Paradigm® REAL-Time Revel™ MMT-723LNAS (UDI 00643169933170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,995 adverse event reports that list this exact device (DI 00643169933170), received between Dec 14, 2017 and Mar 7, 2023 — classified as 12 deaths, 1,231 injuries, 1,752 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (661 reports).

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

13 other recalls cover devices cleared under the same FDA submission (P150019, 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 2,995 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER FACED HIGH BLOOD PRESSURE AND UNDER INSULIN DELIVERY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER CONFIRMED THAT THE INSULIN PUMP SYSTEM WAS BEEN USED WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 16493255 ↗
• MalfunctionFeb 12, 2021Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING FELL OFF. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE. 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 11320026 ↗
• MalfunctionSep 24, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE TOP OF THE RESERVOIR COMPARTMENT HAD CRACKED AND RESERVOIR WAS ABLE TO LOCK IN PLACE BUT SOMETIME IT WAS LOOSE. 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 10578642 ↗
• MalfunctionAug 27, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT WHEN CHANGING THE RESERVOIR THAT TIME PIECE OF PLASTIC WAS CHIP OFF. 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 10460750 ↗
• MalfunctionAug 24, 2020Battery Problem; Power Problem; Patient Device Interaction Problem; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PIECE WAS MISSING IN BATTERY COMPARTMENT. CUSTOMER ALSO NOTICED FAILED BATTERY AND LOW BATTERY ALERT. CUSTOMER STATED THE RESERVOIR LIP RING DID NOT SHOW SIGNS OF DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10443341 ↗
• MalfunctionAug 13, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. THE CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND UNABLE TO COMPLETE THE 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 10400825 ↗
• MalfunctionAug 12, 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 10399871 ↗
• MalfunctionAug 12, 2020Power Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD FAILED BATTERY TEST 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 10394811 ↗
• MalfunctionAug 12, 2020Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A CIRCLE NEAR THE BATTERY ICON. 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 10394581 ↗
• MalfunctionAug 10, 2020Mechanical Problem; Priming Problem; Mechanical Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AN ISSUE DURING PRIMING PROCESS. THE CUSTOMER SATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STUCK IN REWIND COMPLETE OR BOLUS DELIVERY LOOP. THE CUSTOMER STATED INSULIN PUMP EXIT THE REWIND COMPLETE OR BOLUS DELIVERY LOOP AND COMPLETE THE FILL TUBING PROCESS SUCCESSFULLY. 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 10383794 ↗
• MalfunctionAug 7, 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 OF THE INSULIN PUMP WERE STICKY, HARD TO PRESS, AND UNRESPONSIVE AT TIMES. THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALERTS. 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 10379350 ↗
• MalfunctionAug 7, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK 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 10378443 ↗
• MalfunctionAug 7, 2020Display or Visual Feedback Problem; Mechanical Problem; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED ERROR MASSAGE AND LOUDER WHEN REWINDING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS REJECTED NEW BATTERIES AND CHIPS MISSING FROM AROUND THE AREA WHERE INSULIN PUMP REWIND, FRONT SCREEN LOOK ERODED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10378246 ↗
• MalfunctionAug 7, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THE BATTERY WAS CHANGED, BUT THE ISSUE WAS NOT RESOLVED. IT WAS REPORTED THAT THE DISPLAY DID NOT RETURN. 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 10377847 ↗
• MalfunctionAug 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD LOOSED O RING. 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 10377752 ↗
• MalfunctionAug 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RETAINER RING WAS CAME OFF HOWEVER RESERVOIR WAS ABLE TO 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 10377425 ↗
• MalfunctionAug 6, 2020No Display/Image; Obstruction of Flow; No Display/Image; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THAT INSULIN PUMP WENT BLACK WHEN PUT IN NEW BATTERY SCREEN CAME UP WITH NOTHING ON IT FOR SEVERAL MINUTES. INSULIN PUMP ALSO RECEIVED RANDOM NO DELIVERY ALERTS. 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 10377265 ↗
• MalfunctionAug 6, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE STICKY AND HARDER TO PRESS. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS POWER DOWN WITHOUT NOTIFICATION. INSULIN PUMP RECEIVED UNEXPLAINED NO DELIVERY ALERTS AND ALSO BATTERY LIFE WAS LESS THAN A WEEK. CUSTOMER DECLINED TO TROUBLESHOOTING WITH 24 HOURS TECHNICAL SUPPORT. 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 10372195 ↗
• MalfunctionAug 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE ABLE TO REWIND INSULIN PUMP. CUSTOMER STATED UNEXPECTED RESTART ALARM REOCCURRED AFTER INSERTING NEW BATTERY. 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 10372025 ↗
• MalfunctionAug 6, 2020Obstruction of Flow; Battery Problem; Power Problem; Obstruction of Flow; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALERTS, WAS DYING QUICKLY, AND DID NOT PUSH THE INSULIN. 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 10371764 ↗
• MalfunctionAug 6, 2020Computer Software Problem; Device Difficult to Program or Calibrate; Computer Software Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP UP ARROW BUTTON WAS NOT WORKING. CUSTOMER STATED THEY PUT CARBOHYDRATE AND THAT WAS NOT WORKING. CUSTOMER PERFORMED SELF-TEST AND IT WAS PASSED. 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 10371611 ↗
• MalfunctionAug 5, 2020Battery Problem; Priming Problem; Battery Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN SHOOTS OUT DURING PRIMING. 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 10366480 ↗
• MalfunctionAug 4, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD HARD TO PRESS BUTTONS. THE CUSTOMER STATED INSULIN PUMP HAD BATTERY LIFE OF 7 DAYS AND DIMMED BACK LIGHT. 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 10361463 ↗
• MalfunctionAug 4, 2020No Display/Image; Insufficient Flow or Under Infusion; Power Problem; No Display/Image; Insufficient Flow or Under Infusion; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS UNDER DELIVERING. ALSO IT WAS UNRESPONSIVE TO THE NEW BATTERY AND HAD NO DELIVERY ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10360500 ↗
• InjuryAug 3, 2020Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS UNRESPONSIVE. CUSTOMER CLARIFIED THAT THEY HAD INSULIN DRIP BEFORE FILL TUBING PROCESS. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM WITHOUT ANY LOW BATTERY ALARM IN THE HISTORY. CUSTOMER REPORTED THAT THE BATTERY CAP WAS NORMAL. THIS WAS THE SECOND OCCURRENCE OF THE OFF NO POWER ALARM. THE NEW BATTERY RESOLVED THE ISSUE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10355759 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150019, 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-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-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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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