Paradigm® REAL-Time Revel™ MMT-523LNAH (UDI 00643169513839)Recalls & reported problems

Summary

The FDA's MAUDE database contains 443 adverse event reports that list this exact device (DI 00643169513839), received between May 29, 2017 and Dec 13, 2023 — classified as 4 deaths, 214 injuries, 225 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (59 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 443 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2023Material Integrity Problem; Material Integrity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED DAMAGE TO BATTERY CAP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DISCONTINUED THE USE OF THE DEVICE AND WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315872 ↗
• MalfunctionAug 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DRIVE SUPPORT CAP ON THEIR INSULIN PUMP WAS DAMAGE. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10389276 ↗
• MalfunctionAug 7, 2020Failure to Cycle; Mechanical Problem; Failure to Cycle; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND WAS STUCK IN THE REWIND MODE. 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 10378002 ↗
• MalfunctionJul 29, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10342099 ↗
• MalfunctionJul 24, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACKS AND PIECES OF PLASTIC MISSING BY RESERVOIR COMPARTMENT. 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 10319308 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 440 MG/DL. THE CUSTOMER WAS TREATED WITH THE MANUAL INJECTION, INSULIN PEN. THE CUSTOMER BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, AS A RESULT OF HIGH BLOOD GLUCOSE. IT WAS STATED THAT THE DRIVE SUPPORT CAP WAS APPEARED NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10268878 ↗
• MalfunctionJul 1, 2020Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERRORS AND THE BATTERY LIFE WAS DETERIORATING QUICKLY. 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 10216855 ↗
• MalfunctionJun 23, 2020Failure to Cycle; Mechanical Problem; Failure to Cycle; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DEVICE WAS SQUIRTING INSULIN OUT DURING MANUAL PRIME PROCESS. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARMS. CUSTOMER REPORTED INSULIN PUMP DID REQUIRE REWIND. CUSTOMER NOT ABLE TO COMPLETE 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 10183881 ↗
• MalfunctionJun 23, 2020Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS DIED IN THE MIDDLE IF NIGHT WITH NO WARNING. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS CRACK ON SIDE NEAR RESERVOIR AND BATTERY LASTING ABOUT MONTH. 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 10183194 ↗
• MalfunctionJun 10, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE KEYPAD OF INSULIN PUMP WAS NOT WORKING PROPERLY. THE CUSTOMER STATED THAT THE BUTTONS WERE HARDER TO PRESS. 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 10137403 ↗
• MalfunctionJun 5, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE KEYPAD WAS LOCKED. CUSTOMER STATED THAT SHE WAS TRYING TO HOLD THE B BUTTON AND THE UP ARROW AND IT WAS NOT UNLOCKING. 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 10122188 ↗
• InjuryMay 26, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 567 MG/DL. THE CUSTOMER WAS TREATED WITH BOLUS. CUSTOMER REPORTED THAT INSULIN PUMP RECEIVED NO DELIVERY ALARM. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10086642 ↗
• MalfunctionMay 8, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. DRIVE SUPPORT CAP WAS NORMAL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWOUND. 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 10038107 ↗
• MalfunctionMay 4, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION INDICATED BY MEDTRONIC THAT THE ACT BUTTON WAS HARDER TO PRESS AND PLASTIC HAD CHIPPED OFF THE RESERVOIR RIM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT COMPLETED AS ATTEMPTS TO CONTACT THE CUSTOMER WERE UNSUCCESSFUL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020056 ↗
• MalfunctionApr 27, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT WORKING. THE CUSTOMER ALSO STATED THAT THE BUTTONS WERE NOT WORKING ANYMORE AND THEY HAD TO PRESS THEM VERY HARD TO GET THEM TO WORK. THE CUSTOMER ALSO 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 10001948 ↗
• MalfunctionApr 20, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARED NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9976706 ↗
• MalfunctionApr 20, 2020Electrical /Electronic Property Problem; Device Difficult to Program or Calibrate; Electrical /Electronic Property Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PUMP ERROR ALARM AND THE ACT BUTTON WAS NOT WORKING. CUSTOMER STATED THAT THE TIME CLOCK 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 9976341 ↗
• MalfunctionMar 31, 2020Failure to Cycle; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Failure to Cycle; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD RAINBOW EFFECT, BACKLIGHT WAS NOT WORKING, HAVING DEPLETED LIFE, INSULIN WAS SQUIRTING DURING PRIME AND BUTTONS WERE HARD TO PRESS. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908870 ↗
• MalfunctionMar 31, 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 CUSTOMER'S BLOOD GLUCOSE WAS 250 MG/DL AT THE TIME OF INCIDENT. THE DEVICE WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM AND THE DRIVE SUPPORT CAP APPEARED TO BE 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 9902429 ↗
• MalfunctionMar 2, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD ACT BUTTON WAS STICKING. THE CUSTOMER STATED THEY OBSERVED TIME CLOCK 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 9773485 ↗
• MalfunctionFeb 27, 2020Display or Visual Feedback Problem; Battery Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S DISPLAY WAS DIFFICULT TO READ DUE TO SCRATCHES. BATTERY WAS LASTING FOR SIX 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 9762308 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 492 MG/DL AT THE TIME OF INCIDENT. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION AND INSULIN PUMP FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER DID NOT ALLEGE PUMP WAS UNDER DELIVERING. CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9762202 ↗
• MalfunctionFeb 21, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE LETTERS WERE HARDER TO READ WHEN TRYING TO TURN THE BACKGROUND LIGHT ON LIGHT DIMMER. 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 9738172 ↗
• MalfunctionFeb 13, 2020Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT SOMETIMES REWIND FEATURE OF INSULIN PUMP DID NOT WORK AND THEY WOULD NOT REWIND ALL THE WAY AND THEY HAD TO REDO PROCESS AGAIN. CUSTOMER STATED THAT THE INSULIN PUMP HAD CRACK ON BATTERY AREA. CUSTOMER STATED THAT THE BATTERIES LASTED 6 DAYS WHEN THEY PUTTING NEW BATTERY. CUSTOMER STATED THAT THEY WERE OFF FROM INSULIN PUMP FOR MORE THAN SIX MONTHS. 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 9705010 ↗
• MalfunctionFeb 11, 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9691674 ↗

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-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• 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-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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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