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PARADIGM® REAL-time MMT-522LNABRecalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-522LNAB PRDGM INS V2.4 BL EN LK · Class 3

All models of PARADIGM REAL-time (95)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This is a Medtronic MiniMed Paradigm insulin pump. The reports mostly describe the pump having trouble with its buttons, screen, alarms and settings, along with cracks, physical damage and insulin delivery problems. There are 50 reports, with12 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
50
Deaths reported
0
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00613994407726), received between Jul 6, 2017 and Sep 1, 2023 — classified as 12 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (9 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

  • Patient Device Interaction Problem9
  • Device Difficult to Program or Calibrate8
  • Device Displays Incorrect Message7
  • Mechanical Problem7
  • Obstruction of Flow5
  • Adverse Event Without Identified Device or Use Problem4
  • Detachment of Device or Device Component3
  • Insufficient Device Problem Information3

Patient problems

  • No Consequences Or Impact To Patient33
  • Hyperglycemia13
  • Hypoglycemia4
  • Abdominal Pain1
  • Nausea1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 1, 2023Break; Break

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED A DAMAGE TO THE PUMP. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17667735 ↗
  • MalfunctionJul 31, 2020Priming Problem; Priming Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10351410 ↗
  • MalfunctionMay 21, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD BROKEN OF RESERVOIR AND BATTERY HELD, CRACK ON RESERVOIR. 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 10081346 ↗
  • MalfunctionMay 5, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR AGAIN. THEY STATED THAT SHE REPORTED IT BEFORE BUT THEN IT STARTED WORKING SO SHE KEPT USING IT. 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 10024246 ↗
  • MalfunctionApr 8, 2020Visual Prompts will not Clear; Application Program Version or Upgrade Problem; Loss of Data; Visual Prompts will not Clear; Application Program Version or Upgrade Problem; Loss of Data

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARM AND FROZEN DISPLAY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER RECEIVED A SECOND ALARM AFTER CLEARING THE ALARM. CUSTOMER REPORTED THEY WERE UNABLE TO CLEAR THE ALARM. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9937002 ↗
  • MalfunctionMar 18, 2020Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD CRACK ON THE FACING, BATTERY LIFE WAS 6 DAYS OR LESS AND INSULIN PUMP REJECTS NEW BATTERIES. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM AND SETTINGS WERE LOST. 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 9846188 ↗
  • MalfunctionFeb 18, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND INSULIN PUMP ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARMS. CUSTOMER WAS ABLE TO COMPLETE REWOUND THE INSULIN PUMP. CUSTOMER STATED THE INSULIN PUMP ALARM OCCURRED AFTER BATTERY CHANGED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 9719137 ↗
  • MalfunctionJan 21, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT WHILE AT WORK INSULIN PUMP STARTED BEEPING BUTTON ERROR. CUSTOMER STATED THAT TIME WAS NOT ADVANCED. CUSTOMER STATED THAT BY PRESSING ESC THEN ACT, BUT THE ALARM DID NOT CLEAR. 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 9609644 ↗
  • MalfunctionSep 19, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT SHE WAS SLEEPING AND THERE WAS A BUTTON ERROR AND THEN COULD NOT PRESS ANY BUTTON ON THE INSULIN PUMP. THEY STATED THAT THE KEYPAD WAS NOT RESPONDING. THE CUSTOMER STATED THAT THEY WERE NOT SURE WHETHER THE TIME ON THE INSULIN PUMP WAS ADVANCING AS THE INSULIN PUMP WAS OFF. THE CUSTOMER ALSO STATED THAT THE LIP RING WAS CRACKED. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE. THE INSULIN PUMP ALSO HAD NO DELIVERY ALARM WHICH WAS RESOLVED BY COMPLETE SET CHANGE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9085428 ↗
  • MalfunctionSep 13, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS WERE BECAME STICKY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED CRACK UNDER SCREEN. THE CUSTOMER ALSO STATED THAT THE RESERVOIR LIP RING WAS NOT DAMAGED. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE 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 9019605 ↗
  • MalfunctionJul 16, 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 INSULIN PUMP HAD NO DELIVERY ALARM AND BUTTONS WAS NOT RESPONDING AND INSULIN PUMP WAS NOT REACTING AND KEYPAD ISSUE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8792282 ↗
  • MalfunctionJul 1, 2019Mechanical Problem; Obstruction of Flow; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Obstruction of Flow; Human-Device Interface Problem; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE DEVICE WAS NOT RETURNED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8747682 ↗
  • MalfunctionJun 26, 2019No Apparent Adverse Event; No Apparent Adverse Event

