Paradigm® REAL-Time Revel™ MMT-723LNAP (UDI 00643169513907)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,256 adverse event reports that list this exact device (DI 00643169513907), received between May 15, 2017 and Oct 16, 2023 — classified as 7 deaths, 548 injuries, 701 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (220 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 1,256 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2023Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CONSUMER EXPERIENCED HYPERGLYCEMIA, WITH A 333 MG/DL, GLUCOSE NUMBER, BECAUSE OF AN INSULIN FLOW BLOCKED ANOMALY CAUSED BY NO DELIVERY OR OCCLUSION ALARM BEING TRIGGERED AT RANDOM. TROUBLESHOOTING WAS PERFORMED AND IT WAS UNSURE IF THE INSULIN PUMP DEVICE WAS UTILIZED WITHIN 48 HOURS, AND WHETHER THE AUTO MODE OPTION WAS ACTIVATED OR NOT AT THE TIME OF THE OCCURRENCE. NO FURTHER CUSTOMER COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL CONTINUE THE USE OF THE INSULIN PUMP AND WILL NOT BE RETURNED FOR ANALYSIS, BUT THE RESERVOIR WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 17937864 ↗
• MalfunctionOct 5, 2023Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARM OF THE INSULIN FLOW BLOCKED OR NO DELIVERY WAS ASCRIBED TO A MOTOR ERROR; THERE WERE TWO MOTOR ERRORS, ONE OF WHICH WAS ABLE TO REWIND AND CLEAR THE ALARM, WHILE THE OTHER WAS UNABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 17875015 ↗
• MalfunctionOct 20, 2020Moisture or Humidity Problem; Patient Device Interaction Problem; Moisture or Humidity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACCIDENTALLY WENT SWIMMING WITH IT LAST WEEK AND THE SCREEN IS PEELING UP. 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 10703305 ↗
• MalfunctionOct 9, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE LEFT SIDE OF THE INSULIN PUMP'S SCREEN WAS CRACKED. CUSTOMER REPORTED COSMETIC DAMAGED TO THE INSULIN PUMP. THE RETAINER RING HAD NO PHYSICAL 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 10654320 ↗
• InjurySep 21, 2020Power Problem; No Apparent Adverse Event; Patient Device Interaction Problem; Power Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RANDOMLY SHUTS OFF AND NOT GIVING INSULIN. CUSTOMER'S PARENT STATES BATTERY COMPARTMENT AND/OR SPRING WAS DAMAGED OR CORRODED. CUSTOMER'S PARENT ALSO REPORTED THE CUSTOMER WAS HAVING KETONES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10564763 ↗
• MalfunctionSep 16, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM AND NO DELIVERY ALARM. THE CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE MOTOR ERROR ALARM AND 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 10539172 ↗
• MalfunctionAug 7, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND THEY DECLINED TO TROUBLESHOOT. 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 10377981 ↗
• MalfunctionAug 7, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCED SENSOR ALARM WHILE FILLING TUBING. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. THE FORCE SENSOR WAS NO LONGER DETECTING RESERVOIR DURING SEATING. NO HARM REQUIRING MEDICAL INTERVENTION WAS NOTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10377782 ↗
• InjuryAug 7, 2020No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 437 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD CRACK ON BATTERY COMPARTMENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10377495 ↗
• MalfunctionAug 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD ARROW BUTTONS UNRESPONSIVE. 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 10372705 ↗
• MalfunctionAug 6, 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 RECEIVED MOTOR ERROR AND DRIVE SUPPORT CAP WAS PROTRUDED. INSULIN DELIVERY WAS TEMPORARILY STOPPED. 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 10372441 ↗
• MalfunctionAug 5, 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 ALARM. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. 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 10366549 ↗
• MalfunctionJul 31, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE NOT WORKING PROPERLY. THE TIME ON THE INSULIN PUMP 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 10348743 ↗
• MalfunctionJul 31, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR 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 10348698 ↗
• InjuryJul 30, 2020Device Difficult to Program or Calibrate; No Apparent Adverse Event; Priming Problem; Device Difficult to Program or Calibrate; No Apparent Adverse Event; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 50 MG/DL AND OTHER BLOOD GLUCOSE WAS 46 MG/DL. THE CUSTOMER WAS TREATED WITH FOOD. THE CUSTOMER STATED BUTTONS WERE NOT RESPONDING. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER REPORTED THAT THEY DID NOT BELIEVE INSULIN PUMP WAS OVER-DELIVERING. THE CUSTOMER RECALLS INSULIN DRIPPING FROM END OF SET BEFORE CONNECTING AT THEIR SITE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10342647 ↗
• InjuryJul 29, 2020Device Difficult to Program or Calibrate; Date/Time-Related Software Problem; Device Difficult to Program or Calibrate; Date/Time-Related Software Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE AND INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 50 MG/DL AT THE TIME OF INCIDENT AND OTHER BLOOD GLUCOSE VALUE WAS 46 MG/DL. CUSTOMER REPORTED THAT THE BUTTONS OF INSULIN PUMP WERE NOT RESPONDING. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF LOW BLOOD GLUCOSE. CUSTOMER REPORTED THAT THEY DID NOT ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER TREATED WITH FOOD. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10337405 ↗
• InjuryJul 29, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA AND BUTTONS WERE NOT WORKING. CUSTOMER STATED THAT BLOOD GLUCOSE VALUE WAS 50 MG/DL AND 46 MG/DL. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER HAD TO PRESS THE BUTTON 20 TIMES TO GET IT TO WORK. CUSTOMER DID NOT ALLEGE PUMP WAS OVER DELIVERING. DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10337300 ↗
• InjuryJul 29, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING LOW BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 50 MG/DL, 46 MG/DL. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER STATED INSULIN PUMP BUTTONS WERE NOT WORKING AND ALSO TIME CLOCK ANOMALY. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10336763 ↗
• 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 INSULIN PUMP ERROR. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. CUSTOMER EXPERIENCED MULTIPLE INSULIN PUMP ERROR ALARMS AFTER A BATTERY CHANGE. 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 10331593 ↗
• MalfunctionJul 28, 2020Premature Discharge of Battery; Inappropriate or Unexpected Reset; Premature Discharge of Battery; Inappropriate or Unexpected Reset

