Skip to content

Paradigm® REAL-Time Revel™ MMT-723NAH (UDI 00643169446441)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-723NAH PRDGM V2.5B PK US PR · 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 insulin pump has 146 FDA adverse event reports, including 2 deaths and 45 injuries. Many describe the pump displaying incorrect messages, being hard to program, sticking buttons, and motor or no-delivery alarms. Some reports mention high blood sugar, and many list no consequences for the patient. 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
146
Deaths reported
2
Injuries reported
45
Recalls naming it
0

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 00643169446441), received between Jun 6, 2017 and May 29, 2020 — classified as 2 deaths, 45 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (26 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 Message26
  • Device Difficult to Program or Calibrate25
  • Patient Device Interaction Problem22
  • Mechanical Problem20
  • Adverse Event Without Identified Device or Use Problem15
  • Power Problem15
  • No Display/Image14
  • Obstruction of Flow14

Patient problems

  • No Consequences Or Impact To Patient86
  • Hyperglycemia49
  • Hypoglycemia10
  • Death2
  • Elevated Ketones/ Diabetic Ketoacidosis2
  • Blood Loss1
  • No Known Impact Or Consequence To Patient1
  • Skin Irritation1

Recent adverse event reports

The 25 most recent of 146 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 29, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 451 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS NOT ABLE TO COMPLETE REWIND. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 10100378 ↗
  • MalfunctionMay 26, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE STICKING. 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 10086329 ↗
  • InjuryFeb 5, 2020Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 497 MG/DL. CUSTOMER STATED THAT INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9674542 ↗
  • InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 440 MG/DL AT THE TIME OF INCIDENT. CUSTOMER DECLINED TO TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE VALUE. CUSTOMER STATED THAT YESTERDAY THEY STILL GOT PLENTY OF INSULIN AND THERE WAS NO DELIVERY ALARM ON INSULIN PUMP. THE INSULIN PUMP WILL NOT RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9573729 ↗
  • MalfunctionDec 31, 2019Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP RECEIVED RANDOM NO DELIVERY ALARM THREE TIMES PER WEEK, BATTERY WAS HARD TO GET IN AND PUMP WAS BROKEN ON THE SIDE AS WELL AS INSULIN PUMP TAKES LONGER REWIND. 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 9534567 ↗
  • MalfunctionDec 25, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT PUMP HAS BEEN EXPOSED TO STRONG MAGNETIC FIELD. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS UNABLE TO COMPLETE INSULIN PUMP REWIND. THE INSULIN PUMP WILL NOT BE RETURN. ADVISE TO DISCONTINUE THE INSULIN PUMP AND REVERT TO BACKUP PLAN AS PER HEALTH CARE PROFESSIONALS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9517963 ↗
  • MalfunctionDec 23, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PHASE OF THE BUTTONS WERE WORN AND THEY SOUND CRACKLY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPLACED THE BATTERIES EVERY 5-6 DAYS MORE FREQUENTLY. THE CUSTOMER REPORTED CRACK ON RESERVOIR PORT THAT EXTENDED TOWARDS FRONT OF THE INSULIN PUMP CASING. THE INSULIN PUMP HAD RANDOM UNEXPLAINED NO DELIVERY ALARMS AND THE MOTOR WAS LOUDER DURING REWIND. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9509722 ↗
  • MalfunctionDec 19, 2019Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SCREEN HAD SCRATCHED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED BATTERY LIFE DIMINISHED AND UNEXPLAINED NO DELIVERY ALERTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9493071 ↗
  • MalfunctionNov 20, 2019Mechanical Problem; Obstruction of Flow; Priming Problem; Mechanical Problem; Obstruction of Flow; Priming Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR, THE INSULIN PUMP QUIT WORKING, THE INSULIN PUMP DID NOT LOAD AND GIVE INSULIN DELIVERY AFTER REWINDING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 375 MG/DL. THE CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9351725 ↗
  • MalfunctionNov 13, 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 THAT THE BUTTONS WERE HARD TO PUSH AND STICK. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PUMP HAD NO DELIVERY ALARM AS WELL AS REWINDING WAS SLOWER AND LOUDER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9313942 ↗
  • MalfunctionOct 23, 2019No Display/Image; Power Problem; Patient Device Interaction Problem; No Display/Image; Power Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN SLIGHTLY MAKING HARD TO SEE THE SCREEN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE PLASTIC ON CLIP ENTRY CHIPPED OFF. THE INSULIN PUMP HAD WORN BATTERY AND RESERVOIR ENTRY. THE INSULIN PUMP BATTERIES WOULD LAST LESS THAN A WEEK AND REJECTED NEW BATTERIES. THE CUSTOMER REPORTED THAT THE INSULIN PUMP REWIND WOULD TAKE LONGER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9223949 ↗
  • MalfunctionOct 2, 2019Mechanical Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Power Problem; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP TURNS OFF RANDOMLY, REWIND STOPS INTERMITTENTLY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARM, SHOWING INACCURATE INFORMATION REGARDING THE RESERVOIR, BATTERY COMPARTMENT HAD CRACK, REWIND TAKE LONGER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9143711 ↗
  • MalfunctionOct 1, 2019Failure to Cycle; Battery Problem; Patient Device Interaction Problem; Failure to Cycle; Battery Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE BATTERY AREA OF INSULIN PUMP WAS CRACKED AND HAD TO CHANGE BATTERY MORE FREQUENTLY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9139172 ↗
  • MalfunctionSep 13, 2019Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD SCRATCHES ON SCREEN MAKING IT DIFFICULT TO READ AT CERTAIN ANGLES. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARM, REJECTED BATTERIES, REWIND WAS SLOWER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9021114 ↗
  • MalfunctionSep 2, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP¿S BUTTON WAS HARDER TO PRESS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP REQUIRED MORE REWIND THAN ONCE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8953332 ↗
  • MalfunctionAug 30, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP'S KEYPAD WAS UNRESPONSIVE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT ALL THE BUTTONS WERE NOT RESPONDING. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING. 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 8948944 ↗
  • MalfunctionAug 23, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP BUTTON WAS HARDER TO PUSH. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8924350 ↗
  • MalfunctionAug 2, 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 200 MG/DL. THE CUSTOMER REPORTED THAT THE BUTTONS WERE NOT WORKING PROPERLY. 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 8854055 ↗
  • MalfunctionJul 25, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD STUCK BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. 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 8825510 ↗
  • InjuryJul 10, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

