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Paradigm® REAL-Time Revel™ MMT-523NAS (UDI 00613994743886)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-523NAS PRDGM INS V2.3 SK EN · Class 3

All models of Paradigm REAL-Time Revel (180)

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

Quick summary

This is a Medtronic MiniMed Paradigm Revel insulin pump, a wearable device that delivers insulin through a small catheter under the skin. Most of its 72 adverse event reports describe the pump showing error messages, being hard to program or calibrate, having trouble running or starting up, and battery or button failures; some mention blood sugar running high or low as a result. There are 19 reports of injury and no deaths. 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
72
Deaths reported
0
Injuries reported
19
Recalls naming it
0

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00613994743886), received between Jun 21, 2017 and May 12, 2020 — classified as 19 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (12 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 Difficult to Program or Calibrate12
  • Device Displays Incorrect Message12
  • Mechanical Problem11
  • Patient Device Interaction Problem10
  • Failure to Cycle7
  • Power Problem6
  • Material Protrusion/Extrusion5
  • Adverse Event Without Identified Device or Use Problem4

Patient problems

  • No Consequences Or Impact To Patient48
  • Hyperglycemia21
  • Hypoglycemia6
  • Death1

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 12, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER BLOOD GLUCOSE AT THE TIME OF INCIDENT UNKNOWN. TROUBLESHOOT WAS NOT PERFORMED. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10045956 ↗
  • MalfunctionMar 18, 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 9846305 ↗
  • InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF UNKNOWN VALUE AT THE TIME OF THE INCIDENT. THE CALLER DID NOT KNOW THE EXACT BLOOD GLUCOSE VALUE BUT STATED IT WAS TOO HIGH TO DO ANYTHING ABOUT IT. THE CALLER DID NOT MENTION HOW THE CUSTOMER TREATED. THE CALLER DID NOT MENTION THE CUSTOMER'S SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER USED THIRD PARTY SENSORS. TROUBLESHOOTING WAS NOT COMPLETED AS THIS WAS A PAST EVENT. THE CALLER REPORTED THE CUSTOMER PASSED ON (B)(6) 2018. THE INSULIN PUMP WILL NOT BE RETURNED AS IT IS NO LONGER IN THE CALLER'S POSSESSION.

    Patient problems: Death; Hyperglycemia

    MAUDE report 9816961 ↗
  • MalfunctionFeb 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP¿S THREADING OF RESERVOIR RING HAD CRACKED AND RESERVOIR WOULD FALL OUT. 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 9674919 ↗
  • MalfunctionJan 20, 2020Failure to Cycle; Failure to Cycle

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING PRIME. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 124 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM AND ALSO WERE ABLE TO REWIND THE INSULIN PUMP. 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 9605529 ↗
  • MalfunctionJan 7, 2020Failure to Cycle; Failure to Cycle

