Skip to content

Paradigm® REAL-Time Revel™ MMT-723LNAB (UDI 00643169933132)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-723LNAB PRDGM 3.0 BL EN LN · 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 is worn by people with diabetes to deliver insulin. Its 149 reports mostly describe blood sugar going too high or too low, and some mention a cracked battery chamber, buttons that did not respond, and pump errors. The reports include 81 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
149
Deaths reported
0
Injuries reported
81
Recalls naming it
0

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 00643169933132), received between Dec 15, 2017 and Jul 7, 2025 — classified as 81 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (23 reports).

14 other recalls cover devices cleared under the same FDA submission (P150019, 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: 0 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: 1 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

  • Adverse Event Without Identified Device or Use Problem43
  • No Apparent Adverse Event34
  • Device Difficult to Program or Calibrate23
  • Patient Device Interaction Problem21
  • Mechanical Problem18
  • Obstruction of Flow16
  • Power Problem10
  • No Display/Image8

Patient problems

  • Hyperglycemia64
  • No Consequences Or Impact To Patient61
  • Hypoglycemia23
  • Elevated Ketones/ Diabetic Ketoacidosis4
  • Chest Pain2
  • Dizziness1
  • Insufficient Information1
  • Irritation1

Recent adverse event reports

The 25 most recent of 149 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND CHEST PAIN. THE BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 306 MG/DL. THE CUSTOMER WAS TREATED WITH AN INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. IT IS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1715K WAS REQUESTED AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED.

    Patient problems: Chest Pain; Hyperglycemia

    MAUDE report 22409475 ↗
  • MalfunctionFeb 3, 2021Material Integrity Problem; Material Integrity Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BATTERY CAP WAS DAMAGED . THE CUSTOMER STATED THAT SHE WAS UNABLE TO REMOVE THE BATTERY CAP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Insufficient Information

    MAUDE report 11273719 ↗
  • MalfunctionJul 23, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DOWN ARROW WAS NOT RESPONSIVE AND CLICKY, SCRATCHES ON THE SCREEN OF INSULIN PUMP THAT MAKE IT HARD TO READ, INSULIN PUMP LOUDER DURING THE REWOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10312505 ↗
  • InjuryJul 6, 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 REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 40 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER HAD A CRACK ON THE BATTERY CHAMBER. CUSTOMER DECLINED TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 10231916 ↗
  • InjuryJul 3, 2020No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

    THE CUSTOMER'S NURSE PRACTITIONER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 43 MG/DL. CUSTOMER WAS TREATED WITH FOOD. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD CRACK ON THE BATTERY CHAMBER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 10229040 ↗
  • InjuryJul 3, 2020Premature Discharge of Battery; Loss of Data; No Apparent Adverse Event; Patient Device Interaction Problem; Premature Discharge of Battery; Loss of Data; No Apparent Adverse Event; Patient Device Interaction Problem

    THE CUSTOMER'S NURSE REPORTED VIA PHONE CALL THAT THEY HAD A LOW BLOOD GLUCOSE VALUE OF 49 MG/DL. CUSTOMER STATED THAT THE BATTERY COMPARTMENT WAS CRACKED. CUSTOMER STATED THAT THE INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. THE CUSTOMER WAS TREATED WITH FOOD. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 10228841 ↗
  • InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    CUSTOMER'S NURSE REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 48 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED BECAUSE THE INSULIN PUMP WAS DAMAGED AND BEING REPLACED. THE CUSTOMER WAS TREATED WITH FOOD. CUSTOMER STATED THAT HAD A CRACK ON THE BATTERY CHAMBER OF THE INSULIN PUMP. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 10228816 ↗
  • InjuryJul 3, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 52 MG/DL. THE CUSTOMER TREATED LOW BLOOD GLUCOSE LEVEL BY EATING FOOD. THE CUSTOMER ALSO REPORTED THAT THERE WAS A CRACK ON THE BATTERY CHAMBER OF THE INSULIN PUMP. THE CUSTOMER DECLINED TROUBLESHOOTING FOR INSULIN PUMP AS THE INSULIN PUMP WAS DAMAGED AND WAS BEING REPLACED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 10228801 ↗
  • InjuryJul 3, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

