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Paradigm® REAL-Time Revel™ MMT-723RNAS (UDI 00613994904386)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-723RNAS PRDGM INS V2.4 SK EN RC · 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 MiniMed Paradigm REAL-Time Revel insulin pump has 109 adverse event reports, with 6 deaths and 39 injuries. Reports most often describe wrong messages on the screen, unexpected restarts and alarms, and power problems, and many mention high blood sugar. 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
109
Deaths reported
6
Injuries reported
39
Recalls naming it
0

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 00613994904386), received between Jun 2, 2017 and Aug 5, 2020 — classified as 6 deaths, 39 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (20 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 Message20
  • Adverse Event Without Identified Device or Use Problem14
  • Device Difficult to Program or Calibrate9
  • Device Operates Differently Than Expected9
  • Insufficient Device Problem Information8
  • No Display/Image7
  • Power Problem7
  • Device Alarm System6

Patient problems

  • No Consequences Or Impact To Patient54
  • Hyperglycemia44
  • Hypoglycemia8
  • Death7
  • No Known Impact Or Consequence To Patient2
  • Elevated Ketones/ Diabetic Ketoacidosis1
  • Loss of consciousness1

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP'S DRIVE SUPPORT CAP WAS PROTRUDED. CUSTOMER STATED THAT INSULIN WAS SQUIRTING OUT DURING MANUAL PROCESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10366240 ↗
  • MalfunctionJul 19, 2020Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. TIME CLOCK WAS NOT 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 10293767 ↗
  • MalfunctionJul 8, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACTIVATION BUTTON OF THE INSULIN PUMP WAS NOT WORKING BUT ALL OTHER BUTTONS WERE 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 10244689 ↗
  • InjuryJun 8, 2020Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 589 MG/DL AT THE TIME OF THE INCIDENT AND OTHER BLOOD GLUCOSE VALUE WAS 592 MG/DL, 570 MG/DL AND 560 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED ERROR. CUSTOMER ABLE TO COMPLETE REWIND. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 10126920 ↗
  • MalfunctionMay 19, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCREEN ON THE INSULIN PUMP FADES OUT AND CANNOT SEE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10069400 ↗
  • MalfunctionApr 15, 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 WHEN CUSTOMER PUT THE BATTERY IN THE SCREEN CAME UP WITH AUTO OFF AND INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER REPORTED THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER ALSO REPORTED THAT DISPLAY WAS FROZEN AND KEYPAD WAS UNRESPONSIVE. 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 9965045 ↗
  • InjuryFeb 12, 2020Power Problem; Power Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 477 MG/DL. THE CUSTOMER STATED THAT INSULIN PUMP WAS NOT WORKING AND THERE WAS NO INSULIN ON THE INSULIN PUMP, HAD NO RESERVOIR TO THE INSULIN PUMP. THE INSULIN PUMP ALARMED BATTERY OUT LIMIT. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9698910 ↗
  • MalfunctionJan 28, 2020Device Alarm System; Power Problem; Device Alarm System; Power Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SHUTTING OFF AND ALARMS HAD DIMINISHED IN SOUND. 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 9635948 ↗
  • MalfunctionJan 22, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER STATED THAT THEY WERE ABLE TO COMPLETE REWIND. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR ALARM. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP HAD MULTIPLE UNEXPECTED RESTART ALARM AFTER MULTIPLE BATTERY CHANGE. 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 9615349 ↗
  • MalfunctionDec 13, 2019Obstruction of Flow; Obstruction of Flow

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD INSULIN FLOW BLOCKED ALARM AND THAT THEY HAD TRIED ALL REMEDIES. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 294 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THE TUBING WAS NOT BENT OR KINKED. CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9465730 ↗
  • MalfunctionNov 26, 2019Device Alarm System; Premature Discharge of Battery; Mechanical Problem; Device Alarm System; Premature Discharge of Battery; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SQUIRTS WHEN PRIMING AND ALARM NOT AS LOUD. THE BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT REWIND WAS LOUDER. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9375154 ↗
  • InjuryOct 23, 2019Obstruction 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. CUSTOMER¿S BLOOD GLUCOSE WAS IN THE RANGE OF 300 MG/DL TO 500 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED OTHER BLOOD GLUCOSE VALUES SUCH AS 532 MG/DL, 515 MG/DL, 473 MG/DL, 300 MG/DL. CUSTOMER USING INSULIN PUMP WITHIN 48 HOURS OF HIGH BLOOD GLUCOSE OF EVENT. INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR NO DELIVERY ALARM. THE CUSTOMER WAS STATED THAT THE INSULIN WAS EXITED. ISSUE WAS RESOLVED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9229149 ↗
  • InjuryOct 12, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE EXPERIENCED HYPERGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 486 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP HAD A MOTOR ERROR AND INSULIN PUMP WAS NOT CONNECTED TO HER BECAUSE OF THE MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. THE CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWOUND. THE CUSTOMER 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: Hyperglycemia

