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Paradigm® REAL-Time Revel™ MMT-523RNAS (UDI 00643169221550)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-523RNAS PRDGM V2.5B SK EN RH X7 · 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 is an insulin pump system. The 309 reports mostly describe high blood sugar readings, buttons that stop responding, alarms and wrong messages on the screen, and some cracked or broken reservoir parts. There are 2 deaths and 144 injuries reported, and 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
309
Deaths reported
2
Injuries reported
144
Recalls naming it
0

Summary

The FDA's MAUDE database contains 309 adverse event reports that list this exact device (DI 00643169221550), received between Jun 2, 2017 and Jul 16, 2020 — classified as 2 deaths, 144 injuries, 163 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (39 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

  • Adverse Event Without Identified Device or Use Problem51
  • Patient Device Interaction Problem39
  • Device Displays Incorrect Message38
  • No Apparent Adverse Event27
  • Device Difficult to Program or Calibrate22
  • Insufficient Device Problem Information21
  • Mechanical Problem19
  • Break15

Patient problems

  • No Consequences Or Impact To Patient144
  • Hyperglycemia134
  • Hypoglycemia42
  • Death4
  • Elevated Ketones/ Diabetic Ketoacidosis3
  • No Known Impact Or Consequence To Patient2
  • Blood Loss1
  • Dehydration1

Recent adverse event reports

The 25 most recent of 309 reports, in the reporter's own words as published by the FDA.

  • DeathJul 16, 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 PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS STILL UNKNOWN. THE CALLER STATED THAT THEY DID NOT KNOW IF THE CUSTOMER HAD ANY OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 400 MG/DL BEFORE THEY TREATED AND WENT TO BED. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER STATED THE CUSTOMER WAS HAVING HIGH BLOOD GLUCOSE OF 200 TO 400 MG/DL BEFORE GOING TO BED, BOLUSED, AND THEN WENT TO SLEEP. THE CALLER STATED THEY DON'T KNOW WHAT HAPPENED BUT THEY BELIEVE THE PUMP DID NOT CAUSE THE CUSTOMER'S PASSING. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Patient problems: Death; Hyperglycemia

    MAUDE report 10281825 ↗
  • MalfunctionJun 15, 2020Device Difficult to Program or Calibrate; 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 AN ERROR HE CANNOT CLEAR FROM THE PUMP. THE CUSTOMER STATED WAS ABLE TO CLEAR THE ALARM, BUT NO BUTTONS WORKED. 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 10151945 ↗
  • MalfunctionMay 15, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS DAMAGED NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL WAS RETURN FOR ANALYSIS AND FOUND THE PUMP RECEIVED WITH RESERVOIR TUBE LIP COMPLETELY BROKEN OFF NOTED. THE TEST RESERVOIR DOES NOT STAY LOCKED IN PLACE DUE TO RESERVOIR TUBE LIP BROKEN OFF. UNABLE TO PERFORM DISPLACEMENT TEST DUE TO RESERVOIR LIP BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10060210 ↗
  • MalfunctionApr 8, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER STATED THAT THE TIME CLOCK WAS ADVANCING. 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 9936916 ↗
  • MalfunctionMar 13, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCREEN LETTERING HAD FADED AND MAKING IT DIFFICULT TO READ, BACK AND ACT BUTTONS WERE SOMETIMES NON RESPONSIVE. THE CUSTOMER ALSO REPORTED THAT BATTERY DID NOT LAST LONGER THAN A WEEK AND ALSO RECEIVED BAD BATTERY ALERT. 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 9828262 ↗
  • MalfunctionFeb 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE TOP CHAMBER OF RESERVOIR WAS CAME OFF ALSO THE RUBBER RING WAS GONE. CUSTOMER STATED THAT THE RESERVOIR DID LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER STATED THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER STATED THE INFUSION SET AND RESERVOIR DID NOT SHOW SIGNS OF DAMAGE. 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 9693147 ↗
  • MalfunctionFeb 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK AT SCREEN AND LIP RING WAS BROKEN. THE CUSTOMER STATED THAT THE RESERVOIR DOES 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 9679655 ↗
  • InjuryJan 7, 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¿S DAUGHTER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019, WITH BLOOD GLUCOSE OF OVER 900 MG/DL. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WAS NOT WORKING. CUSTOMER WAS UNCONSCIOUS. THE CUSTOMER WAS TREATED WITH INSULIN DRIP FOR 48 HOURS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9556741 ↗
  • InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 250 MG/DL AT THE TIME OF INCIDENT AND THE OTHER BLOOD GLUCOSE LEVEL WAS 277 MG/DL AND 411 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH SHOTS AND INSULIN. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER DID NOT MENTION ANY SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NOT ALLEGING INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. CUSTOMER REPORTED THAT THEY HAVE CONTACTED THEIR HEALTHCARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT THEY WERE NOT ADMITTED TO EMERGENCY ROOM, NOR HOSPITAL OR NOR TO EMERGENCY MEDICAL SERVICE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9351530 ↗
  • MalfunctionNov 16, 2019Premature Discharge of Battery; Premature Discharge of Battery