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED LOW RESERVOIR ALARM WHEN IT STILL HAS INSULIN AND INSULIN PUMP ERASES SETTINGS WHEN CHANGING BATTERIES. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THERE WERE NO ALARMS OR ALERT THAT CAME UP WHEN ISSUES OCCUR. THE CUSTOMER DECLINED TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8734217 ↗
  • MalfunctionJun 7, 2019Mechanical Problem; Mechanical Problem

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SCREEN WENT BLANK THEN THEY CHANGED THE BATTERY AND SAW A MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 197 MG/DL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Hyperglycemia

    MAUDE report 8677713 ↗
  • MalfunctionMay 13, 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 230 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED OTHER BLOOD GLUCOSE LEVEL WERE 67 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 8602830 ↗
  • MalfunctionMay 8, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATES THAT 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 8589733 ↗
  • MalfunctionMay 2, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. CUSTOMER STATED THE TOP RIM OF THE RESERVOIR COMPARTMENT HAS PARTIALLY BROKEN OFF. CUSTOMER STATED THE RESERVOIR STILL LOCKS IN PLACE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE CALL BUT MENTIONED EXPERIENCING HYPOGLYCEMIA AND TREATED WITH GLUCOSE TABLETS. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW READING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Patient problems: Hypoglycemia

    MAUDE report 8572134 ↗
  • MalfunctionApr 24, 2019Display or Visual Feedback Problem; Excess Flow or Over-Infusion; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem; Display or Visual Feedback Problem; Excess Flow or Over-Infusion; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD ISSUES WITH PRIMING, ACT BUTTON WAS HARD TO PRESS, RESERVOIR WINDOW WAS CHIPPED, ISSUES WITH GIVING BOLUS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ALSO REPORTED THAT INSULIN PUMP HAD REJECTED BATTERY, BACKLIGHT DIMMER, RANDOM NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8543648 ↗
  • MalfunctionApr 23, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 10 MMOL/L. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUED THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8538892 ↗
  • MalfunctionApr 19, 2019Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SOME PARTS MISSING AND CRACKS AT AROUND RESERVOIR COMPARTMENT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WILL NEED 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 8530411 ↗
  • InjuryMar 29, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AS WELL AS ALLEGING POSSIBLE INSULIN PUMP WAS UNDER DELIVERY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 594 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 460 MG/DL AND 290 MG/DL BEFORE THE ENDING THE CALL. THE CUSTOMER PROVIDES DETAILS ON SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE LEVEL EPISODES SUCH AS NAUSEA AND ABDOMINAL PAIN. CUSTOMER WAS TREATED WITH INSULIN PUMP MANUAL INJECTION. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT THE CANNULA WAS BENT. CUSTOMER DECLINED TO CHECK FOR THE PRESENCE OF LEAKS OR AIR BUBBLES IN THE TUBING OR RESERVOIR. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE LEVEL AND UNDER DELIVERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: Abdominal Pain; Hyperglycemia; Nausea

    MAUDE report 8463112 ↗
  • MalfunctionFeb 26, 2019Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND MOTOR POSITION ENCODER ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. THE TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED AND TO DISCONTINUE USE OF THE INSULIN PUMP AND RECOMMENDED CUSTOMER TO REFER TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8372740 ↗
  • MalfunctionFeb 26, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

    THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTON ERROR. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 130 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8369190 ↗
  • MalfunctionFeb 13, 2019Failure to Cycle; Failure to Cycle

    THE CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER REPORTED THAT DURING SEATING THE FORCE SENSOR DID NOT DETECT THE RESERVOIR. 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 8334452 ↗
  • MalfunctionJan 28, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGE AT RESERVOIR CHAMBER. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS BETWEEN 100 MG/DL TO 150 MG/DL. CUSTOMER REPORTED DAMAGE TO THE INSULIN PUMP. CUSTOMER WAS ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED 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 8280913 ↗

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-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-1594-2020 · Jun 27, 2019 · Open, Classified
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
  • 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-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

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Sources and updates

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