    THE CUSTOMER'S NURSE REPORTED VIA PHONE CALL THAT CUSTOMER WERE EXPERIENCING LOW BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 41 MG/DL. CUSTOMER TREATED WITH FOOD. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER STATED INSULIN PUMP HAD CRACK ON THE BATTERY CHAMBER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 10228618 ↗
  • InjuryJun 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 403 MG/DL. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS LOOSE. CUSTOMER STATED THAT THE INSULIN PUMP RESTARTED WITHOUT ANY ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 10198900 ↗
  • InjuryJun 19, 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 REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 684 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INFUSION SETS WERE LEAKING AT SITES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 10176065 ↗
  • InjuryJun 1, 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 REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 684 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INFUSION SETS WERE LEAKING AT SITES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 10104299 ↗
  • MalfunctionMay 11, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER STATED THAT THE ACT BUTTON WAS NOT WORKING. CUSTOMER STATED THE TIME CLOCK WAS ADVANCED. 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 10045878 ↗
  • InjuryApr 23, 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 REPORTED VIA PHONE CALL THAT THE THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S LOW BLOOD GLUCOSE WAS 42 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 9989480 ↗
  • InjuryApr 23, 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 REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 42 MG/DL TO 70 MG/DL AT THE TIME OF INCIDENT. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE. CUSTOMER REPORTED THAT INSULIN PUMP WAS NOT OVER DELIVERING. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER PERFORMED THE DISPLACEMENT TEST AND THE TEST WAS PASSED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 9989474 ↗
  • MalfunctionMar 16, 2020Failure to Cycle; Mechanical Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Failure to Cycle; Mechanical Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER STATED THE BATTERY WAS NOT PREVIOUSLY USED. CUSTOMER STATED THE THEY RECEIVED NO DELIVERY ALARM WHEN REWINDING THE INSULIN PUMP. CUSTOMER STATED THE INSULIN SQUIRT OUT DURING MANUAL PRIME. CUSTOMER STATED THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THEY DID NOT RECEIVE 2ND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9833832 ↗
  • MalfunctionFeb 25, 2020Mechanical Problem; Mechanical Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM DURING BASAL. THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO REWIND THE INSULIN PUMP. THE DRIVE SUPPORT CAP APPEARED NORMAL. 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 9749380 ↗
  • InjuryFeb 13, 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 REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 47 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH FOOD FOR LOW BLOOD GLUCOSE. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THEY DID NOT ALLEGING INSULIN PUMP FOR OVER DELIVER. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER HAD A KIDNEY FAILURE, HEART FAILURE AND GALL BLADDER WAS REMOVED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia; Renal Failure

    MAUDE report 9704308 ↗
  • MalfunctionFeb 4, 2020Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

    IT WAS REPORTED VIA PHONE CALL BY THE CUSTOMER'S SPOUSE THAT THE CUSTOMER'S INSULIN PUMP WAS NOT DELIVERING INSULIN CORRECTLY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. NO FURTHER INFORMATION WAS PROVIDED. TROUBLESHOOTING WAS NOT COMPLETED AS THE CALLER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9663679 ↗
  • MalfunctionJan 14, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Priming Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE LESS RESPONSIVE AND THE INSULIN SQUIRING OUT WHEN PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9589604 ↗
  • MalfunctionJan 14, 2020Computer Software Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Computer Software Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MANY MALFUNCTIONS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN PUMP HAD BUTTON ERRORS, REJECTED BATTERIES, RESERVOIR WAS ALWAYS BREAKING AND PIECE WAS COMING OFF, PUMP WAS REJECTING BATTERIES, PUMP WAS FORCING REWIND, THERE WERE NO DELIVERY ALARMS, IT LOCKED UP AND HAD NO RESPONSE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9585897 ↗
  • MalfunctionJan 14, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT RESERVOIR COMPARTMENT OF INSULIN PUMP WAS CRACKED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT RESERVOIR DID NOT LOCK IN PLACE WHILE INSERTED. 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 9584979 ↗
  • MalfunctionJan 14, 2020Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 137 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THEY WERE NOT ABLE TO REWIND INSULIN PUMP DUE TO INSULIN PUMP ERROR ALARM. CUSTOMER STATED DRIVE SUPPORT CAP APPEARS NORMAL. TROUBLESHOOTING 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9584827 ↗
  • MalfunctionJan 3, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE THAT INSULIN PUMP ALL BUTTONS WERE HARD TO PRESSED ESPECIALLY THE ACT AND B BUTTON. CUSTOMER¿S BLOOD GLUCOSE WAS 202 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED FOR KEYPAD ANOMALY. 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 9543391 ↗
  • MalfunctionDec 30, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS OF INSULIN PUMP WAS DIFFICULT TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT SCREEN WAS DAMAGED TO THE POINT THAT IT WAS DIFFICULT TO READ. CUSTOMER ALSO STATED THAT BACK LIGHT NO LONGER WORKS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9529678 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150019, 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-1592-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
  • Z-1589-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
  • Z-1587-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
  • Z-1594-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
  • Z-1591-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
  • 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

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