Paradigm® REAL-Time Revel™ MMT-523LNAS (UDI 00643169151314)Recalls & reported problems

Summary

The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 00643169151314), received between May 12, 2017 and Jan 25, 2021 — classified as 85 injuries, 189 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (53 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 274 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S RESERVOIR COMPARTMENT WAS CHIPPED AND THERE WAS MISSING PIECES. 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 11222102 ↗
• InjuryAug 14, 2020No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 400 MG/DL. CUSTOMER STATED THAT THE BATTERY COMPARTMENT WAS DAMAGE AND CRACK BATTERY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10405940 ↗
• MalfunctionJul 31, 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 STATED THAT 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 10348632 ↗
• MalfunctionJul 28, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARMS. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS NOT ABLE TO COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331074 ↗
• MalfunctionJul 8, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE TIME CLOCK ADVANCES. 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 10243784 ↗
• MalfunctionJun 18, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER HAD TO HOLD ACT BUTTON DOWN TO RESPOND. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD BATTERY LIFE WAS SIX DAYS OR LESS, REJECTED NEW BATTERIES AND REWINDS SLOWER. 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 10166367 ↗
• InjuryMay 29, 2020Mechanical Problem; Mechanical Problem

  CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE LEVEL OF 456 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER STATED THAT INSULIN PUMP HAD MOTOR ERROR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10100189 ↗
• InjuryMay 19, 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 HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 514 MG/DL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10073491 ↗
• InjuryMay 19, 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 LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 563 MG/DL. CUSTOMER REPORTED NO DELIVERY ALARM. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10069646 ↗
• MalfunctionMay 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BOTTOM OF THE INSULIN PUMP WAS COMING OFF. 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 10060554 ↗
• MalfunctionMay 11, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTON ISSUE. 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 10042549 ↗
• MalfunctionMay 7, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

  CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP ALARMED WITH UNEXPECTED RESTART. A COLD RESET WAS PERFORMED AND EXTERNAL RAM CRC ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS ABLE TO COMPLETE REWIND FOR UNEXPECTED RESTART. IT WAS CONFIRMED CUSTOMER WAS GETTING ALARMS WHEN CHANGING THE BATTERIES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10031803 ↗
• MalfunctionMay 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WERE NOT RESPONDING AND TIME CLOCK DID NOT ADVANCES. 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 10028821 ↗
• MalfunctionApr 21, 2020Display or Visual Feedback Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED REWINDING ANOMALY. CUSTOMER BLOOD GLUCOSE READING WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9984096 ↗
• MalfunctionMar 25, 2020Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ANOMALY. INSULIN PUMP HAD BATTERY OUT LIMIT ALARM AND ALSO REPORTED THAT ACT BUTTON WAS NOT WORKING. 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 9876486 ↗
• InjuryMar 23, 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 LEVEL WAS 500 MG/DL. CUSTOMER STATED THAT SELF TEST WAS PASSED. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9864671 ↗
• MalfunctionMar 20, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WERE CRACKS WHERE THEY PUT THE RESERVOIR AND ON THE RESERVOIR CHAMBER, PIECE OF RUBBER CAME OFF OF RUBBER RING AND A LITTLE SLOWER TO 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 9858456 ↗
• MalfunctionMar 19, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS STUCK ON PRIMING. CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. 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 9851965 ↗
• MalfunctionMar 16, 2020Material Integrity Problem; Patient Device Interaction Problem; Material Integrity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT BATTERY CAP POPPED OFF AND IT DIDN'T STAY IN ANY LONGER. THE CUSTOMER STATED THAT THE PIECE WAS MISSING AND THE TOP OF THE BATTERY COMPARTMENT POPPED 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 9834398 ↗
• MalfunctionMar 16, 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 COMPROMISED FORCE SENSOR SYSTEM ERROR. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9833808 ↗
• MalfunctionMar 13, 2020Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. CUSTOMER STATED THE INSULIN PUMP WAS DAMAGED. 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 9832077 ↗
• MalfunctionFeb 10, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER CONFIRMED THAT THE TIME ADVANCED. 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 9685924 ↗
• MalfunctionJan 30, 2020Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS WERE LESS RESPONSIVE AND BUTTONS WERE HARDER TO PRESS AND SOMETIMES HAD TO PRESS BUTTONS TWICE. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP WAS SLOWER AND LOUDER DURING REWIND AND DISPLAY LIGHT WAS 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 9646533 ↗
• MalfunctionJan 19, 2020Material Integrity Problem; Patient Device Interaction Problem; Material Integrity Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS CRACK ON THE INSULIN PUMP¿S SCREEN AND IT WAS REALLY DIFFICULT TO READ. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE BATTERY CAP WAS STRIPPED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9605015 ↗
• MalfunctionJan 6, 2020Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WAS STUCK IN REWIND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THEY DID NOT RECEIVE 2ND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9550352 ↗

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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-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