    CUSTOMER REPORTED VIA PHONE CALL THAT THE THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL AND 450 MG/DL. CUSTOMER ALSO HAD AN ISSUE WITH NO DELIVERY ALARM. ASSISTED CUSTOMER IN PERFORMING A 5.0 UNIT FIXED PRIM AND THE INSULIN WAS EXITED. CUSTOMER STATES THE CANNULA WAS NOT BENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8774700 ↗
  • MalfunctionJun 28, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 313 MG/DL. CUSTOMER STATES THEY ARE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATES DRIVE SUPPORT CAP APPEARS TO BE NORMAL. CUSTOMER STATES INSULIN PUMP HISTORY CONTAINS MORE THAN ONE MOTOR ERROR WITHIN 30 DAYS. CUSTOMER REPORTED NO DELIVERY ALARM. CUSTOMER REPORTS EVENT WAS RESOLVED BY CHANGING COMPLETE SET. CUSTOMER ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8743535 ↗
  • MalfunctionJun 5, 2019No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

    IT WAS REPORTED THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200 MG/DL AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8669497 ↗
  • InjuryJun 4, 2019Mechanical Problem; Mechanical Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS FROM 300 MG/DL TO 400 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THEY RECEIVED MOTOR ERROR. CUSTOMER WAS ABLE TO CLEAR ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER DID NOT REPORT MOTOR POSITION ENCODER ERROR ALARM. CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING TO HIGH BLOOD GLUCOSE EPISODE. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8666076 ↗
  • InjuryJun 4, 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 AS WELL AS CUSTOMER¿S BLOOD GLUCOSE MONITOR STOPPED WORKING. CUSTOMER STATED THAT WHEN THEY FIRST CHECKED BLOOD GLUCOSE IT WAS 534 MG/DL AND THEN IT EVENTUALLY STOPPED WORKING. CUSTOMER STATED THAT THEY HAS BEEN WEARING THE SENSOR THE WHOLE TIME, BUT DID NOT BEEN ABLE TO USE IT. CUSTOMER DECLINED TROUBLESHOOTING AND ADVICE HIGH BLOOD GLUCOSE. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8666018 ↗
  • MalfunctionMay 21, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF THE INSULIN PUMP WERE HARD TO PUSH. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD SCRATCHED SCREEN AND THE BATTERY CAP WAS HARD TO GET OFF. THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERIES ALARMS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8626987 ↗

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-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-1587-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
  • Z-1593-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
  • 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-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