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER STATED THE THAT THEY RECEIVED UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED. CUSTOMER COULD CLEAR THE ALARM HOWEVER AFTER TROUBLESHOOTING CUSTOMER STILL RECEIVED GENERAL UNEXPECTED RESTART. 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 10331179 ↗
• MalfunctionJul 27, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND. CUSTOMER DID NOT REPORT AN MOTOR POSITION ENCODER ERROR ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP 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 10324712 ↗
• MalfunctionJul 24, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ERROR ALARM. CUSTOMER WAS UNABLE TO CLEAR 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 10318587 ↗
• MalfunctionJul 23, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER DID NOT REPORTED THE HISTORY OF MOTOR AND MOTOR PISTON ENCODE ERROR ALARMS. 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 10315936 ↗
• MalfunctionJul 22, 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'S BUTTONS WERE HARDER TO PRESS. CUSTOMER STATED THE INSULIN PUMP HAD SMALL CRACK ON THE CORNER OF SCREEN AND RAINBOW EFFECT ON SCREEN. 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 10307180 ↗
• InjuryJul 21, 2020Moisture or Humidity Problem; Moisture or Humidity Problem

  CUSTOMER REPORTED VIA PHONE THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL 600 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. TROUBLESHOOTING WAS DECLINED BY THE CUSTOMER FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WENT TO DOCTOR AND FOUND INSULIN DRIPPED OUT OF THE PUMP. CUSTOMER STATED THAT FLUID FOUND IN RESERVOIR COMPARTMENT AND O RING WAS IN PLACE. SELF TEST WAS PASS. DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10300797 ↗

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