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Paradigm® REAL-Time Revel™ MMT-723LNAL (UDI 00643169478589)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-723LNAL PRDGM V2.5B CL 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 Medtronic MiniMed Paradigm Revel insulin pump is worn to deliver insulin. Many of the 80 reports describe incorrect display messages, mechanical problems and motor errors, and some describe a blank display. The reports include 1 death and 22 injuries. 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
80
Deaths reported
1
Injuries reported
22
Recalls naming it
0

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00643169478589), received between Jun 8, 2017 and May 28, 2024 — classified as 1 death, 22 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (19 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Displays Incorrect Message19
  • Mechanical Problem14
  • No Display/Image11
  • Device Difficult to Program or Calibrate10
  • Patient Device Interaction Problem10
  • Failure to Cycle8
  • Adverse Event Without Identified Device or Use Problem7
  • Obstruction of Flow6

Patient problems

  • No Consequences Or Impact To Patient53
  • Hyperglycemia21
  • Hypoglycemia5
  • No Clinical Signs, Symptoms or Conditions2
  • Death1

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 28, 2024Mechanical Problem; Mechanical Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED A MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER WAS ABOUT TO CHANGE THE INFUSION SET. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER DID NOT RECEIVE THE E70 ALARM AND THE PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC ENVIRONMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. HOWEVER, THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WAS BEEN RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19402683 ↗
  • MalfunctionApr 7, 2022Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. CUSTOMER ALSO REPORTED NO DELIVERY. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14043027 ↗
  • MalfunctionJul 23, 2020Mechanical Problem; Mechanical Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR POSITION ENCODER ERROR. 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 10312695 ↗
  • MalfunctionJul 20, 2020Premature Discharge of Battery; Computer Software Problem; Mechanical Problem; Loss of Data; Premature Discharge of Battery; Computer Software Problem; Mechanical Problem; Loss of Data

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. INSULIN PUMP ALSO HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARMS AND ABLE TO REWIND THE INSULIN PUMP. DRIVE SUPPORT CAP WAS NORMAL. UNEXPECTED RESTART ALARM WAS RECURRING DURING NORMAL INSULIN PUMP USE. 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 10294656 ↗
  • MalfunctionJul 13, 2020No Display/Image; No Display/Image

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. CUSTOMER STATED THAT THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. CUSTOMER STATED THAT THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED. CUSTOMER STATED THAT THE BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED ALSO THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE DISPLAY DID NOT RETURN AFTER INSULIN PUMP RESTART. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10263267 ↗
  • MalfunctionApr 6, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTON ON THE INSULIN PUMP WERE UNRESPONSIVE. CUSTOMER STATED THAT THE INSULIN PUMP INSULIN PUMP WAS SLOWER DURING 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 9931059 ↗
  • MalfunctionMar 11, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND NO DELIVERY ALARM. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT EVENT WERE RESOLVED BY CHANGING RESERVOIR. CUSTOMER STATES PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO REWIND THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9816681 ↗
  • MalfunctionFeb 26, 2020Mechanical Problem; Detachment of Device or Device Component; Patient Device Interaction Problem; Mechanical Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR, DRIVE SUPPORT CAP WAS STICKING OUT AND THE INSULIN PUMP WAS TOTALLY NOT WORKING. THE INSULIN PUMP WAS BUMPED. 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 9754669 ↗
  • MalfunctionJan 24, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED DURING SEATING THE FORCE SENSOR DID NOT DETECT THE RESERVOIR. THE DEVICE WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM AND THE DRIVE SUPPORT CAP APPEARED FLUSH. 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 9625795 ↗
  • InjuryJan 6, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED THE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 499 MG/DL, 399 MG/DL AND 405 MG/DL. THE CUSTOMER WAS ALLEGES THAT THE INSULIN PUMP WAS UNDER DELIVERING BECAUSE OF HER HIGH BLOOD GLUCOSE. THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, AS A RESULT OF HIGH BLOOD GLUCOSE. THE CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9550272 ↗
  • MalfunctionDec 5, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

