Paradigm® REAL-Time Revel™ MMT-723NAP (UDI 00643169202382)Recalls & reported problems

Summary

The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 00643169202382), received between Jun 21, 2016 and Aug 25, 2023 — classified as 3 deaths, 60 injuries, 170 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (63 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 233 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2023Computer Software Problem; Computer Software Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED THE ERROR CODE OF SOFTWARE ERROR BAD POINTER, IMPOSSIBLE DEFAULT CASE, PARAMETER OUT OF RANGE, ETC. (A53). TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWIND THE PUMP SUCCESSFULLY. THE PUMP PASSED THE SELF-TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP AND THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17621403 ↗
• MalfunctionOct 22, 2020Moisture or Humidity Problem; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. CUSTOMER STATES THEY DO NOT HEAR FLUID WHEN SHAKING THE PUMP. CUSTOMER STATED THEY DID NOT SEE FLUID UNDER THE LCD. CUSTOMER STATED THE PUMP WAS NOT DROPPED. CUSTOMER STATED THERE WERE NO CRACKS IN THE 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 10716549 ↗
• MalfunctionAug 7, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARD TO PRESS. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT THE INSULIN PUMP CHIPPED NEAR BATTERY CAP AND MAKES IT DIFFICULT TO OPEN OR CLOSE. 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 10377827 ↗
• MalfunctionJul 19, 2020Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT ACT BUTTONS OF INSULIN PUMP HAD TO PUSH HARDER. CUSTOMER STATED THAT NEAR BATTERY CAP AREA WAS CRACK AND TOP RIGHT CORNER OF THE SCREEN WAS CRACK THAT GOES TO THE BACK OF THE INSULIN PUMP. 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 10293755 ↗
• MalfunctionJul 14, 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 STATED THAT, THE INSULIN PUMP HAD BUTTON 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 10270554 ↗
• MalfunctionJul 14, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTON OF INSULIN PUMP WAS STUCK AND THEY CAN NOT CLEAR THE 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 10270402 ↗
• MalfunctionJul 14, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER STATED THAT THE BUTTONS GETTING STUCK. CUSTOMER STATED THE ESC AND ACT DID NOT RESPOND AT ALL, AND THE ARROWS SOMETIMES RESPOND. CUSTOMER STATED THAT THE TIME CLOCK WAS 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 10269792 ↗
• MalfunctionJun 22, 2020Failure to Cycle; Priming Problem; Failure to Cycle; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10177870 ↗
• MalfunctionJun 17, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD NO DELIVERY ALARM. THE TROUBLESHOOTING WAS PERFORMED FOR THE NO DELIVERY ALARM. IT WAS STATED THAT THE CUSTOMER HAVE TRIED ALL THE REMEDIES. 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 10161306 ↗
• MalfunctionJun 6, 2020Device Alarm System; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Device Alarm System; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE STUCK. CUSTOMER STATED THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE, FAILED BATTERY TEST, UNEXPLAINED NO DELIVERY ALARMS AND LOW RESERVOIR ALARM NOT CONSISTENT. 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 10126414 ↗
• MalfunctionJun 4, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR AND THE BUTTONS WERE NOT WORKING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10117487 ↗
• InjuryMay 26, 2020Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 511 MG/DL. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD INSULIN FLOW BLOCK ALARM. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THEY HAD TRIED ALL REMEDIES. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10085848 ↗
• MalfunctionMay 12, 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 HYPERGLYCEMIA WITH BLOOD GLUCOSE OF 493 MG/DL AND WAS TREATED WITH MANUAL INJECTION. CUSTOMER STATED THAT THE PROBLEM WAS WITH INSULIN PUMP'S RESERVOIR. RESERVOIR DID GO TO NO DELIVERY AND CUSTOMER COULD NOT PLUNGE THE INSULIN THROUGH THE RESERVOIR. CUSTOMER ALSO STATED THAT ALARM DID NOT OCCUR DURING MANUAL PRIME AND RESOLVED BY AFTER COMPLETE SET CHANGED. INSULIN PUMP WILL RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10048050 ↗
