Paradigm® REAL-Time Revel™ MMT-723LNAL (UDI 00643169151345)Recalls & reported problems

Summary

The FDA's MAUDE database contains 239 adverse event reports that list this exact device (DI 00643169151345), received between May 30, 2017 and Jul 30, 2020 — classified as 1 death, 78 injuries, 160 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (52 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 239 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2020Mechanical Problem; Power Problem; Insufficient Device Problem Information; Mechanical Problem; Power Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND UNSPECIFIED INSULIN PUMP 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 10343193 ↗
• DeathJul 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) 2015. THE CAUSE OF DEATH WAS BREATHING DIFFICULTIES. THE CALLER STATED THAT THE CUSTOMER HAD OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP HAD BEEN DISCONNECTED MORE THAN 48 HOURS PRIOR TO PASSING, AT THE TIME OF HOSPITALIZATION. THE CALLER STATED THE CUSTOMER HAD HIGH BLOOD GLUCOSE DUE TO ANXIETY, BUT WAS TAKEN OFF THE PUMP WHEN THEY GOT HOSPITALIZED. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death; Hyperglycemia

  MAUDE report 10330561 ↗
• MalfunctionJul 21, 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, BUTTONS WERE MALFUNCTIONING. THE CUSTOMER WAS REPORTED THAT ARROW DOWN BUTTON DID NOT WORK. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR AND REWIND THE INSULIN PUMP. DOWN ARROW WAS HARD TO RESPOND. THE CUSTOMER WAS REPORTED THAT THE ALARM WAS OCCURRED WITH EVERY BATTERY CHANGE. 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 10300378 ↗
• MalfunctionJul 21, 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 AND A COLD RESET WAS PERFORMED ERROR AND KEYPAD ANOMALY. 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. THE DOWN ARROW BUTTON WAS HARD TO RESPOND. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10300319 ↗
• MalfunctionJul 17, 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 STATED DRIVE SUPPORT CAP SLIGHTLY INTENDED. 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 10287592 ↗
• MalfunctionJul 16, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE NOT RESPONDING. CUSTOMER STATED THAT THE TIME WAS NOT 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 10281501 ↗
• MalfunctionJul 15, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. 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 10275716 ↗
• 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 TOOK THE BATTERY OUT AND PUT IT BACK IN AND SO ON BUT THE PUMP KEEPS ALARMING BUTTON ERROR. 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 10269296 ↗
• MalfunctionJul 8, 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. 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 10244343 ↗
• MalfunctionJul 8, 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. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER REPORTED THAT CRACK WHERE THE UP AND DOWN BUTTONS WERE ON TOP OF THE DISPLAY AND SCRATCH ON BOTTOM OF DISPLAY AND CRACK ON B BUTTON AND GOES TO THE RESERVOIR CHAMBER. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10243668 ↗
• MalfunctionJul 7, 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 BUTTONS ERROR ALARM AFTER DELIVERING A BOLUS. CUSTOMER STATED THAT THERE WAS CRACKS ON INSULIN PUMP CASE AND SCRATCH ON DISPLAY. CUSTOMER STATED THAT INSULIN PUMP WAS DAMAGED. 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 10238438 ↗
• InjuryJun 23, 2020Premature Discharge of Battery; Obstruction of Flow; No Apparent Adverse Event; Premature Discharge of Battery; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON JUNE 12, 2020 WITH BLOOD GLUCOSE OF 600 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN DRIP AND LANTUS IN THE HOSPITAL. CUSTOMER REPORTED THAT INSULIN PUMP HAD NO DELIVERY ALARM AND UNEXPECTED RESTART ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10182658 ↗
• MalfunctionJun 16, 2020Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS HAD TO BE PRESSED MORE THAN ONCE. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD REJECTED NEW BATTERIES, RESERVOIR PORT WAS STARTING TO CRACK AND RANDOM AND UNEXPLAINED NO DELIVERY ALARMS AND MOTOR WAS LOUDER THAN PREVIOUS INSULIN PUMPS. 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 10157077 ↗
• MalfunctionMay 22, 2020No Display/Image; Mechanical Problem; No Display/Image; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AND WHILE CUSTOMER WAS CHANGING THE BATTERY INSULIN PUMP WAS NOT REWIND. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WERE NEITHER MISSING NOR DAMAGED. 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 10081454 ↗
• MalfunctionMay 14, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE DRIVE SUPPORT CAP APPEARS WAS NORMAL. 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 10054994 ↗
• MalfunctionMay 4, 2020Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Insufficient Flow or Under Infusion; Patient Device Interaction Problem

  INFORMATION INDICATED BY MEDTRONIC THAT THE INSULIN PUMP WAS CRACKED AROUND THE RESERVOIR COMPARTMENT AND WOULD NOT DELIVER A BOLUS. THE CUSTOMER STATED THEY HAD A HIGH BLOOD GLUCOSE AND ATTEMPTED TO DELIVER A BOLUS, BUT IT WOULD NOT DELIVER INSULIN. TROUBLESHOOTING WAS NOT COMPLETED AS ATTEMPTS TO CONTACT THE CUSTOMER WERE UNSUCCESSFUL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10020022 ↗
• InjuryApr 1, 2020Device Difficult to Program or Calibrate; Battery Problem; Priming Problem; Device Difficult to Program or Calibrate; Battery Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA AS WELL AS HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 45 MG/DL TO 600 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE BATTERY LIFE DIMINISHED LESS THAN A WEEK, RAINBOW EFFECT ON THE SCREEN, SQUIRTS INSULIN WHILE PRIMING AND BUTTON FAILURE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 9909207 ↗
• MalfunctionMar 25, 2020No Display/Image; Device Difficult to Program or Calibrate; Obstruction of Flow; No Display/Image; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARM, INSULIN PUMP WAS NO LONGER TURN ON. 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 9881101 ↗
• MalfunctionMar 25, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE UP ARROW BUTTON WAS STICKING. 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 9879272 ↗
• MalfunctionMar 20, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR AND INSULIN PUMP WAS NOT 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 9858608 ↗
• MalfunctionMar 18, 2020Device Alarm System; Power Problem; Insufficient Device Problem Information; Device Alarm System; Power Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REJECTED NEW BATTERIES, ALARMS WERE NOT LOUD AND 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 9846362 ↗
• MalfunctionFeb 14, 2020Excess Flow or Over-Infusion; Obstruction of Flow; Material Integrity Problem; Excess Flow or Over-Infusion; Obstruction of Flow; Material Integrity Problem

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED GETTING NO DELIVERY ALARMS AND THAT THE LITHIUM BATTERY INSIDE THE PUMP WAS TURNING ORANGE. THE CUSTOMER ALSO REPORTED A DAMAGED BATTERY CAP. 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 9710133 ↗
• MalfunctionFeb 13, 2020Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER STATED THE INSULIN PUMP HAD REJECTED NEW BATTERY. 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 9705104 ↗
• MalfunctionFeb 11, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COUPLE OF MOTOR ERRORS. THE INSULIN PUMP HAD CRACK FROM BATTERY COMPARTMENT TO CORNER OF SCREEN. TOP OF RESERVOIR PORTION WAS WORE. REWIND PROCESS WAS SLOWER AND LOUDER. DOWN ARROW BUTTON WAS HARDER TO PRESS. 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 9691726 ↗
• MalfunctionDec 18, 2019No Display/Image; No Display/Image

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD DISPLAY ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9486329 ↗

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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-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-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-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