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Paradigm® REAL-Time Revel™ MMT-723LNAB (UDI 00643169151321)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-723LNAB PRDGM INS V2.5 BL EN LN · Class 3

All models of Paradigm REAL-Time Revel (180)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Medtronic Paradigm REAL-Time Revel insulin pump has 191 reports, 67 injuries and 2 deaths. Many reports describe the pump showing incorrect messages, buttons that do not respond, or a frozen or blank screen, and some describe cracks or battery alarms. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
191
Deaths reported
2
Injuries reported
67
Recalls naming it
0

Summary

The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 00643169151321), received between Jun 5, 2014 and Jul 8, 2020 — classified as 2 deaths, 67 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (55 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

Device problems

  • Device Displays Incorrect Message55
  • Device Difficult to Program or Calibrate29
  • Mechanical Problem23
  • Patient Device Interaction Problem22
  • No Display/Image17
  • Obstruction of Flow17
  • Adverse Event Without Identified Device or Use Problem16
  • Power Problem16

Patient problems

  • No Consequences Or Impact To Patient117
  • Hyperglycemia60
  • Hypoglycemia18
  • Death2
  • Elevated Ketones/ Diabetic Ketoacidosis1

Recent adverse event reports

The 25 most recent of 191 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 8, 2020Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Power Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Power Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER STATED THAT HE FELL IN THE LAKE AND THE INSULIN PUMP WENT IN WITH HIM AND NOW THE INSULIN PUMP WAS NOT WORK PRESSES ACT BUT NOTHING HAPPENS AND THE SCREEN FREEZES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATES THE PUMP ALARMED AFTER BATTERY CHANGE. CUSTOMER RECEIVED BATTERY OUT LIMIT. CUSTOMER REPORTED THEY WERE UNABLE TO CLEAR THE ALARM. INSULIN PUMP WAS EXPOSED TO MOISTURE. CUSTOMER STATED THE INSULIN PUMP WAS NOT DROPPED. CUSTOMER STATED THERE ARE NOT CRACKS IN THE INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10243523 ↗
  • MalfunctionJul 3, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD STUCK BUTTON ERROR. THE TROUBLESHOOTING WAS PERFORMED FOR THE STUCK BUTTON ERROR. THE CUSTOMER STATED THAT THEY RECEIVED THE BUTTON ERROR AND NONE OF THE BUTTONS WERE WORKING. THE CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND FOUND THAT IT 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 10229181 ↗
  • MalfunctionMay 13, 2020Visual Prompts will not Clear; Power Problem; Visual Prompts will not Clear; Power Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD FROZEN DISPLAY AND BATTERY OUT LIMIT ALARM. THE CUSTOMER WAS UNABLE TO CLEAR ALARM. CUSTOMER WAS TRYING TO CLEAR THE ALARM BUT, HIS DOWN BUTTON WOULD NOT RESPOND AND TIME WAS NOT ADVANCING SO INSULIN PUMP WAS FROZEN. CUSTOMER WENT TO TROUBLESHOOT FOR FROZEN SCREEN. 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 10050605 ↗
  • MalfunctionMay 13, 2020Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT ESCAPE AND ACT BUTTONS OF THE INSULIN PUMP WERE NOT RESPONDING TO PRESSED. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD BATTERY OUT LIMIT ALARM AND THE ALARM COULD NOT BE CLEARED. 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 10050601 ↗
  • MalfunctionMay 9, 2020Mechanical Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Patient Device Interaction Problem; Priming Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A CRACK TO THE CORNER OF THE SCREEN TOWARDS THE BATTERY COMPARTMENT. 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 10041153 ↗
  • MalfunctionApr 13, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND CRACK ON BATTERY COMPARTMENT. 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 9954128 ↗
  • MalfunctionApr 13, 2020Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP JUST KEEPS BEEPING WHEN PRESSING A BUTTON BUT NOTHING HAPPEN AND ARE NOT RESPONDING AND THE INSULIN PUMP WAS NOT WORKING. CUSTOMER STATED THAT THE TIME CLOCK 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 9952099 ↗
  • MalfunctionMar 23, 2020Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCREEN HAD NUMEROUS SCRATCHES AND HAD TO TILT THE SCREEN TO READ AND THE LEFT PART OF THE SCREEN WAS BLACK MAKING IT DIFFICULT TO READ. CUSTOMER STATED THAT THE PLASTIC PIECES CHIPPED OFF WHILE CHANGING OUT RESERVOIR PORT RINGS, HAD CRACKS AROUND THE BATTERY PORT, FAILED BATTERY TEST AND MOTOR WAS LOUDER DURING REWOUND. CUSTOMER STATED INSULIN PUMP SHOOTS INSULIN DURING PRIMING AND THE BUTTONS WERE 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 9865833 ↗
  • MalfunctionMar 20, 2020Failure to Cycle; Failure to Cycle