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9556721 ↗
  • MalfunctionDec 24, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY HAD RECEIVED BUTTON ERROR DURING BOLUS. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. 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 9516019 ↗
  • MalfunctionDec 5, 2019Mechanical Problem; Obstruction of Flow; Power Problem; Mechanical Problem; Obstruction of Flow; Power Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP REJECTED NEW BATTERIES AND BATTERY LIFE WAS DIMINISHED TO ONE WEEK. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. IT WAS ALSO REPORTED THAT CUSTOMER HAD TO REWIND INSULIN PUMP MORE THAN ONCE AND ALSO RECEIVED UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9421163 ↗
  • MalfunctionNov 11, 2019Device Difficult to Program or Calibrate; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SEVERAL ISSUES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP BATTERY LIFE DOES NOT LAST LONG, CRACKS ON THE SCREEN AND CASING AND UP BUTTON WAS HARD TO PRESS. CUSTOMER DECLINED TROUBLESHOOTING. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9303544 ↗
  • MalfunctionJul 26, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTS THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER DID NOT REPORT MOTOR POSITION ENCODER ERROR. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. CUSTOMER STATED THE INSULIN EXITED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WAS ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8829600 ↗
  • MalfunctionJul 8, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COSMETIC DAMAGE AND STUCK BUTTON ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. CUSTOMER REPORTED THAT RESERVOIR HAD A CRACK. CUSTOMER REPORTED THAT RESERVOIR WAS ABLE TO LOCK IN PLACE. CUSTOMER WAS ADVISED TO REVERT TO BACKUP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8766940 ↗
  • MalfunctionJun 27, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8738880 ↗
  • MalfunctionJun 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALARMED FOR BUTTON ERROR ALARM AND BUTTON WAS NOT RESPONDING. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT TIME ON INSULIN PUMP CHANGED WHEN WAITED FOR ONE MINUTE TO VERIFY IF TIME ADVANCES. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. INSULIN PUMP WILL BE RETURN FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8715316 ↗
  • MalfunctionJun 4, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Material Integrity Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WAS HARD TO PRESS AND STICKY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8665734 ↗
  • MalfunctionJun 3, 2019Device Alarm System; Failure to Cycle; Detachment of Device or Device Component; Device Alarm System; Failure to Cycle; Detachment of Device or Device Component

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. CUSTOMER STATED HIS INSULIN PUMP WAS ALSO MAKING MORE NOISE THAN USUAL WHEN TRYING TO PUSH OUT INSULIN. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8662305 ↗
  • MalfunctionMay 31, 2019Failure to Cycle; Detachment of Device or Device Component; Patient Device Interaction Problem; Failure to Cycle; Detachment of Device or Device Component; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 106 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT AND BATTERY COMPARTMENT WAS CRACKED. 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 8657232 ↗
  • MalfunctionMay 8, 2019Device Alarm System; Device Difficult to Program or Calibrate; Device Alarm System; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE ACT BUTTON WAS NOT RESPONDING. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. 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 8589739 ↗
  • MalfunctionMay 3, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTON HARDER TO PUSH. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES INSULIN PUMP SEEMS LIKE HAZY ON SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8576834 ↗
  • MalfunctionApr 27, 2019Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP¿S SCREEN WAS SCRATCHED AND HARDER TO READ. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE INSULIN PUMP¿S SCREEN WAS UNABLE TO READ DUE TO SCRATCHES. THE CUSTOMER STATED THAT THE INSULIN PUMP REJECTED THE NEW BATTERY AND INSULIN PUMP¿S BUTTONS ARE HARDER TO PRESS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8558849 ↗
  • MalfunctionApr 26, 2019Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR AND PARTIAL DISPLAY ON SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM. THE CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND AND PARTIAL DISPLAY ON SCREEN. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8554277 ↗
  • MalfunctionApr 24, 2019Premature Discharge of Battery; No Display/Image; Premature Discharge of Battery; No Display/Image

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND CUSTOMER REPORTS DISPLAY WAS BLANK CURRENTLY. CUSTOMER STATES 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 STATES THE CONTACT ON THE BATTERY CAP WAS NEITHER MISSING NOR DAMAGE. CUSTOMER STATES BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WILL BE REPLACED AS PER TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8543786 ↗
  • MalfunctionApr 18, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

    THE CUSTOMER'S HUSBAND WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ESC AND ACT BUTTONS WERE HARD TO PRESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE BUTTONS OF THE INSULIN PUMP WERE NOT RESPONDING. 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 8526698 ↗
  • MalfunctionApr 11, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8502939 ↗
  • MalfunctionMar 27, 2019Mechanical Problem; Mechanical Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. MOTOR ERROR OCCURRED MULTIPLE TIMES OVER PAST FEW MONTHS. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8454767 ↗
  • InjuryMar 26, 2019Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8454248 ↗

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-1750-2026 · Feb 13, 2026 · Open, Classified
    Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
  • Z-1749-2026 · Feb 13, 2026 · Open, Classified
    Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
  • 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-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-1591-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
  • 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-1587-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
  • 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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