Paradigm® REAL-Time Revel™ MMT-723NAH (UDI 00643169507227)Recalls & reported problems

Summary

The FDA's MAUDE database contains 935 adverse event reports that list this exact device (DI 00643169507227), received between Jun 1, 2017 and Feb 20, 2025 — classified as 3 deaths, 313 injuries, 619 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (174 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 935 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Material Integrity Problem; Material Integrity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER REPORTED PHYSICAL DAMAGE TO THE INSULIN PUMP AND CAN NO LONGER BE USED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-723NAH, MMT-381, MMT-381, MMT-381, MMT-381, MMT-381 AND MMT-381 . TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND MMT-723NAH WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419102 ↗
• MalfunctionJul 20, 2021Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE ABLE TO REWIND INSULIN PUMP. CUSTOMER STATED DRIVE SUPPORT CAP APPEARS NORMAL. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12196331 ↗
• MalfunctionOct 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK ON PUMP CASING AND BOTTOM OF 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 10760332 ↗
• MalfunctionAug 13, 2020Mechanical Problem; Environmental Compatibility Problem; Mechanical Problem; Environmental Compatibility Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. INSULIN PUMP WAS EXPOSED TO MAGNETIC RADIATION IMAGE. 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 10401917 ↗
• MalfunctionAug 11, 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 MISSING BUTTON ERRORS AND REWIND MORE THAN ONCE PER RESERVOIR CHANGE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND WAS RESOLVED BY CHANGING COMPLETE SET. 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 10389348 ↗
• MalfunctionAug 10, 2020Mechanical Problem; Environmental Compatibility Problem; Mechanical Problem; Environmental Compatibility Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER ALSO REPORTED INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR. CUSTOMER STATED INSULIN PUMP EXPOSED TO HIGH MAGNETIC ENVIRONMENT. 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 10384324 ↗
• MalfunctionAug 10, 2020Device Alarm System; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Device Alarm System; Mechanical Problem; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S ALARM WAS NOT ALERTING ANYMORE. CUSTOMER STATED THE INSULIN PUMP HAD CRACK IN RESERVOIR WINDOW, REWIND WAS SLOWER AND GOING THROUGH BATTERIES QUICKER. 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 10383713 ↗
• MalfunctionAug 7, 2020Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE STICKING. INSULIN PUMP BATTERY LID MESSED UP. 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 10377816 ↗
• InjuryAug 7, 2020No Display/Image; No Display/Image

  CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS IN EMERGENCY ROOM DUE TO PUMP WAS NOT WORKING BUT IT WAS WORKING WITH SOMEONE FOR A NEW PUMP. THE TROUBLESHOOTING WAS DECLINED BY CUSTOMER. NO INFORMATION ABOUT THE TREATMENT WAS GIVEN. THE DEVICE WILL NOT TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10377445 ↗
• MalfunctionAug 5, 2020Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP WAS SLOWER TO REWIND. CUSTOMER STATED THAT THE INSULIN PUMP REJECTED 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 10366051 ↗
• MalfunctionAug 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP GAVE E ERROR CODE AND REQUIRED 2 BATTERIES A MONTH. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10360909 ↗
• MalfunctionJul 29, 2020Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT ACT BUTTON WAS HARD TO PUSH. THE CUSTOMER STATED THAT INSULIN PUMP HAD REJECTED NEW BATTERIES, PRIMING ACTION WILL NOT OCCUR DUE TO ACT BUTTON. 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 10336731 ↗
• MalfunctionJul 28, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARD TO PRESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10330816 ↗
• MalfunctionJul 23, 2020Device Alarm System; Device Alarm System

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER HEARD CLICKING WHILE GIVING BOLUS. 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 10313027 ↗
• MalfunctionJul 21, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS DID NOT RESPOND RIGHT AWAY WHEN PRESSED. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALERTS, BATTERIES DID NOT LAST SEVEN DAYS AND INSULIN PUMP HAD REJECTED BATTERIES. THE BATTERY COMPARTMENT WAS DISCOLORED OR HAD CORROSION BUILD UP. 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 10301177 ↗
• MalfunctionJul 18, 2020No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT ACT BUTTON WAS UNRESPONSIVE. THE INSULIN PUMP TOOK LONG TIME TO START UP AFTER A BATTERY CHANGE AND HAD A BLANK DISPLAY AFTER A BATTERY CHANGE. THE CLOCK RUNS SLOW AND HAD TO BE RESET TO CATCH UP. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 383 MG/DL AND CURRENT LEVEL WAS 255 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Nausea

  MAUDE report 10293109 ↗
• MalfunctionJul 15, 2020Mechanical Problem; Battery Problem; Power Problem; Mechanical Problem; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BATTERY WAS NON RESPONSIVE. CUSTOMER REPORTED THAT THE BATTERY WAS DIMINISHED LIFE AND REWIND TAKE LONGER TIME. 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 10274465 ↗
• MalfunctionJul 13, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD NO INSULIN DELIVERY ALARMS. 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 10262842 ↗
• MalfunctionJul 8, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS WERE HARDER TO PUSH. CUSTOMER STATED THAT THE INSULIN PUMP REJECTED NEW BATTERY AND REWINDS MORE THAN ONCE PER PRIME AND CRACK ACROSS THE SCREEN AND ALSO SLOWER TO REWIND AND ALSO HAD NO DELIVERY 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 10243872 ↗
• MalfunctionJul 8, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE STICKY AND UNRESPONSIVE. CUSTOMER STATED THAT INSULIN PUMP'S SCREEN WERE SCRATCHED. INSULIN PUMP RECEIVED UNEXPLAINED NO DELIVERY ALARM AND WAS REJECTING 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 10243870 ↗
• MalfunctionJul 8, 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 BUTTONS OF INSULIN PUMP WERE UNRESPONSIVE. THE INSULIN PUMP HAD LOUDER REWIND AND RANDOM NO DELIVERY ALERT. 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 10243749 ↗
• MalfunctionJul 8, 2020Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP FAILED BATTERY TEST, HAD LOST SETTINGS ON THE INSULIN PUMP AFTER CHANGING OUT BATTERIES, HAD RANDOM NO DELIVERY ALARMS, SCREEN HAD SCRATCHES AND THE INSULIN PUMP WAS SQUIRING OUT INSULIN WHILE 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 10243491 ↗
• MalfunctionJul 2, 2020Device Alarm System; Date/Time-Related Software Problem; Device Alarm System; Date/Time-Related Software Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS OFF TIME. CUSTOMER STATED THAT INSULIN PUMP WAS NOT VIBRATING OR BEEPING ON ANY NOTIFICATION. CUSTOMER PASSED SELF TEST FOR SOUND ANOMALY. 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 10222672 ↗
• MalfunctionJul 1, 2020Device Difficult to Program or Calibrate; Battery Problem; Insufficient Device Problem Information; Device Difficult to Program or Calibrate; Battery Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT ACT AND ESCAPE BUTTONS WERE HARDER TO PUSH. CUSTOMER REPORTED THAT INSULIN PUMP HAD ERROR MESSAGE, RANDOM NO DELIVERY ALARMS, CHANGING OUT BATTERIES EVERY 4 DAYS. 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 10217183 ↗
• InjuryJun 30, 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. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 430 MG/DL AND 267 MG/DL WHICH WAS TREATED WITH MANUAL INJECTION. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM NOR ADMITTED INTO HOSPITAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10211284 ↗

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-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-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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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