    MAUDE report 9183459 ↗
  • InjurySep 18, 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 THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 550 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS DECLINED TO TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE CUSTOMER NEEDLE ON SURE T GETS IN SCAR TISSUE INSULIN DID NOT DISTRIBUTE. CUSTOMER STATED THAT THE ISSUE WITH RESERVOIR AND NOT FOR INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9080767 ↗
  • MalfunctionSep 6, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR CASING WAS CRACKED IN MULTIPLE SPOTS AND PIECES WAS MISSING. 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 8968889 ↗
  • MalfunctionAug 21, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A PARTIAL DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE BLANK SCREEN ON THE INSULIN PUMP. CUSTOMER STATED THE BLACK SCREEN DID NOT DISAPPEAR. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8914722 ↗
  • InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    NURSE REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 416 MG/DL AND 344 MG/DL. CUSTOMER TREATED WITH INSULIN PUMP. THE CUSTOMER SAID ITS SHOWING UNDER BOLUS HISTORY HE HAD 10.6 BOLUS FOR HIS BG 344 AND 60 CARBS BUT HE WAS NOT CONNECTED TO THE PUMP THAT TIME AND THE INSULIN JUST CAME OUT ALL THE WAY FROM THE TUBING AND NOW HE WANTED TO GIVE HIMSELF A BOLUS AND HE IS NOW CONNECTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8825716 ↗
  • MalfunctionJul 3, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS WAS NOT WORKING AND ALSO RECEIVED BATTERY OUT LIMIT ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATES THE INSULIN PUMP ALARMED AFTER BATTERY CHANGE. CUSTOMER REPORTED THAT THEY WERE UNABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WILL 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 8757003 ↗
  • InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER¿S FAMILY REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 566 MG/DL. THE CUSTOMER DID NOT EXPERIENCED SYMPTOMS DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE PUMP WAS UNDER DELIVERING. AUTO MODE FEATURE WAS NOT ACTIVE AND AUTOMATICALLY ADJUSTING INSULIN AT TIME OF HIGH BLOOD GLUCOSE EVENT. DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. DISPLACEMENT TEST AND HIGH PRESSURE TEST WAS PASS. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8747073 ↗
  • MalfunctionMay 15, 2019Premature Discharge of Battery; Premature Discharge of Battery

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP RECEIVED UNEXPECTED RESTART ALERT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 137 MG/DL. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING FOR THE UNEXPECTED RESTART ALARM. IT WAS REPORTED THAT THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AS WELL AS COMPLETE THE INSULIN PUMP REWIND. THE CUSTOMER REPORTED THAT THE UNEXPECTED RESTART ALERT RECURRED DURING NORMAL INSULIN PUMP USE. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8610968 ↗
  • MalfunctionMay 1, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Communication or Transmission Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Communication or Transmission Problem; Power Problem; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD UNRESPONSIVE AND THE AUDIO ANOMALY. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS NOT ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE BUTTONS WERE HARD TO PUSH, STICKY OR SOMETIMES UNRESPONSIVE. CUSTOMER ALSO STATED THAT THE NOISE CAN'T HEAR. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8568207 ↗
  • MalfunctionApr 22, 2019Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERRORS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED CHIP ON THE FRAME OF SCREEN AND RANDOM NO DELIVERY ALARMS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8534492 ↗
  • MalfunctionApr 2, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS NOT DELIVERING THE INSULIN AS FAST AS BEFORE BECAUSE HAS HIGHER BLOOD GLUCOSE THAN NORMAL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 222 MG/DL. CUSTOMER VERIFIED THAT BASAL SETTINGS WERE CORRECT. CUSTOMER WAS USING INSULIN PUMP AFTER 2 WEEKS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8472282 ↗
  • InjuryMar 29, 2019Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

    THE CUSTOMER¿S FATHER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS 400 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS REPORTED OTHER BLOOD GLUCOSE VALUE SUCH AS 200 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION FOR HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER WAS DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER WAS ALSO REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER REPORTED THAT THE EVENT WAS RESOLVED BY CHANGING COMPLETE SET. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8464092 ↗
  • MalfunctionMar 13, 2019Device Difficult to Program or Calibrate; 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 NONE OF THE BUTTONS WORK. 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 8416305 ↗

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-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-1594-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
  • Z-1587-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
  • Z-1588-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
  • Z-1592-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
  • 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

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Sources and updates

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