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Paradigm® REAL-Time Revel™ MMT-723RNAP (UDI 00643169476660)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-723RNAP PRDGM V2.5B PL EN RH X7 · 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 Paradigm insulin pump delivers insulin and reports mostly describe buttons that stop responding, cracks in the casing, battery failures, and insulin not being delivered, sometimes alongside high blood sugar. There are 82 reports describing 1 death and 33 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
82
Deaths reported
1
Injuries reported
33
Recalls naming it
0

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00643169476660), received between Jun 20, 2017 and Jul 16, 2020 — classified as 1 death, 33 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (14 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

  • Mechanical Problem14
  • Patient Device Interaction Problem13
  • Adverse Event Without Identified Device or Use Problem12
  • Device Difficult to Program or Calibrate11
  • No Apparent Adverse Event10
  • Obstruction of Flow10
  • Device Displays Incorrect Message9
  • Battery Problem7

Patient problems

  • No Consequences Or Impact To Patient44
  • Hyperglycemia32
  • Hypoglycemia6
  • Death1
  • Dizziness1
  • Seizures1

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 16, 2020Excess Flow or Over-Infusion; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Excess Flow or Over-Infusion; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS WERE UNRESPONSIVE WHEN CUSTOMER PRESSES. THE CUSTOMER STATED RESERVOIR PISTON WAS NOT PUSHING UP PROPERLY SO INSULIN WAS NOT BEING DELIVERED, CRACK ABOVE RIGHT SIDE TOP CORNER BESIDES THE SCREEN. 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 10281405 ↗
  • MalfunctionJan 20, 2020Material Integrity Problem; Power Problem; Patient Device Interaction Problem; Material Integrity Problem; Power Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK WHERE THE BATTERY GOES IN. THE CUSTOMER STATED THAT THE INSULIN PUMP DID NOT TURN ON AND ALSO BATTERY CAP WAS DAMAGED. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. 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 9605611 ↗
  • InjuryDec 18, 2019No Display/Image; Material Integrity Problem; No Apparent Adverse Event; No Display/Image; Material Integrity Problem; No Apparent Adverse Event

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND INSULIN PUMP HAD BLANK SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 537 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS THAT HER BATTERIES ARE GOING DEAD ON THE INSULIN PUMP AND THEY CHANGING THE BATTERY. CUSTOMER STATED THAT INSULIN PUMP WAS NOT EXPOSED TO MOISTURE. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP ARE DAMAGED. 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 NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9488479 ↗
  • MalfunctionDec 18, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS LESS RESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD SOMETIMES PRESS BUTTONS TWICE AND UNEXPLAINED NO DELIVERY ALERTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9486255 ↗
  • InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 503 MG/DL. CUSTOMER EXPERIENCED DIZZINESS DURING HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NOT USING INSULIN PUMP WITHIN 48 HOURS OF HIGH BLOOD GLUCOSE EVENT. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Dizziness; Hyperglycemia

    MAUDE report 9415598 ↗
  • MalfunctionNov 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 290 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER ALSO REPORTED THAT THEY WERE ABLE TO CLEAR AND NOT ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED 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 9360373 ↗
  • MalfunctionNov 15, 2019Display or Visual Feedback Problem; Obstruction of Flow; Battery Problem; Connection Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Battery Problem; Connection Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR SOMETIMES WAS LOOSE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. IT WAS REPORTED THAT THE BATTERY LIFE DECREASED. THE TOP HAD CRACK ON IT AND THE BACK LIGHT WAS NOT AS BRIGHT. THE INSULIN PUMP WAS SLOWER AND LOUDER TO REWIND AND HAD UNEXPLAINED AND RANDOM NO DELIVERY ALARMS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9325953 ↗
  • MalfunctionNov 15, 2019Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Connection Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Connection Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR SOMETIMES WAS LOOSE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. IT WAS REPORTED THAT THE BATTERY LIFE DECREASED. THE TOP HAD CRACK ON IT AND THE BACK LIGHT WAS NOT AS BRIGHT. THE INSULIN PUMP WAS SLOWER AND LOUDER TO REWIND AND HAD UNEXPLAINED AND RANDOM NO DELIVERY ALARMS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9325946 ↗
  • MalfunctionNov 12, 2019Premature Discharge of Battery; Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Battery Problem; Premature Discharge of Battery; Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Battery Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF THE INSULIN PUMP WERE HARDER TO PRESS AND MOTOR ERRORS ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE MOTOR SOMETIMES MAKES GRINDING AND SCREECHING NOISE SOMETIMES. CUSTOMER ALSO STATED THAT SOMETIMES THE INSULIN PUMP DELIVERED LESS INSULIN, SOMETIMES HE LOSES DATE, TIME, AND DATA AFTER CHANGING THE BATTERIES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9313555 ↗
  • MalfunctionNov 1, 2019Device Difficult to Program or Calibrate; Detachment of Device or Device Component; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Detachment of Device or Device Component; Patient Device Interaction Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP BUTTONS WERE NOT WORKING AND DRIVE SUPPORT CAP WAS FLUSH. CUSTOMER¿S HIGH BLOOD GLUCOSE WAS 271 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS TREATED WITH SYRINGE. THE CUSTOMER STATED THAT BATTERY COMPARTMENT WAS CLACK. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT INSULIN PUMP HAD KEYPAD ISSUE. ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9265309 ↗
  • MalfunctionOct 20, 2019Mechanical Problem; Environmental Compatibility Problem; Mechanical Problem; Environmental Compatibility Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 190 MG/DL. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT SHE FORGOT TO TAKEN OFF THE INSULIN PUMP WHILE SHE WENT ON MAGNETIC RESONANCE IMAGING. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WOULD NEED TO BE REPLACED, TO DISCONTINUE USE OF THE INSULIN PUMP AND REFER TO BACK UP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9212390 ↗
  • MalfunctionOct 5, 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

