Paradigm® REAL-Time Revel™ MMT-523LNAL (UDI 00643169513846)Recalls & reported problems

Summary

The FDA's MAUDE database contains 841 adverse event reports that list this exact device (DI 00643169513846), received between May 31, 2017 and Jul 31, 2023 — classified as 3 deaths, 345 injuries, 493 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (125 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 841 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THAT WHEN CHANGING THE BATTERY AND NOTICE THAT IT WAS HARD TO LOCK AND ALSO SEE A CRACK AT THE TOP OF THE BATTERY COMPARTMENT. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17422424 ↗
• MalfunctionJul 18, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15039768 ↗
• 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 BUTTON ERROR AND BUTTONS UNRESPONSIVE. CUSTOMER STATED THE INSULIN PUMP HAD SLOWER TO REWIND AND 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 10390363 ↗
• MalfunctionAug 5, 2020Mechanical Problem; Visual Prompts will not Clear; Mechanical Problem; Visual Prompts will not Clear

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS STUCK IN REWIND PROCESS. THE CUSTOMER REPORTED THAT THEY WERE TRYING CHANGING THE RESERVOIR AND COULD NOT GET OUT OF THE REWIND PROCESS ONCE THEY REWOUND IT, IT ASKED TO REWIND AGAIN. 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 10371412 ↗
• MalfunctionJul 26, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  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 DRIVE SUPPORT CAP WAS NORMAL AND PRESSING THE CAP WHILE DID NOT CONNECTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10324616 ↗
• MalfunctionJul 24, 2020Computer Software Problem; Mechanical Problem; Computer Software Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND ALSO INSULIN DELIVERY STOPPED TEMPORARILY. CUSTOMER STATED THEY WERE UNABLE TO CLEAR THE ALARM AND THEY WERE UNABLE TO REWIND INSULIN PUMP. CUSTOMER STATED DRIVE SUPPORT CAP WAS PROTRUDED. 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 10319142 ↗
• MalfunctionJul 23, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ERROR 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 10313066 ↗
• MalfunctionJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA CALL THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL OF 30 MG/DL. CUSTOMER HAD BLOOD GLUCOSE LEVEL OF 387 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK, UNOMED-UNK.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10256546 ↗
• MalfunctionJul 9, 2020Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED WITH AN UNSPECIFIED INSULIN PUMP ERRORS. THE CUSTOMER RECEIVED AS A OR E CODE A WEEK AGO. 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 10249357 ↗
• MalfunctionJul 7, 2020No Display/Image; Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem; No Display/Image; Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THE BATTERY WAS CHANGED MULTIPLE TIMES, BUT THE ISSUE WAS NOT RESOLVED. CUSTOMER STATED THERE WAS A CRACK ON THE INSULIN PUMP BY BATTERY CAP ISSUE WITH BATTERY CAP CONNECTIVITY. 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 10238902 ↗
• MalfunctionJul 1, 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. CUSTOMER REPORTED THAT THEY TRIED TO CLEAR IT. TIME WAS ADVANCING ON INSULIN PUMP. CUSTOMER WAS NOT ABLE TO CLEAR THE BUTTON ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10216348 ↗
• MalfunctionJun 16, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER HAD ISSUE IN SCROLLING NUMBERS. 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 10157355 ↗
• MalfunctionJun 16, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. 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: No Consequences Or Impact To Patient

  MAUDE report 10157231 ↗
• MalfunctionJun 11, 2020Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SUDDEN POWER DOWN. CUSTOMER STATED THAT THE INSULIN PUMP WAS SLOW TO REWIND. INSULIN PUMP REJECTED NEW BATTERIES. CUSTOMER HAD TO RESTART TO REWIND TO COMPLETE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY 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 10142537 ↗
• InjuryJun 9, 2020No Display/Image; Priming Problem; No Display/Image; Priming Problem

