Skip to content

Paradigm® REAL-Time Revel™ MMT-523NAP (UDI 00643169202337)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-523NAP PRDGM INS V2.5 PL 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 Medtronic MiniMed Paradigm REAL-Time Revel insulin pump has 106 reports, including 1 death and 33 injuries. Many reports describe incorrect messages on the display, and some describe battery power loss, sticking buttons, or motor errors during priming. Some patients were reported to have high blood sugar, and one report describes diabetic ketoacidosis. The latest report is dated May 2024. 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
106
Deaths reported
1
Injuries reported
33
Recalls naming it
0

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 00643169202337), received between Jun 8, 2017 and May 12, 2024 — classified as 1 death, 33 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (33 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 Message33
  • Patient Device Interaction Problem13
  • Device Difficult to Program or Calibrate9
  • Break7
  • Device Operates Differently Than Expected7
  • Mechanical Problem7
  • Adverse Event Without Identified Device or Use Problem6
  • Crack5

Patient problems

  • No Consequences Or Impact To Patient64
  • Hyperglycemia32
  • Hypoglycemia8
  • No Known Impact Or Consequence To Patient3
  • Vomiting2
  • Death1
  • Elevated Ketones/ Diabetic Ketoacidosis1
  • Nausea1

Recent adverse event reports

The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 12, 2024Power Problem; Power Problem

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED UNEXPECTED BATTERY POWER LOSS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE TROUBLESHOOTING WAS PERFORMED. THE EVENT INVOLVED PRODUCT(S) MMT-523NAP. REPORTED ISSUE RESOLVED NO ESCALATION REQUIRED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-523NAP. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE OR DISCONTINUE TO USE OF THE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19295628 ↗
  • MalfunctionJul 16, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP DID NOT TURN ON AND THAT THERE WAS DAMAGE NEAR THE BATTERY COMPARTMENT. TROUBLESHOOTING WAS DECLINED. 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 10281983 ↗
  • MalfunctionMay 21, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BATTERY COMPARTMENT WAS CRACKED. 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 10081369 ↗
  • MalfunctionFeb 20, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP¿S BUTTONS WERE STICKING OR NON-RESPONSIVE, PRIME OR REWIND MAKING LOUD AND UNUSUAL GRINDING NOISE AND INSULIN PUMP RECEIVED MOTOR ERRORS. 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 9731619 ↗
  • MalfunctionSep 20, 2019Failure to Cycle; Failure to Cycle

    THE CUSTOMERS MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 164 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 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 DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9098551 ↗
  • MalfunctionSep 9, 2019Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PUMP ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT CRACKED OR SCRATCHES ON THE SCREEN OF INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8974214 ↗
  • MalfunctionSep 5, 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 UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT INSULIN PUMP SHUT OFF. CUSTOMER WAS NOT ABLE TO TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8963939 ↗
  • InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HYPERGLYCEMIA LEADING TO DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 73 MG/DL AND 700 MG/DL AT THE TIME OF INCIDENT AND VOMITING. THE CUSTOMER REPORTED THAT THEY HAD TO REPLACE THE BATTERY FROM TIME TO TIME AND MAYBE THE REASON WHY SHE WAS NOT ABSORBING THE INSULIN BY THAT TIME. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia; Vomiting

    MAUDE report 8877905 ↗
  • MalfunctionJul 19, 2019Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM AND FREEZING THE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE ALL BUTTONS EFFECTED. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO DISCONTINUE USE OF THE INSULIN 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 8806261 ↗
  • InjuryJul 5, 2019Material Integrity Problem; No Apparent Adverse Event; Patient Device Interaction Problem; Material Integrity Problem; No Apparent Adverse Event; Patient Device Interaction Problem

    THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS OVER 400 MG/DL AND 54 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE VALUE WAS 49 MG/DL. THE CUSTOMER ALSO REPORTED THAT CRACKS ON THE BATTERY COMPARTMENT AND RESERVOIR COMPARTMENT. THE CUSTOMER ALSO STATED THAT INSULIN PUMP WAS NOT DELIVER INSULIN. THE CUSTOMER WAS ADVISED TO REPLACE AND 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: Hyperglycemia; Hypoglycemia

