS DID NOT RESPOND AND DID NOT SCROLL. 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 10639728 ↗
• MalfunctionAug 12, 2020Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD UP AND DOWN ARROWS WERE NOT RESPONDING PROPERLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE TIME WAS ADVANCED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394716 ↗
• InjuryAug 10, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. CUSTOMER REPORTED THAT THE LINE CAN GET CAUGHT IF IT SPRINGS OUT OVERNIGHT WHILE ASLEEP YOU DON'T GET ANY INSULIN WHERE THE ACTUAL CLIP WAS, THERE'S A GAP IN BETWEEN THE HINGE THE LINE WILL GET JAMMED IN THERE AND CUT IT OFF ON. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10388120 ↗
• MalfunctionAug 7, 2020Device Alarm System; Obstruction of Flow; Battery Problem; Power Problem; Device Alarm System; Obstruction of Flow; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S AUDIBLE ALARM WAS NO LONGER WORKING. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. INSULIN PUMP REJECTED BRAND NEW BATTERY AND BATTERY LIFE WAS DIMINISHED. 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 10378255 ↗
• MalfunctionAug 6, 2020Device Alarm System; Device Markings/Labelling Problem; Device Alarm System; Device Markings/Labelling Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP EMITTING A CONSTANT TONE AND NOT BOOT UP. CUSTOMER STATED INSULIN PUMP HAD HIGH PITCHED SQUEAL. 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 10372299 ↗
• MalfunctionAug 5, 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 PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE DEVICE WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM AND 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 10366848 ↗
• MalfunctionAug 4, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE HARDER TO PRESS. CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALARMS AND AND REJECTED NEW BATTERIES. CUSTOMER STATED THAT THERE WAS SCRATCHES ON SCREEN AND SCREEN WAS VERY DIM. INSULIN PUMP WAS LOUDER DURING REWIND PROCESS. 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 10362555 ↗
• InjuryAug 4, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; 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 500 MG/DL. CUSTOMER STATED THAT THEY HAD A MOTOR ERROR ALARM CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10361322 ↗
• MalfunctionAug 4, 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. THE DRIVE SUPPORT CAP WAS FLUSHED. 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 10360470 ↗
• MalfunctionJul 30, 2020Device Alarm System; No Display/Image; Moisture or Humidity Problem; Device Alarm System; No Display/Image; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THAT THERE WAS HIGH PITCHED TONE. CUSTOMER STATED THAT THERE WAS NEITHER VIBRATING NOR BEEPING CURRENTLY. CUSTOMER STATED THAT INSULIN PUMP WAS 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 10342608 ↗
• MalfunctionJul 29, 2020Premature Discharge of Battery; Electrical /Electronic Property Problem; Use of Device Problem; Premature Discharge of Battery; Electrical /Electronic Property Problem; Use of Device Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE INSULIN PUMP 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 10336664 ↗
• MalfunctionJul 28, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR AND BATTERY COMPARTMENT WERE CRACKED. THE CUSTOMER STATED THAT THE RESERVOIR DID LOCK IN PLACE. 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 10330734 ↗
• MalfunctionJul 24, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD ACT BUTTON HARD TO PRESSED. 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 10319380 ↗
• MalfunctionJul 21, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED ERROR. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM AND ALSO WAS ABLE TO REWIND THE PUMP. CUSTOMER ALSO REPORTED THAT ALARMED RECURRED AFTER INSERTING A NEW BATTERY. TROUBLESHOOTING WAS PERFORMED. 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 10301142 ↗
• MalfunctionJul 21, 2020Premature Discharge of Battery; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED UNEXPECTED ALARM. CUSTOMER REPORTED THAT THE INSULIN PUMP REJECTED NEW BATTERY. THERE WAS CRACK NEAR RESERVOIR COMPARTMENT. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS SLOWER 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 10300887 ↗
• MalfunctionJul 20, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER ALLEGED THE INSULIN PUMP FOR OVER DELIVERY. THE CUSTOMER ALSO REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL AND TREATED WITH FOOD. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER ALLEGED THE INSULIN PUMP FOR OVER DELIVERY BECAUSE THE CUSTOMER MENTIONED THAT NORMALLY HER BLOOD GLUCOSE LEVELS WERE OKAY BUT ONCE SHE RESUMED INSULIN PUMP THERAPY AFTER BEING OFF FOR SEVERAL MONTHS, SHE STARTED HAVING LOW BLOOD GLUCOSE LEVELS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP AND RESERVOIR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10294040 ↗
• MalfunctionJul 17, 2020No Display/Image; Display or Visual Feedback Problem; Visual Prompts will not Clear; No Display/Image; Display or Visual Feedback Problem; Visual Prompts will not Clear

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK AND FROZEN DISPLAY. CUSTOMER STATED THE SCREEN WAS VERY DIM AND BLOOD GLUCOSE WAS RUNNING HIGH. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10288050 ↗
• MalfunctionJul 16, 2020Mechanical Problem; Date/Time-Related Software Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Date/Time-Related Software Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP LOST MINUTES AND WAS NOT ALWAYS ON TIME. ALSO THERE WAS CRACK NEAR UPPER RIGHT CORNER OF SCREEN AND RESERVOIR COMPARTMENT, LOST BOLUS SETTINGS AND WAS LOUDER WHEN REWINDING. 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 10281623 ↗
• MalfunctionJul 16, 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 DRIVE SUPPORT CAP WAS FLUSHED. THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY 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 10281481 ↗
• MalfunctionJul 15, 2020Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Power Problem; Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WAS STARING TO GET SCRATCHES TO MAKE IT A LITTLE HARD TO SEE, MOTOR ERROR, REJECTS NEW BATTERIES. 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 10275585 ↗
• MalfunctionJul 15, 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 THERE WERE MINOR SCRATCHES AND CRACKS BUT DOES NOT IMPEDE THERAPY AND THE UP AND DOWN BUTTONS OCCASIONAL STUCK. 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 10274461 ↗

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