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER HAD HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 450 MG/DL. CUSTOMER HAD A TUBING DETACHMENT AND WOKE UP TO A BLOOD GLUCOSE OF 385 MG/DL. THE CUSTOMER ALSO STATED THAT, THE INSULIN PUMP HAD PRIME REWIND ANOMALY. THE INSULIN PUMP IS STUCK IN PRIME REWIND. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE CUSTOMER HAS A PUMP THAT IS NOT WORKING CORRECTLY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10132543 ↗
• MalfunctionMay 22, 2020Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP STOPPED WORKING AND HAD A FROZEN DISPLAY. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT TIME DID NOT ADVANCES. CUSTOMER MENTIONED THAT THEY WERE UNABLE TO PRESS ACT BUTTON DURING REWOUND PROCESS. 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 10081830 ↗
• MalfunctionMay 20, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS UNABLE TO COMPLETE INSULIN PUMP REWIND DUE TO INSULIN PUMP 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 10074549 ↗
• InjuryMay 15, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 557 MG/DL. CUSTOMER REPORTED THAT THE INSULIN WAS EXITED. CUSTOMER REPORTED INSULIN FLOW BLOCK ALARM. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10060461 ↗
• MalfunctionMay 14, 2020Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD LOW BATTERY ALARM AND UNEXPECTED RESTART ALARM. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWIND THE INSULIN PUMP. THE CUSTOMER PERFORMED THE TROUBLESHOOTING AND THE ALARM OCCURRED SHORTLY AFTER INSERTING THE 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 10055157 ↗
• MalfunctionMay 8, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT NO DELIVERY ALARM. CUSTOMER WAS INQUIRING WHETHER A NO DELIVERY ALARM INDICATED IF THEY RECEIVED AN INSULIN BOLUS. TROUBLESHOOTING/EDUCATION WAS COMPLETED CUSTOMER'S BLOOD GLUCOSE IS UNKNOWN. NO FURTHER INFORMATION PROVIDED. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10039773 ↗
• InjuryMay 7, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

  THE CUSTOMER REPORTED VIA PHONE CALL THAT EMERGENCY MEDICAL SERVICE WAS DISPATCHED TO CUSTOMER DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2020 WITH UNKNOWN BLOOD GLUCOSE. THE CUSTOMER ALSO REPORTED THAT THEY HAD PASSED OUT. THEY WERE TREATED WITH D50 THROUGH INTRAVENOUS. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THEY DID NOT ALLEGE THAT THE INSULIN PUMP WAS OVER DELIVERING. THE DRIVE SUPPORT CAP WAS NORMAL. THE OTHER BLOOD GLUCOSE LEVELS WERE IN 30 MG/DL AND 60 MG/DL. THE CUSTOMER ALSO REPORTED MULTIPLE INSULIN PUMP ERRORS. THE CUSTOMER WAS ABLE TO CLEAR THE ALARMS AND REWIND THE INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 10031766 ↗
• MalfunctionMay 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT LCD SCREEN AND RESERVOIR COMPARTMENT WAS CRACKED. CUSTOMER REPORTED THAT 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 10031582 ↗
• MalfunctionApr 29, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS BROKEN. CUSTOMER STATED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED IN THE INSULIN PUMP. 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 10012575 ↗
• InjuryApr 29, 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 THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S HIGH BLOOD GLUCOSE WAS 400 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10011420 ↗
• InjuryApr 27, 2020Excess Flow or Over-Infusion; Adverse Event Without Identified Device or Use Problem; Excess Flow or Over-Infusion; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. CUSTOMER BLOOD GLUCOSE READING WHILE ADMITTED WAS UNKNOWN. CUSTOMER ALSO THOUGHT THEY HAVE OVER DELIVERY ISSUE. CUSTOMER SAID THE DIABETIC KETOACIDOSIS ALMOST KILLED HER. TROUBLESHOOTING WAS NOT PERFORMED. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10001644 ↗

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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-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-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