Paradigm® REAL-Time Revel™ MMT-723RNAP (UDI 00643169513136)Recalls & reported problems

Summary

The FDA's MAUDE database contains 758 adverse event reports that list this exact device (DI 00643169513136), received between Jun 1, 2017 and May 6, 2021 — classified as 6 deaths, 366 injuries, 386 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (97 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 758 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2021Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS CRACKED THROUGH THE SCREEN CAUSING A BLACK SHADOW MARK ACROSS THE IT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 11783445 ↗
• MalfunctionOct 5, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS CORRECT. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NO DROPPED OR BUMPED. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP 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 10625206 ↗
• MalfunctionSep 18, 2020Moisture or Humidity Problem; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP EXPOSED TO MOISTURE IN SWIMMING POOL. 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 10552513 ↗
• MalfunctionAug 14, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR MULTIPLE TIMES AND INSULIN PUMP WAS ABLE TO REWIND THE INSULIN PUMP. 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 10406607 ↗
• InjuryAug 14, 2020Mechanical Problem; Detachment of Device or Device Component; No Apparent Adverse Event; Mechanical Problem; Detachment of Device or Device Component; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WERE OVER 400 MG/DL, 43 MG/DL AND OTHER VALUE WAS 323MG/DL. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND THE DRIVE SUPPORT CAP WAS FLUSHED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10406153 ↗
• MalfunctionAug 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR DID LOCK IN PLACE INTO THE INSULIN PUMP. THE CUSTOMER ALSO STATED THAT THE RESERVOIR LIP RING AND COMPARTMENT WERE CRACKED. 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 10377637 ↗
• MalfunctionAug 6, 2020Display or Visual Feedback Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S SCREEN HAD DEEP SCRATCHES WHICH PREVENT THEM TO SAW THE SCREEN. INSULIN PUMP RECEIVED BAD BATTERY ALERT EVEN WITH NEW BATTERIES. CUSTOMER DECLINED TO TROUBLESHOOTING FOR FURTHER ISSUE. 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 10372152 ↗
• MalfunctionAug 6, 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 10371547 ↗
• MalfunctionAug 4, 2020Premature Discharge of Battery; Use of Device Problem; Premature Discharge of Battery; Use of Device Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED RESET ALARM AND UNEXPECTED POWER LOSS ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO REWIND 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 10362229 ↗
• MalfunctionAug 4, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS, RECEIVED RANDOM NO DELIVERY ALARM AND THE PLASTIC AROUND THE BATTERY CAP WAS BROKEN. 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 10361145 ↗
• InjuryAug 4, 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 LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 45 MG/DL WHICH WAS TREATED WITH FOOD. THE CUSTOMER ALSO STATED THAT THEY DID NOT ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER STATED THAT LOW BLOOD GLUCOSE DUE TO ACTIVE INSULIN WAS CLEARED FROM UNEXPECTED RESTART ALARM. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM NOR ADMITTED INTO HOSPITAL. CUSTOMER WAS DECLINED TROUBLESHOOT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10360544 ↗
• MalfunctionJul 31, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE REWIND PROCESS. CUSTOMER STATED THAT THEY CHANGE BATTERY AND INSULIN PUMP AGAIN ALARMED UNEXPECTED RESTART 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 10349328 ↗
• MalfunctionJul 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MULTIPLE TIMES AFTER BATTERY CHANGE WITH UNEXPECTED RESTART. A COLD RESET WAS PERFORMED. THE CUSTOMER'S BLOOD GLUCOSE WAS 197 MG/DL AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10342963 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 385 MG/DL AT THE TIME OF INCIDENT AND OTHER BLOOD GLUCOSE VALUE WAS IN THE RANGE OF 500 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH INJECTION. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10336762 ↗
• MalfunctionJul 28, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD 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 10331216 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE NOT RESPONDING. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP WAS NOT REWINDING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10293990 ↗
• MalfunctionJul 17, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP NEEDED TO BE REPLACED DUE TO CRACKS IN CASING. NO FURTHER DETAILS WERE PROVIDED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10291971 ↗
• MalfunctionJul 15, 2020No Display/Image; Obstruction of Flow; Material Integrity Problem; No Display/Image; Obstruction of Flow; Material Integrity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY INSULIN PUMP HAD BLANK DISPLAY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER RECEIVED NO DELIVERY ALARM BUT THEN DID NOT TURN BACK ON. CUSTOMER STATED THAT INSULIN PUMP WAS NOT EXPOSED TO MOISTURE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND CUSTOMER REPORTS DISPLAY WAS BLANK CURRENTLY. CUSTOMER STATED THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. THE CUSTOMER REMOVES THE BATTERY AND STATED THE INSERT BATTERY ALARM DID NOT DISPLAY ON THE INSULIN PUMP SCREEN. CUSTOMER STATED THE CONTACT ON THE BATTERY CAP WAS NEITHER MISSING NOR DAMAGE, ONLY THE COIN SLOT OF THE BATTERY CAP WAS WORN OUT. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE SPRING WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THAT DISPLAY DID NOT RETURNED AFTER INSULIN PUMP RESTART. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10281097 ↗
• MalfunctionJul 14, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS UNDER DELIVERING INSULIN AND CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 368 MG/DL. CUSTOMER STATED THAT THEY TOOK 3 TO 4 CORRECTIONS AND IT KEPT GOING UP AND GOT NO DELIVERY AFTER SUPPER AND CHANGED OUT ENTIRE SITE. CUSTOMER STATED WAS GETTING HIGH BLOOD SUGARS WHICH KEPT RISING AFTER BLOUSING WITH INSULIN PUMP. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED FOR HIGH BLOOD GLUCOSE WITH INJECTIONS. CUSTOMER WAS ALLEGING POSSIBLE INSULIN PUMP UNDER DELIVERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. UNOMED SET

  Patient problems: Hyperglycemia

  MAUDE report 10269704 ↗
• MalfunctionJul 13, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ERROR ALARM. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARED 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 10263896 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 432 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER HAD BLOOD GLUCOSE LEVELS OF 349 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10257091 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 432 MG/DL AND 349 MG/DL. CUSTOMER TREATED WITH 14 UNITS OF INSULIN. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10256691 ↗
• InjuryJul 8, 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. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 545 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER MENTIONED OTHER BLOOD GLUCOSE VALUE AS 380 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10244158 ↗
• MalfunctionJul 8, 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 WERE HARDER TO PRESS CAUSING ISSUES. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD RECEIVED FALSE OR UNEXPLAINED NO DELIVERY ALARMS AND DIMINISHED BATTERY LIFE NOT LESS THAN SEVEN 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 10243877 ↗
• MalfunctionJul 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED ERROR. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER ALSO REPORTED THAT ALARMED RECURRED AFTER INSERTING A NEW BATTERY. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10231835 ↗

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