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD AN UNEXPECTED RESTART. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 132 MG/DL. CUSTOMER ABLE TO COMPLETE REWIND. CUSTOMER REPORTED THAT ERROR REOCCURRED AGAIN AFTER BATTERY CHANGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9332824 ↗
  • MalfunctionNov 8, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    CUSTOMER REPORTED VIA PHONE CALL THAT THE PUMP WAS NOT GIVING INSULIN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 227 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9294252 ↗
  • MalfunctionNov 6, 2019Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE DISPLAY SCREEN OF INSULIN PUMP WAS SCRATCHED PRETTY BAD AND MAKES IT DIFFICULT TO READ SOMETIMES. THE CUSTOMER¿S BLOOD GLUCOSE UNKNOWN. CUSTOMER STATED THAT THEY HAD TO PRIME INSULIN PUMP MORE THAN ONCE ALSO RECEIVED RANDOM UNEXPLAINED NO DELIVERY ALARMS. CUSTOMER ALSO STATED THAT THEY HAD REPLACE BATTERIES EVERY 7 DAYS IN EVERY WEEK. THE DEVICE WILL NOT RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9283186 ↗
  • InjuryOct 31, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE OF 40 MG/DL. CUSTOMER STATED THAT INSULIN PUMP HAD CRACK AT CURVE PART OF THE ESCAPE DIAGONAL OVER TO THE VIEWING GLASS AS CUSTOMER DROPPED THE INSULIN PUMP. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 9261229 ↗
  • MalfunctionOct 18, 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 KEYPAD BUTTONS WERE HARDER TO PRESS FOR THE RESPONSE. 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 9206404 ↗
  • MalfunctionOct 14, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ACT BUTTON OF THE INSULIN PUMP WAS STICKING. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT INSULIN PUMP HAD MOTOR ERROR AND FAILURE ALARMS. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9184194 ↗
  • InjurySep 12, 2019Failure to Cycle; Appropriate Device Problem Term/Code Not Available; Failure to Cycle; Appropriate Device Problem Term/Code Not Available

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE AND INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 35 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 9017421 ↗
  • InjuryAug 30, 2019Adverse 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. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 430 MG/DL. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN BOLUS. BASED ON CUSTOMER¿S REPORT CUSTOMER DID NOT ALLEGE UNDER DELIVERY. CUSTOMER USING INSULIN PUMP WITHIN 48 HOURS OF HIGH BLOOD GLUCOSE OF EVENT. THE CUSTOMER WAS REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8948652 ↗
  • MalfunctionAug 22, 2019Device Alarm System; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Device Alarm System; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS ON INSULIN PUMP WERE LESS RESPONSIVE AND HARDER TO PRESS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP HAD NO DELIVERY ALERTS, INSULIN PUMP WAS NOT ALERTING WHEN BATTERY WAS LOW AND RESERVOIR COMPARTMENT WAS STRIPPED. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8919584 ↗
  • MalfunctionAug 22, 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. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT THE BUTTONS WERE NOT RESPONDING. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WOULD NEED TO BE REPLACED AND REVERT TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8919483 ↗
  • MalfunctionAug 22, 2019Computer Software Problem; Computer Software Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED FAILURE OF FLASH MEMORY ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 150 MG/DL. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE NOT ABLE TO REWIND THE PUMP. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8919384 ↗
  • MalfunctionAug 13, 2019No Display/Image; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; No Display/Image; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE BUTTONS ON THE INSULIN PUMP WERE STICKING. CUSTOMER STATED THAT THE SCREEN WENT BLANK AND DID NOT COME BACK ON. CUSTOMER DECLINED TROUBLESHOOT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8886913 ↗
  • MalfunctionAug 5, 2019Premature Discharge of Battery; Patient Device Interaction Problem; Premature Discharge of Battery; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 131 MG/DL. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATES INSULIN PUMP ALARMED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER ALSO REPORTED THAT INSULIN PUMP CHIPPED OF FROM THE TOP. CUSTOMER 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 8858575 ↗
  • InjuryJul 29, 2019Adverse 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 LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS OVER 600 MG/DL AT THE TIME OF INCIDENT. CUSTOMER TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER ALSO STATED THAT INFUSION SET HAD BENT CANNULA. CUSTOMER STATED THAT SERTER WAS LITTLE SLIGHTLY LIFTED BEFORE LOCKED IN PLACE AND LOOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8836997 ↗
  • MalfunctionJul 22, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE LESS RESPONSIVE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT SOMETIMES HAD TO PRESS BUTTONS TWICE. THE CUSTOMER ALSO REPORTED THAT THEY REPLACED BATTERY AND THE INSULIN PUMP LOST SETTINGS AND HAD UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8810590 ↗
  • MalfunctionJul 22, 2019Power Problem; No Apparent Adverse Event; Power Problem; No Apparent Adverse Event

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP STOPPED WORKING. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. CUSTOMER ALSO REPORTED BATTERY OUT LIMIT ALARM AND SHE WAS NOT ABLE TO CLEAR THE ALARM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8810377 ↗

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-1593-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
  • 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-1590-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
  • Z-1591-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
  • Z-1589-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
  • Z-1588-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
  • 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

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Sources and updates

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