Paradigm® REAL-Time Revel™ MMT-723LNAB (UDI 00643169478565)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-723LNAB PRDGM V2.5B BL LN IPX7 · 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 has 39 adverse event reports describing motor errors, display problems, and power or programming issues, sometimes leading to high or low blood glucose. The reports mention 1 death and 13 injuries. There are no recalls naming 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
- 39
- Deaths reported
- 1
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00643169478565), received between Jun 2, 2017 and Aug 24, 2020 — classified as 1 death, 13 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (5 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
- Adverse Event Without Identified Device or Use Problem6
- Device Difficult to Program or Calibrate5
- Device Displays Incorrect Message5
- Mechanical Problem5
- No Display/Image5
- Patient Device Interaction Problem5
- Failure to Deliver4
- Power Problem4
Patient problems
- No Consequences Or Impact To Patient23
- Hyperglycemia12
- Hypoglycemia4
- Elevated Ketones/ Diabetic Ketoacidosis2
- Death1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2020Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10441138 ↗MalfunctionAug 12, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DRIVE SUPPORT CAP WAS NOT NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 10394747 ↗MalfunctionFeb 27, 2020Mechanical Problem; Power Problem; Mechanical Problem; Power Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. 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 9760654 ↗MalfunctionAug 28, 2019Device Alarm System; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Patient Device Interaction Problem; Device Alarm System; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP CRACK TO UPPER RIGHT CORNER OF THE DISPLAY AND CUSTOMER WERE DIFFICULT TO READ THE DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WERE HEAR THE BEEP BUT VERY FAINT BEEP. CUSTOMER STATED THAT SOMETIMES BUTTON HAS TO PRESS TWICE TO TURN THE LIGHT ON. TROUBLESHOOTING WAS DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8943191 ↗MalfunctionJun 28, 2019Power Problem; Intermittent Communication Failure; Power Problem; Intermittent Communication Failure
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP OFF NO POWER ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATE THAT DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD PUMP ERROR ALARM AND CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8743015 ↗InjuryMay 10, 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 GRANDMOTHER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 500 MG/DL AT THE TIME. THE CUSTOMER ALSO STATED THAT THEY ARE EXPERIENCING ISSUE WITH THE INSULIN PUMP. THE CUSTOMER WAS DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8598473 ↗MalfunctionMay 3, 2019Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED MULTIPLE ERROR ALERTS. 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 8576749 ↗MalfunctionApr 22, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD SWAPPING OUT BATTERIES EVERY 4 AND HALF DAYS, BUTTONS FADED AND NOT RESPOND WHEN FIRST PRESSED, REWIND WAS SLOWER, NO DELIVERY, MOTOR ERRORS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8535286 ↗DeathApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN HOSPICE CARE. THE CUSTOMER WAS HOSPITALIZED 3 WEEKS PRIOR TO PASSING. THE CAUSE OF DEATH WAS A HEART ATTACK. THE CALLER STATED THAT THE CUSTOMER HAD HEART COMPLICATIONS AND KIDNEY PROBLEMS DUE TO DIABETES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER'S BLOOD GLUCOSE WAS FLUCTUATING 3 WEEKS PRIOR TO PASSING FROM THE 60 MG/DL RANGE TO THE 400 MG/DL RANGE. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP HAD BEEN DISCONNECTED OVER A WEEK PRIOR TO PASSING. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.
Patient problems: Death; Hyperglycemia; Hypoglycemia
MAUDE report 8530594 ↗MalfunctionApr 17, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem
THE CUSTOMER'S WIFE REPORTED THAT THE INSULIN PUMP HAD KEYPAD ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL TO 300'S MG/DL. THEY REPORTED THAT THE BUTTONS WERE HARDER TO PRESS. THEY REPORTED THAT THE ACT AND ESCAPE BUTTONS WERE HARD TO PRESS, SOMETIMES HAD TO PRESS BUTTONS TWICE. THEY ALSO REPORTED THAT THE INSULIN PUMP HAD REJECTED NEW BATTERIES AND HAD UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8521764 ↗MalfunctionFeb 20, 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 THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ACT BUTTON STOPPED WORKING AFTER EXPOSURE TO MOISTURE. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED CRACK ON THE INSULIN PUMP BATTERY COMPARTMENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8355875 ↗MalfunctionNov 21, 2018Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE SCREEN HAD SCRATCHES AND IT WAS HARD TO READ. THE CUSTOMER REPORTED THAT THE SCREEN WAS CLOUDY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8093712 ↗InjuryNov 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER¿S FAMILY REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTS INSULIN PUMP WAS NOT GETTING INSULIN. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 8035964 ↗MalfunctionOct 15, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR ACT BUTTON WAS HARDER TO PRESS AND INSULIN PUMP REJECTING THE NEW BATTERIES ALSO MOTOR SOUNDS LABORED. THE 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 7965826 ↗MalfunctionSep 11, 2018Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. BLOOD GLUCOSE LEVEL WAS 120 MG/DL AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS PROVIDED. THE CUSTOMER REPORTED HAVING A FLUSHED DRIVE SUPPORT CAP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7863392 ↗MalfunctionAug 21, 2018Mechanical Problem; Mechanical Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SEVERAL ISSUES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP BATTERY LIFE DOES NOT LAST LONG, LOUDER REWIND PROCESS AND WOULD NOT COMPLETE THE REWIND PROCESS, HAD A NO DELIVERY AND MOTOR ERROR ALARMS. CUSTOMER DECLINED TROUBLESHOOTING. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7803804 ↗InjuryAug 14, 2018Adverse 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 OVER 400 MG/DL. THE CUSTOMER TREATED THROUGH INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL AND THE SENSOR GLUCOSE READING WAS 469 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING. THE SENSOR WAS NOT RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7782891 ↗InjuryAug 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INSULIN PUMP HAD AN UNRESPONSIVE ACT BUTTON. BLOOD GLUCOSE VALUE WAS 414 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER TREATED WITH INSULIN SHOTS. TROUBLESHOOTING WAS PERFORMED BUT DID NOT RESOLVE THE ISSUE. THE DEVICE WILL BE REPLACED AND RETURNED.
