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Paradigm® REAL-Time Revel™ MMT-723LNAP (UDI 00643169478596)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-723LNAP PRDGM V2.5B PL LN IPX7 · 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. The 46 reports mostly describe the pump stopping or failing to deliver insulin, showing error messages or unexpected alarms, buttons that stick or stop responding, cracked housings and battery compartments, and water damage. Reports also mention high blood sugar (16 cases) and low blood sugar (3). There were 16 injuries 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
46
Deaths reported
0
Injuries reported
16
Recalls naming it
0

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00643169478596), received between Jun 2, 2017 and Nov 3, 2020 — classified as 16 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (15 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 Message15
  • Adverse Event Without Identified Device or Use Problem7
  • Patient Device Interaction Problem7
  • Battery Problem4
  • Device Difficult to Program or Calibrate4
  • Device Alarm System3
  • Material Integrity Problem3
  • Mechanical Problem3

Patient problems

  • No Consequences Or Impact To Patient26
  • Hyperglycemia16
  • Hypoglycemia3
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 3, 2020Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM, REJECT NEW BATTERIES, CHIPPING NEAR RESERVOIR AREA, SETTING DID NOT CAME BACK. 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 10776560 ↗
  • MalfunctionJan 31, 2020Premature Discharge of Battery; Patient Device Interaction Problem; Premature Discharge of Battery; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT THE TEMP BASAL WAS NOT PROGRAMMED BEFORE THE ALARM OCCURRED. THE CUSTOMER REPORTED THAT THE ALARM WAS OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER STATED THAT THE INSULIN PUMP HAD CRACK ON BATTER COMPARTMENT AND THEY NOTICED IT WHILE UNSCREWING THE BATTERY CAP. CUSTOMER STATED THAT THE RESERVOIR LIP RING WAS NOT DAMAGED. 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 9651266 ↗
  • MalfunctionOct 1, 2019No Display/Image; Mechanical Problem; Patient Device Interaction Problem; No Display/Image; Mechanical Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED MOTOR ERROR AND INSULIN PUMP STOP WORKING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP BATTERY COMPARTMENT WAS BROKEN AND UNSCREWS ON ITS OWN. 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 AS PER HEALTH CARE PROFESSIONAL INSTRUCTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9140220 ↗
  • MalfunctionSep 12, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ACT BUTTON WERE STUCK. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT BUTTONS NEE TO PRESS REPEATEDLY TO RESPOND. 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 9003663 ↗
  • MalfunctionSep 11, 2019Device Alarm System; No Display/Image; Material Integrity Problem; Moisture or Humidity Problem; Power Problem; No Apparent Adverse Event; Device Alarm System; No Display/Image; Material Integrity Problem; Moisture or Humidity Problem; Power Problem; No Apparent Adverse Event

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS NOT WORKING AFTER WATER DAMAGE AS WELL AS CONSTANTLY ALARMING BEFORE SHUTTING DOWN. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP DISPLAY WENT BLANK IMMEDIATELY AFTER PUMP EXPOSURE TO MOISTURE AND CAP WAS WORN OR DAMAGED. CUSTOMER STATED THAT INSULIN PUMP FELL INTO THE ICE CHEST WAS IN AN ICE PACK AND FELL INTO THE ICE CHEST WAS IN AN ICE PACK AND INSULIN PUMP WAS VIBRATING WITHOUT AN ALARM OR ALERT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8987708 ↗
  • MalfunctionJun 4, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HA MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 385 MG/DL. CUSTOMER ALSO STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. 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 BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8665519 ↗
  • MalfunctionMay 13, 2019Device Alarm System; Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem; Patient Device Interaction Problem; Device Alarm System; Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem; Patient Device Interaction Problem

    CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS DIFFICULT TO OPERATE AS WELL AS INSULIN PUMP WAS NOT ALARMING THAT SHE WAS OUT OF INSULIN. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE BUTTONS DID NOT RESPOND, CRACKED AT THE TOP OF THE INSULIN PUMP AND RESERVOIR AREA LOOKS WORN ALMOST LIKE A RUST BUT NOT RUST AS WELL AS DISCOLORATION ON THE METAL WAS CHANGED. CUSTOMER STATED THAT THE COVER ON THE BATTERY AREA DOES NOT LINE UP ANYMORE. TROUBLESHOOTING WAS NOT PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8602628 ↗
  • MalfunctionApr 25, 2019Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR MOTOR POSITION ENCODER ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. DRIVE SUPPORT CAP APPEARS TO BE NORMAL. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8548584 ↗
  • MalfunctionApr 2, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ISSUES WITH THE BUTTONS AND GETTING THE UNEXPECTED RESTART. A COLD RESET WAS PERFORMED ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER STATE THAT INSULIN PUMP HAD LOST ALL SETTINGS AND TWICE REJECTED NEW BATTERIES AND ALSO REPORT THE CRACK AT THE UPPER RIGHT CORNER OF DISPLAY ON CASING AND GOES TO THE BACK OF THE INSULIN PUMP. 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 8472180 ↗
  • MalfunctionJan 16, 2019Insufficient Flow or Under Infusion; Connection Problem; Patient Device Interaction Problem; Insufficient Flow or Under Infusion; Connection Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DID NOT DELIVERED THE INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 132 MG/DL. CUSTOMER ALSO REPORTED THAT THE INFUSION SET AND RESERVOIR WAS POPPED OFF AND THE PART WHERE IT WAS LOCKING THERE WAS DAMAGED AND IT WAS NOT LOCKING IN PLACE. 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 8255130 ↗
  • InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    THE PHYSICIAN REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 300 MG/DL AT TIME OF INCIDENT. THE CUSTOMER'S CURRENT BLOOD GLUCOSE IS 458 MG/DL. THE CUSTOMER DID EXPERIENCED THE SYMPTOMS SUCH AS VOMITING. THE CUSTOMER WAS TREATED BY BOLUS WITH FLUID INSULIN DRIP. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8195414 ↗
  • InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CUSTOMER'S NURSE REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT TIME OF INCIDENT. CUSTOMER TREATED WITH MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE LEVEL. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8093572 ↗
  • MalfunctionNov 8, 2018Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY AND UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 153 MG/DL. THE CUSTOMER REPORTED THAT THEY HAD UNEXPECTED RESTART ALARM. IT WAS REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE AND ALSO HAD BUTTON ERROR. 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 HEALTHCARE 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 8050439 ↗
  • InjuryNov 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER BLOOD GLUCOSE LEVEL 531 MG/DL. CUSTOMER ALSO STATED THAT THE THEY NEED ASSISTANCE TO REWIND THE INSULIN PUMP. ASSISTANCE WAS PROVIDED AND REWIND WAS SUCCESSFUL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8036076 ↗
  • MalfunctionOct 24, 2018Failure to Cycle; Failure to Cycle

    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. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7998587 ↗
  • MalfunctionOct 23, 2018Detachment of Device or Device Component; 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 215 MG/DL. THE CUSTOMER ALSO EXPERIENCED OTHER BLOOD GLUCOSE LEVEL "WAS": 60 MG/DL, 340 MG/DL, 60 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. 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 INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7994388 ↗
  • MalfunctionOct 16, 2018Material Integrity Problem; Material Integrity Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN SQUIRTING OUT FROM CANNULA, ERROR CODE DISPLAY ON THE INSULIN PUMP AND THEN INSULIN PUMP SHUT DOWN. 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 7972088 ↗
  • InjuryOct 2, 2018Adverse 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 473 MG/DL. THE CUSTOMER WAS TREATED WITH BOLUS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 7927082 ↗
  • MalfunctionSep 18, 2018No Apparent Adverse Event; No Apparent Adverse Event

    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 INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 7887138 ↗
  • MalfunctionAug 21, 2018Adverse 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 OF 600MG/DL WHICH WAS TREATED WITH MANUAL INJECTIONS AND WENT TO EMERGENCY ROOM. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 62MG/DL. CUSTOMER PERFORMED HIGH PRESSURE TEST AND PASSED THE TEST. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 7800513 ↗
  • MalfunctionAug 10, 2018Power Problem; Power Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DID NOT ALARM LOW BATTERY PRIOR TO OFF NO POWER ALERT. THE CUSTOMER'S BLOOD GLUCOSE WAS 109 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVISED TO INSERT A NEW BATTERY AND MONITOR THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7771186 ↗
  • InjuryJun 18, 2018Bent

    CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE AND GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 54 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 65 TO 90 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS GIVEN FOOD TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS SPIT ON THEIR CHEST. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS COMPLETED AND IT WAS DISCOVERED THE PUMP TIME WAS INCORRECT. THE CUSTOMER HAD A BENT SET CANNULA ISSUE, AND HAD THE PUMP EXPOSED TO CANCER RADIATION TREATMENT MACHINES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 7609931 ↗
  • MalfunctionJun 18, 2018Device Displays Incorrect Message

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALERTS AND HAS TO REWIND PROCESS OVER TO MAKE THE INSULIN PUMP WORK AGAIN. CUSTOMER ALSO REPORTED THAT INSULIN PUMP WAS LOUDER DURING REWIND. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7608739 ↗
  • InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 600 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 7599703 ↗
  • MalfunctionJun 6, 2018Device Displays Incorrect Message; Malposition of Device

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 196 MG/DL AT THE TIME OF THE INCIDENT THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS RECESSED. 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 7572917 ↗

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-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-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-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-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-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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