• MalfunctionMay 11, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SCRATCHES ON SCREEN THAT MADE IT DIFFICULT TO READ AND RECEIVED MOTOR ERROR ALARMS FREQUENTLY. CUSTOMER STATED THAT THEY HAD TO PUSH BUTTONS HARDER TO RESPOND. CUSTOMER STATED THAT THE INSULIN PUMP HAD CRACK ON BOTTOM NEAR RESERVOIR OPENING AND WENT UP TOWARDS ACT BUTTON AS WELL AS PLASTIC ON RESERVOIR OPENING WAS CRACKED. 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 10043714 ↗
• MalfunctionMay 7, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Premature Discharge of Battery; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR. CUSTOMER REPORTED THAT THEY WERE UNABLE TO CLEAR THE ALARM. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD BUTTON ERROR. 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 10031663 ↗
• MalfunctionApr 29, 2020No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. THE CUSTOMER STATED INSULIN PUMP HAD ISSUES WITH THE BUTTONS FOR ABOUT 1 YEAR BUT THIS MORNING IT WAS NOT WORKING. 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 10008700 ↗
• MalfunctionApr 27, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARMS. CUSTOMER STATED THEY DID REWIND AND GOT A MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. THE INSULIN PUMP ALARM HISTORY HAD MORE THAN ONE MOTOR ERROR ALARM. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD A NO DELIVERY ALARM AND THE ALARM WAS RESOLVED BY CHANGING THE COMPLETE SET. 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 10000761 ↗
• MalfunctionApr 14, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR WHEN TRYING TO FILL THE TUBING. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9956262 ↗
• MalfunctionApr 8, 2020Use of Device Problem; Use of Device Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE WHEN HE CHANGED THE BATTERIES, IT ERASES THE SETTINGS. 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 9936875 ↗
• MalfunctionFeb 7, 2020Computer Software Problem; Power Problem; Patient Device Interaction Problem; Computer Software Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SHUT OFF AND BECOME UNRESPONSIVE. THE CUSTOMER STATED THAT INSULIN PUMP REJECTED NEW BATTERIES AND CRACK ON BATTERY COMPARTMENT, RESERVOIR AND SCREEN. CUSTOMER STATED THAT INSULIN PUMP RECEIVED ERROR CODE. 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 9680013 ↗
• MalfunctionFeb 6, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AFTER THE REWIND AND ALSO HAD MOTOR POSITION ENCODER ERROR. IT WAS ALSO REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER DID NOT REPORT MOTOR POSITION ENCODER ERROR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676382 ↗
• MalfunctionJan 27, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP WAS NOT ABLE TO TURN ON. CUSTOMER DROPPED THE INSULIN PUMP. CUSTOMER REPORTED NO VISIBLE PUMP DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9630740 ↗
• MalfunctionJan 16, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF INSULIN PUMP HAD TO BE PRESSED MULTIPLE TIMES AND HARDER BEFORE THEY RESPOND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UP TO 146 MG/DL. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE; HOWEVER IT WAS CHANGED. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD SCRATCH WENT DIAGONALLY FROM BOTTOM LEFT CORNER OF THE SCREEN TO UPPER RIGHT CORNER OF THE SCREEN, BATTERY CAP SLOT WAS WORN DOWN AND IT WAS HARD TO REMOVE AND ATTACH; HOWEVER IT WAS WORKING FINE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP REQUIRED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594607 ↗
• MalfunctionJan 9, 2020Failure to Cycle; Failure to Cycle

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME PROCESS. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9568769 ↗
• MalfunctionDec 17, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RANDOMLY RECEIVED MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORT THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR ALARM AND COMPLETE PUMP REWIND. THE INSULIN PUMP ALARM HISTORY ALSO CONTAINS A MOTOR POSITION ENCODER ERROR. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9484483 ↗

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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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