    IT WAS REPORTED VIA PHONE CALL THAT THE WEIGHT HAS BEEN CHANGED TO (B)(6).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9159835 ↗
  • MalfunctionOct 3, 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 HAD NO DELIVERY ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A BUTTON ERROR ALARM. CUSTOMER REPORTED THAT THE BUTTONS WEARING OFF AND ESCAPE BUTTON HARDER TO PRESS AND REWIND WAS LOUDER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9149575 ↗
  • MalfunctionOct 1, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED A MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM. CUSTOMER REPORTED THAT THE INSULIN SQUIRT SOMETIMES WHEN PRIMING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9138163 ↗
  • MalfunctionSep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING UNKNOWN ISSUE WITH THE INSULIN FROM THE (B)(6) OF THE FAMILY. THE INFORMATION WAS RECEIVED ON (B)(6) 2019. THE CUSTOMER WAS USING A MEDTRONIC MINIMED PARADIGM PUMP. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9133045 ↗
  • InjurySep 27, 2019Adverse 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 LEVEL OF 400 MG/DL. CUSTOMER STATED SHE TALKED WITH HER HEALTHCARE PROFESSIONAL AND THEY WENT OVER THE ISSUES. CUSTOMER GOT A NO DELIVERY ALARM AND HER BLOOD GLUCOSE WENT HIGH. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9127360 ↗
  • MalfunctionSep 20, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR COMPARTMENT WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED THE RESERVOIR DID NOT LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WOULD NEED TO BE REPLACED, TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9096385 ↗
  • MalfunctionSep 13, 2019Mechanical Problem; Mechanical Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 136 MG/DL. CUSTOMER STATED THAT THEY DID THE TROUBLESHOOTING LAST WEEK AND IT SEEMS LIKE THAT PUMP RECOVERED. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATED THAT INSULIN PUMP HAD NOT BEEN EXPOSED TO HIGH MAGNETIC FIELD. THE PUMP HAS BEEN EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9020516 ↗
  • InjurySep 6, 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 THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS OF 46 MG/DL. THE CUSTOMER TREATED LOW BLOOD GLUCOSE WITH ORANGE JUICE. CUSTOMER DECLINED TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 8969966 ↗
  • MalfunctionSep 5, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD STICKY BUTTONS AND HAD TO HOLD HARDER TO GET RESPONSE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THEY ALSO REPORTED THAT THE GEAR WAS SLOWER WHEN PRIMING, SQUIRTED INSULIN WHEN PRIMING THE INSULIN PUMP INTERMITTENTLY, HAD NICKS IN TOP RESERVOIR AREA. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8963891 ↗
  • MalfunctionSep 5, 2019Device Difficult to Program or Calibrate; No Apparent Adverse Event; Device Difficult to Program or Calibrate; No Apparent Adverse Event

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE KEYPAD WAS LESS RESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED REWIND WAS SLOWER THAN IN THE PAST, HAD RECEIVED LOW BATTERY ALERT AFTER A WEEK. CUSTOMER DECLINED TRANSFER TO 24HR TROUBLESHOOT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8963573 ↗
  • MalfunctionAug 16, 2019Failure to Cycle; Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Failure to Cycle; Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND SLOWER TO REWIND WHEN PRIMING. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN PUMP HAD SCRATCHES ON SCREEN AND UNEXPLAINED NO DELIVERY ALARM. CUSTOMER STATED INSULIN PUMP HAD INSULIN SQUIRTING OUT WHILE PRIMING AND LOST SETTING MULTIPLES TIMES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8900476 ↗
  • MalfunctionAug 13, 2019Power Problem; Power Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP KEEP SHUTTING OFF ON ITS OWN AND IT NEED TO SET UP ALL THE TIME ALL OVER AGAIN. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8887351 ↗
  • MalfunctionMay 27, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RECEIVED MOTOR ERROR ALARMS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8643941 ↗
  • MalfunctionMay 16, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

    THE CUSTOMER'S HUSBAND REPORTED VIA PHONE CALL THAT THERE WAS CRACK ON RESERVOIR COMPARTMENT AND HAD BROKEN PIECES. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE. 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. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8614509 ↗

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-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-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-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-1592-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
  • Z-1593-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
  • 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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