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. 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 9858949 ↗
  • InjuryMar 5, 2020Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER RECEIVED EMERGENCY ROOM DUE TO HYPOGLYCEMIA ON (B)(6) 2020. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 30 MG/DL AT THE TIME OF HOSPITALIZED. CUSTOMER STATED THAT THEY TREATED FOR LOW BLOOD GLUCOSE VALUE WITH SUGAR SOLUTION THROUGH INTRAVENOUS AND THEN AFTER THAT, CHECKED BLOOD GLUCOSE AND IT WAS 31 MG/DL. CUSTOMER DECLINED TO TROUBLESHOOT FOR THE LOW BLOOD GLUCOSE AND NO DELIVERY ALARM AS THE RESERVOIR WAS EMPTY. CUSTOMER ALSO STATED THAT INSULIN PUMP RECEIVED MOTOR ERROR ALARM AND THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD AND THE DISPLACEMENT TEST WAS PASSED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 9792071 ↗
  • InjuryMar 5, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY WENT TO EMERGENCY MEDICAL SERVICES DUE TO LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE LEVEL OF 30 AND 31 MG/DL AT THE TIME OF EVENT. CUSTOMER WAS TREATED WITH SUGAR SOLUTION, FOOD AND INTRAVENOUSLY. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR ALARM. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID DISPLACEMENT TEST AND IT WAS PASSED. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 9791945 ↗
  • MalfunctionFeb 27, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PIECE OF THE INSULIN PUMP WHERE RESERVOIR GOES IN HAD CRACKED AND PIECE OF IT WAS MISSING. THE CUSTOMER STATED THAT THE RESERVOIR WAS NOT ABLE TO LOCK INTO 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 9762123 ↗
  • MalfunctionFeb 21, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE UP AND DOWN BUTTONS OF INSULIN PUMP WERE LESS RESPONSIVE AND WERE HARDER TO PRESS. CUSTOMER STATED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALERTS NOT DUE TO SITE ISSUES AND REJECTS 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 9737947 ↗
  • MalfunctionFeb 3, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP¿S BUTTONS WERE STICKY, HARD TO PRESS AND UNRESPONSIVE HOWEVER, INSULIN PUMP WAS REJECTED BRAND NEW BATTERY. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM, SCRATCHES ON SCREEN AND BATTERY LIFE WAS DIMINISHED. 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 9659008 ↗
  • InjuryJan 31, 2020Obstruction of Flow; Obstruction of Flow

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL.

    Patient problems: Hyperglycemia

    MAUDE report 9650766 ↗
  • MalfunctionJan 17, 2020Mechanical Problem; Obstruction of Flow; Priming Problem; Mechanical Problem; Obstruction of Flow; Priming Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND DID NOT PRIME OR ADMINISTER INSULIN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER DECLINED TROUBLESHOOTING WITH TECHNICAL SUPPORT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9599871 ↗
  • MalfunctionJan 15, 2020Mechanical Problem; Obstruction of Flow; Detachment of Device or Device Component; Mechanical Problem; Obstruction of Flow; Detachment of Device or Device Component

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR WHILE DELIVERING A BOLUS AND THE DRIVE SUPPORT CAP WAS FLUSH. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 223 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PUMP HAD NO DELIVERY ALARM. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9594484 ↗
  • MalfunctionJan 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS ON THE INSULIN PUMP STOPPED WORKING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 98 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE TIME WAS ADVANCING. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9552344 ↗
  • MalfunctionDec 12, 2019Device 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER REPORTED THAT BELT CLIP KEPT COMING OFF AND BATTERY WAS CHANGED WITHIN 6 DAYS. CUSTOMER RECEIVED A LOT OF NO DELIVERY ALERTS AND BUTTONS HAD TO BE PRESSED SEVERAL TIMES, INSULIN MOTOR GRINDING SOUNDS WERE TOO LOW. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9456603 ↗
  • InjuryDec 11, 2019Adverse 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 HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE CAUSED BY THE FLU. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER VERIFIED SERIAL NUMBER AND ADVISED WAS STILL WEARING HIS INSULIN PUMP WHILE IN THE HOSPITAL. CUSTOMER STATED HE WAS BETTER NOW AND SHOULD BE GOING HOME TODAY. CUSTOMER DECLINED TRANSFER TO TECH SUPPORT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9450010 ↗
  • MalfunctionDec 6, 2019Device 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 INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED TOP LIP RING WAS BROKE OFF. CUSTOMER STATED RESERVOIR WAS ABLE TO LOCK IN PLACE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9422416 ↗
  • MalfunctionNov 25, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTON OF THE INSULIN PUMP WAS NOT RESPONDING. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE ESCAPE BUTTON OF THE INSULIN PUMP WAS NOT RESPONDING. CUSTOMER DID VERIFY THAT THE TIME CLOCK OF THE INSULIN PUMP WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUED THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9368086 ↗
  • MalfunctionNov 25, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD THREE MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9367674 ↗
  • MalfunctionNov 16, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DAMAGE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY HAD DAMAGE ON THE RESERVOIR LIP RING. THE CUSTOMER REPORTED THAT THE RESERVOIR ABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9332721 ↗
  • MalfunctionNov 1, 2019Premature Discharge of Battery; Premature Discharge of Battery

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS ABLE TO COMPLETE REWIND. ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE CUSTOMER WAS ALSO ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9265030 ↗

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

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Sources and updates

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