    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 BUTTONS WERE LESS RESPONSIVE AND WERE HARDER TO PRESS SOMETIMES HAD TO PRESS BUTTONS TWICE. CUSTOMER STATED THAT BATTERY COMPARTMENT HAD PIECE BROKEN AND FLAKING OFF HEN CHANGING BATTERY EVERY 2 WEEKS. CUSTOMER STATED THAT AND SLOWER DURING REWIND AND LOUDER DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9414699 ↗
  • MalfunctionDec 2, 2019Display or Visual Feedback Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DEEP SCRATCHES ON SCREEN WHICH MAKE IT HARD TO READ, ALARMS COME ON ONLY AT 20 UNIT THEN IT DID ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARM, BACK LIGHT WAS DIMMER, BATTERY LAST 7 DAYS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9399574 ↗
  • MalfunctionOct 29, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD STICKY BUTTONS AND MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP HAD LOSE BATTERY CAP. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9249496 ↗
  • MalfunctionOct 18, 2019Premature Discharge of Battery; No Display/Image; Power Problem; Premature Discharge of Battery; No Display/Image; Power Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 241 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED UNEXPECTED RESTART ALARM WAS REOCCURRED AFTER BATTERY CHANGE. CUSTOMER STATED INSULIN PUMP HAD BLANK DISPLAY AND DISPLAY RETURNED. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9207488 ↗
  • MalfunctionSep 25, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS OF INSULIN PUMP WERE NOT WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9114649 ↗
  • MalfunctionSep 12, 2019Failure 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 372 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM(S). CUSTOMER REPORTS PUMP DID REQUIRE REWIND. CUSTOMER ABLE TO COMPLETE REWIND. 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 9000935 ↗
  • MalfunctionAug 23, 2019Failure to Cycle; Failure to Cycle

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 119 MG/DL. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8925022 ↗
  • MalfunctionAug 22, 2019Failure 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 262 MG/DL AT THE TIME OF THE INCIDENT. 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 BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8920564 ↗
  • MalfunctionAug 12, 2019Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Power Problem; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DID NOT WORK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 203 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED BECAUSE THEY FORGOT TO TAKE OFF THE INSULIN PUMP AND GOT INTO THE POOL FOR 30 MINUTES AND NOW DID NOT WORK. CUSTOMER STATED THAT THE WHOLE LIQUID CRYSTAL DISPLAY SCREEN WAS BLACKED OUT AND THERE WAS WATER UNDER SCREEN IT DID START UP EVERY NOW AND THEN BUT STOPS AND NONE OF THE BUTTONS FUNCTION AT ALL THERE WAS WATER INSIDE THE INSULIN PUMP AT THE MOTOR, PRIOR TO GETTING THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8882066 ↗
  • MalfunctionJun 26, 2019Device Alarm System; No Display/Image; Patient Device Interaction Problem; Device Alarm System; No Display/Image; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DISPLAY WAS BLANK AND HAD BEEP ANOMALY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD CONSTANT TONE AND DISPLAY WAS BLANK. 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 8734093 ↗
  • MalfunctionJun 19, 2019Mechanical Problem; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Mechanical Problem; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD UNSPECIFIED ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD STARTED TO RANDOMLY TURN OFF. THE CUSTOMER ALSO STATED THAT THE HAZINESS AND SCRATCHES ALL OVER THE SCREEN AND IT WAS IMPACTING TO SEE WHAT¿S ON THE SCREEN AT TIME. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8711493 ↗
  • MalfunctionMay 16, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE BUTTONS WERE NOT RESPONSIVE. THE CUSTOMER WAS ON A LADDER AND THE INSULIN PUMP FELL. THE CUSTOMER WAS UNABLE TO PRIME THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO NOT RETURN THE PRODUCT FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8614507 ↗
  • MalfunctionMay 15, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Mechanical Problem; Obstruction of Flow; Battery Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR, NO DELIVERY ALARMS, BATTERY LIFE DIMINISHED, PRIME AND REWIND TAKING LONGER. 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 8611307 ↗
  • MalfunctionMay 8, 2019Failure 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 206 MG/DL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTED THAT THEY WERE ABLE TO REWIND INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. CUSTOMER WERE ABLE TO CLEAR THE ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8589579 ↗
  • MalfunctionMay 7, 2019No Display/Image; No Display/Image

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 113 MG/DL. CUSTOMER WAS NOT CALLING BACK AFTER RECEIVING A NEW BATTERY CAP. CUSTOMER WAS ADVISED TO REVERT TO BACKUP PLAN. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8585746 ↗

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-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-1594-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
  • Z-1589-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
  • 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-1588-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
  • 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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