Paradigm® REAL-Time Revel™ MMT-723RNAL (UDI 00643169513129)Recalls & reported problems

Summary

The FDA's MAUDE database contains 772 adverse event reports that list this exact device (DI 00643169513129), received between Jun 6, 2017 and Jul 20, 2021 — classified as 4 deaths, 370 injuries, 398 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (95 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 772 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Moisture or Humidity Problem; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD EXPOSE TO FLUID. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12196261 ↗
• InjuryJul 20, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA, ON UNKNOWN DATE WITH UNKNOWN BLOOD GLUCOSE VALUE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR,UNOMED INF SET.

  Patient problems: Hyperglycemia

  MAUDE report 12194615 ↗
• MalfunctionFeb 23, 2021Mechanical Problem; Battery Problem; Moisture or Humidity Problem; Mechanical Problem; Battery Problem; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS EXPOSED TO FLUID AND HAD MOTOR ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO COMPLETE REWIND PROCESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 11364742 ↗
• MalfunctionAug 12, 2020Power Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP STOPPED WORKING. 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 10394574 ↗
• InjuryAug 4, 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 BLOOD GLUCOSE LEVELS OVER 500 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT WORKING PROPERLY EVEN AFTER ADJUSTING INSULIN CAUSING THEM HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10361175 ↗
• MalfunctionAug 3, 2020Device Alarm System; Failure to Cycle; Device Alarm System; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND ALSO HAD LOW RESERVOIR. 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 10354834 ↗
• InjuryJul 31, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 1400 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA AND VOMITING, DIARRHEA. THE CUSTOMER ALLEGES INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION AND INSULIN DRIP. THE CUSTOMER BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL-SLIGHTLY INDENTED. THE CUSTOMER PERFORMED HIGH PRESSURE TEST AND THEY WERE ABLE TO PASSED THE TEST. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Diarrhea; Hyperglycemia; Nausea; Vomiting

  MAUDE report 10348628 ↗
• InjuryJul 31, 2020Premature Discharge of Battery; Mechanical Problem; Connection Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Mechanical Problem; Connection Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT CUSTOMER DID NOT TREATED WITH A INTRAVENOUS DRIP. THE CUSTOMER THINKS THE PARAMEDICS DID NOT REMOVE THE INSULIN PUMP FROM BODY PROPERLY RESULTING IN DAMAGE TO THE INSULIN PUMP. ON (B)(6) 2020 THE CUSTOMER REPORTED THAT INSULIN PUMP RECEIVED AN UNEXPECTED RESTART ALARM AND CONTINUES TO EXPERIENCE MOTOR ERROR ALARMS.

  Patient problems: Hypoglycemia

  MAUDE report 10348525 ↗
• InjuryJul 27, 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 HAD A HIGH BLOOD GLUCOSE VALUE OF 400 MG/DL. CUSTOMER STATED THAT THE INFUSION SET HAD BENT CANNULA. CUSTOMER DECLINED TROUBLE SHOOT FOR HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10330635 ↗
• MalfunctionJul 24, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AN INSULIN FLOW BLOCK ALARM. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER MENTIONED THAT THE INSULIN EXITED AT THE TUBING AND THE INSULIN PUMP ALARMED TOO. 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 10319299 ↗
• MalfunctionJul 24, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALERTS AS WELL AS ACT BUTTONS WAS TO HARDER TO PRESS. 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 10319002 ↗
• InjuryJul 22, 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 LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 548 MG/DL AT THE TIME OF THE INCIDENT. ANOTHER BLOOD GLUCOSE LEVEL WAS 500 MG/DL. THE CUSTOMER STATED THAT THE INFUSION SET WAS FALLING OFF DUE NO ADHESIVE TAPE ON IT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10306714 ↗
• MalfunctionJul 22, 2020Power Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REPLACE BATTERY ALERT. THE CUSTOMER STATED THEY DID NOT RECEIVE LOW BATTERY ALERT PRIOR TO THE REPLACE BATTERY ALERT. CUSTOMER STATED THAT THIS WAS THE SECOND OCCURRENCE OF REPLACE BATTERY ALERT WITHOUT A LOW BATTERY WARNING. 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 10306395 ↗
• InjuryJul 21, 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 WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL ON (B)(6) 2020. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 232 MG/DL. CUSTOMER WAS UNCONSCIOUS. CUSTOMER WAS TREATED WITH INSULIN DRIP. CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL OF 46 MG/DL. CUSTOMER WAS TREATED WITH FOOD AND BLOOD GLUCOSE RISES TO 63 MG/DL. CUSTOMER DID NOT ALLEGE INSULIN PUMP FOR UNDER DELIVERING. CUSTOMER STATED THAT THEY DID SELF TEST AND IT WAS PASSED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia; Loss of consciousness

  MAUDE report 10300821 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD CRACK ON THE SCREEN. BELT CLIP WAS DAMAGED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10294166 ↗
• MalfunctionJul 20, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. THE CUSTOMER STATED THAT ACT BUTTON STOPPED 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 10294158 ↗
• MalfunctionJul 20, 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 INSULIN PUMP HAD MOTOR ERROR AND BUTTON ERROR. THE INSULIN PUMP HAD LOUDER REWIND AND RANDOM NO DELIVERY 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 10294024 ↗
• MalfunctionJul 17, 2020Obstruction of Flow; Priming Problem; Obstruction of Flow; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALERTS FREQUENTLY. CUSTOMER STATED THAT INSULIN SQUIRTING DURING PRIMING PROCESS. 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 10287902 ↗
• InjuryJul 16, 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. BLOOD GLUCOSE READING WENT BETWEEN 300 MG/DL TO 600 MG/DL AND CUSTOMER¿S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 370 MG/DL. CUSTOMER FEEL OKAY TO TROUBLESHOOT. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS TREATED FOR THEIR HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER PERFORMED HIGH PRESSURE TEST AND IT WAS PASSED. CUSTOMER STATED THAT CANNULA OF INFUSION SET WAS BENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM NOR ADMITTED INTO HOSPITAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10287224 ↗
• MalfunctionJul 16, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE 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 10281543 ↗
• MalfunctionJul 14, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS MISFIRED AND TRIED TO GIVE 22 UNITS INSTEAD OF 2 UNITS OF BOLUS. 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 10270371 ↗
• InjuryJul 13, 2020Failure to Cycle; No Apparent Adverse Event; Failure to Cycle; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 600 MG/DL. THE CUSTOMER REPORTED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR ALARM. DRIVE SUPPORT CAP WAS NORMAL. INSULIN PUMP WAS NO LONGER WORKING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10264097 ↗
• MalfunctionJul 10, 2020Premature Discharge of Battery; Loss of Data; Inappropriate or Unexpected Reset; Premature Discharge of Battery; Loss of Data; Inappropriate or Unexpected Reset

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEIR INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERRORS ALARMS. CUSTOMER WERE ABLE TO CLEAR ALARMS AND ABLE TO COMPLETE REWIND THE INSULIN PUMP. CUSTOMER REPORTED THAT THE AFTER INSERTING A NEW BATTERY THEY RECEIVED 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 10256503 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER'S HUSBAND REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED FOR THE UNKNOWN REASON. CUSTOMER HAD STROKE AND THEY NEED TO FIND OUT HOW MUCH INSULIN SHE GAVE HERSELF. CUSTOMER GAVE HERSELF SEVERAL BOLUSES IN ONE DAY ONLY ONCE USING THE BOLUS WIZARD. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10256274 ↗
• MalfunctionJul 9, 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 10249480 ↗

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-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-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-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-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