Patient problems: Hyperglycemia
MAUDE report 7767621 ↗MalfunctionAug 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CUSTOMER REPORTED VIA PHONE CALL THAT THE REWIND WAS TAKING LONGER. THE BLOOD GLUCOSE VALUE WAS UNKNOWN. THE PRODUCT WILL NOT RETURN FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7743572 ↗InjuryJun 22, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 575 MG/DL. THE CUSTOMER HAD SYMPTOMS SUCH AS BLURRY VISION, STOMACH PAIN AND DRY MOUTH. THE CUSTOMER WAS HOSPITALIZED DUE TO THE HIGH BLOOD GLUCOSE LEVEL OF 575 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 397 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED THAT THE HIGH BLOOD GLUCOSE LEVELS BEGAN (B)(6) 2017. THE CUSTOMER STATED HE HAD MULTIPLE NO DELIVERY ALARMS, AND CHANGED THE SET EVERY 12 HOURS. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE LEVELS WITH MANUAL INJECTIONS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING HOSPITALIZATION. THE CUSTOMER STATED THEY WERE RELEASED FROM THE HOSPITAL ON FRIDAY WITH DIABETIC KETOACIDOSIS. THE CUSTOMER STATED THEY HAD THE SAME ISSUE 2 WEEKS AG AND THE CUSTOMER DOES NOT BELIEVE IT IS THE INFUSION SETS, THE CUSTOMER THINKS THE ISSUE IS WITH THE INSULIN PUMP. THE CUSTOMER STATED THEY WOKE UP WITH A BLOOD GLUCOSE RANGING FROM 397MG/DL TO 490MG/DL. THE CUSTOMER STATED THE INSULIN PUMP EXPERIENCED MULTIPLE NO DELIVERY ALARMS, THE CUSTOMER WAS ASSISTED THROUGH TROUBLESHOOTING. THE CUSTOMER DECLINED TO CHECK FOR POSSIBLE SITE/INSULIN ISSUES. THE HIGH P
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 7628225 ↗MalfunctionApr 12, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD MULTIPLE MOTOR ERROR ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 328 MG/DL AT THE TIME OF THE INCIDENT AND DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. CUSTOMER REPORTED A MOTOR POSITION ENCODER ERROR. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7425940 ↗InjuryMar 21, 2018Failure to Deliver
CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE VALUE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 425MG/DL. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE VALUE. CUSTOMER ALSO MENTIONED ABOUT NO DELIVERY ALARM WHICH WAS THEN RESOLVED. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7356527 ↗MalfunctionFeb 6, 2018No Display/Image; Device Inoperable
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT WORKING AND HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 152 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7245777 ↗MalfunctionFeb 5, 2018Premature Discharge of Battery; Device Operates Differently Than Expected
CUSTOMER REPORTED VIA PHONE CALL FOR UNEXPECTED RESTART. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER REPORTED THAT THIS HAPPENED STARTING WITH THE LAST THREE BATTERIES AND THEY LAST MORE THAN A WEEK. CUSTOMER REPORTED THAT ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER REPORTED THAT THIS ISSUE OCCURS EVERY TIME HE CHANGES HIS BATTERY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7243179 ↗MalfunctionJan 23, 2018Loss of Power
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND AN OFF NO POWER WITHOUT THE LOW BATTERY ALERT WARNING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 170 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS ABLE TO COMPLETE THE REWIND PROCESS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7212736 ↗
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, ClassifiedParadigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
- Z-1749-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Insulin Pump (MMT-522, MMT-722)
- Z-1256-2025 · Jan 31, 2025 · Open, ClassifiedParadigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Z-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Z-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- Z-1593-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- Z-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Z-2442-2015 · Jul 22, 2015 · TerminatedGuardian 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 · TerminatedMedtronic 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 · TerminatedMedtronic 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
- Dexcom G4 Platinum Sensor 9500-27Dexcom, Inc. · Sensor, Glucose, Invasive2 recalls2 deaths99,426 reports
- Dexcom G5 Transmitter Kit STT-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 death58,932 reports
- Dexcom G5 Mobile IOS App SW10611Dexcom, Inc. · Sensor, Glucose, Invasive54,544 reports
- Dexcom G5 Transmitter 9438-06Dexcom, Inc. · Sensor, Glucose, Invasive15,360 reports
- Dexcom G5 Mobile Receiver MT22719Dexcom, Inc. · Sensor, Glucose, Invasive1 death12,594 reports
- Dexcom G4 SBT Transmitter 9438-05Dexcom, Inc. · Sensor, Glucose, Invasive1 death9,041 reports
- Dexcom G5 Mobile Receiver MT22719-BLUDexcom, Inc. · Sensor, Glucose, Invasive7,685 reports
- Dexcom G5 Mobile Receiver Kit STK-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 recall6,345 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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