    MAUDE report 8763315 ↗
  • MalfunctionJun 20, 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 INSULIN PUMP BUTTONS WERE LESS RESPONSIVE AND HIT MULTIPLE TIMES AS WELL AS HARDER TO RESPOND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT TIME OF INCIDENT. THE CUSTOMER STATED THAT INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED BE FOR THE ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8715820 ↗
  • MalfunctionJun 20, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND A MOTOR POSITION ENCODER ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THEY HAD MOTOR ERROR. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE CUSTOMER WAS ABLE TO REWIND. THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARM HISTORY CONTAINS BOTH AN MOTOR POSITION ENCODER ERROR ALARM AND MORE THAN ONE MOTOR ERROR ALARM WITHIN A 30 DAY PERIOD. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. 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 8715157 ↗
  • MalfunctionJun 10, 2019Priming Problem; Priming Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD PRIME ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 202 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE PUMP WAS NOT DETECTING THE RESERVOIR AND IT KEPT GOING UP. THE CUSTOMER REPORTED THAT THE INSULIN WAS COMING OUT OF THE RESERVOIR AND TUBING BUT THE PUMP WAS NOT DETECTING THE INSULIN COMING OUT OF THE PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8682108 ↗
  • MalfunctionJun 5, 2019Premature Discharge of Battery; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ISSUES AND UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 225 MG/DL 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 REWIND. CUSTOMER REPORTED THAT THE BUTTONS 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 8673074 ↗
  • MalfunctionJun 4, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE THAT THE BUTTONS WERE STOPPED WORKING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE TIME WAS ADVANCING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8665724 ↗
  • MalfunctionJun 3, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER'S FAMILY WAS REPORTED VIA PHONE CALL THAT, THE INSULIN PUMP HAD KEYPAD ISSUES. THE BLOOD GLUCOSE WAS 240 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT, THE PUMP IS NOT EXPOSE TO MOISTURE OR THE BUTTON CONTINUES TO SCROLL WITHOUT PRESSING IT AND BUTTONS ARE NOT RESPONDING. THE TROUBLESHOOTING WAS DETERMINED THAT, THE INSULIN PUMP SHOULD BE REPLACED. 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 8662334 ↗
  • MalfunctionApr 22, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED BUTTON ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 181 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER STATED THAT THE BUTTONS ARE NOT RESPONDING. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED AND TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8535072 ↗
  • MalfunctionApr 11, 2019Device Alarm System; Power Problem; Device Alarm System; Power Problem

    CUSTOMER¿S DAUGHTER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AUDIO ANOMALY. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP LOST SOME LOUDNESS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8502919 ↗
  • MalfunctionApr 2, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP NOT DELIVERING CORRECT AMOUNT OF INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8472314 ↗
  • InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER¿S NURSE REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETO ACIDOSIS ON (B)(6) 2019 WITH BLOOD GLUCOSE LEVEL OF 432 MG/DL. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 179 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA AND VOMITING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia; Nausea; Vomiting

    MAUDE report 8411334 ↗
  • MalfunctionFeb 12, 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 386 MG/DL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. CUSTOMER TROUBLESHOOT WAS PERFORMED. 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 8334182 ↗
  • MalfunctionJan 31, 2019Connection Problem; Connection Problem

    THE CUSTOMER REPORTED VIA CALL THAT THE RESERVOIR RING WAS LOOSENED AND SQUIRT INSULIN INSTEAD OF DRIPPING DURING PRIME. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATE THAT RESERVOIR WAS NOT SECURE. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8291818 ↗
  • MalfunctionJan 17, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT HALF OF THE RESERVOIR COMPARTMENT IS MISSING. IT WAS NOT STATED IF THE RESERVOIR WAS ABLE TO LOCK IN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8259283 ↗
  • MalfunctionDec 27, 2018Computer Software Problem; Mechanical Problem; Obstruction of Flow; Computer Software Problem; Mechanical Problem; Obstruction of Flow

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR AND PUMP ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM AND DIMINISHED BATTERY LIFE. IT WAS REPORTED THAT THEY HAD PUMP ERROR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8200320 ↗
  • MalfunctionDec 25, 2018Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DAMAGE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP HAD BATTERY LIFE DIMINISHED, O RING FROM RESERVOIR AREA MISSING AND INSULIN PUMP HAD RANDOM NO DELIVERY ALARMS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8194832 ↗

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-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-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-1588-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
  • 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-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

Other Sensor, glucose, invasive devices

All Sensor, glucose, invasive devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page