Paradigm® REAL-Time Revel™ MMT-723NAH (UDI 00643169202368)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-723NAH PRDGM INS V2.5 PK EN · 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 REAL-Time Revel insulin pump has 130 adverse event reports on record, with no deaths and 43 injuries. The reports mostly describe incorrect on-screen messages, unresponsive buttons, unexpected restarts, and blank or dim displays. Some mention high or low blood sugar, and most say there was no impact on the patient. 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
- 130
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 00643169202368), received between Jun 5, 2017 and Jul 30, 2020 — classified as 43 injuries, 87 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (32 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 Message32
- Device Difficult to Program or Calibrate16
- Adverse Event Without Identified Device or Use Problem13
- Device Operates Differently Than Expected12
- No Display/Image10
- Mechanical Problem9
- Patient Device Interaction Problem9
- Break8
Patient problems
- No Consequences Or Impact To Patient76
- Hyperglycemia44
- Hypoglycemia12
- Elevated Ketones/ Diabetic Ketoacidosis3
- No Known Impact Or Consequence To Patient2
- Coma1
- Death1
- Dizziness1
Recent adverse event reports
The 25 most recent of 130 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE NOT RESPONDING AND UNEXPECTED RESTART ERROR ALARM. CUSTOMER STATED THAT THE MENU CONTINUES TO SCROLL WITHOUT INPUT BY USER. CUSTOMER WAS UNABLE TO TROUBLESHOOT UNEXPECTED RESTART ERROR TEST BECAUSE THE KEYPAD WAS NOT RESPONDING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10343017 ↗MalfunctionJul 24, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON THE INSULIN PUMP WERE VERY HARD TO PUSH. IT WAS STATED THAT BACKLIGHT ON INSULIN PUMP SCREEN WAS DIM AND CUSTOMER CANNOT REALLY SAW THE SCREEN, CUSTOMER COULD NOT GET BASAL INSULIN PUMP SETTINGS TO COME UP.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 10318783 ↗MalfunctionJul 21, 2020Premature Discharge of Battery; No Display/Image; Premature Discharge of Battery; No Display/Image
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. CUSTOMER STATED THAT INSULIN PUMP ERROR ALARM RECURRED AFTER A BATTERY CHANGE. THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THAT THE DISPLAY RETURNED AFTER INSULIN PUMP RESTART. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10300486 ↗MalfunctionJul 3, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTON ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WAS OBSERVED TIME CLOCK FOR ONE MINUTE TO VERIFY TIME WAS CHANGE. INSULIN PUMP STOPPED SCROLLING AND SHE COULD CHANGE THE TIME AND DATE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10228959 ↗MalfunctionApr 23, 2020Mechanical Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Patient Device Interaction Problem; Priming Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PRIME FILL ANOMALY AND REWIND ANOMALY. THE CUSTOMER STATED THEY WERE UNABLE TO PROPERLY REWIND THE INSULIN PUMP IN ADDITION TO THE PRIME FILL ANOMALY. 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 9992663 ↗MalfunctionMar 16, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT AND INSULIN PUMP HAD SQUIRTED OUT INSULIN. 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 9835260 ↗MalfunctionJan 3, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE AREA BY THE RESERVOIR WAS TAPED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED CRACKS ON THE INSULIN PUMP CASING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9543931 ↗MalfunctionDec 31, 2019Premature Discharge of Battery; Premature Discharge of Battery
CUSTOMER'S DAUGHTER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART, A COLD RESET WAS PERFORMED ALARM AND INSULIN PUMP WAS BEEPING WHEN THEY WERE CHANGING SET UP. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9533974 ↗MalfunctionNov 6, 2019Premature Discharge of Battery; Failure to Cycle; Premature Discharge of Battery; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR ALERT AND UNEXPECTED RESTART ALARM. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THAT THEY WERE NOT ABLE TO CLEAR THE ALARM. CUSTOMER ABLE TO COMPLETE REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9283198 ↗MalfunctionNov 1, 2019Failure to Cycle; No Apparent Adverse Event; Failure to Cycle; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA THAT THE INSULIN PUMP ALARMED FOR COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE FIRSTLY THEY DID NOT GO THROUGH THE REWIND PROCESS. CUSTOMER REPORTED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER WAS ABLE TO CLEAR THE ALARM. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEED 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 9265150 ↗MalfunctionOct 31, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE UP ARROW DOES NOT RESPOND TO PRESSES SOMETIMES AND INSULIN PUMP ALARMED WITH FAILED BATTERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9259502 ↗MalfunctionOct 24, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP¿S BOLUS BUTTON WAS NOT WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 190 MG/DL. CUSTOMER WAS ADVISED THAT THE TIME NEEDED TO BE SET UP AND INSULIN PUMP REWOUND TO PRIME THE TUBING TO CLEAR ALARM AND TURNED SENSOR SETTINGS OFF PER REQUEST AND THEN WAS ABLE TO BOLUS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9232638 ↗InjuryOct 23, 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 LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 47 MG/DL AT THE TIME OF INCIDENT AND 221 MG/DL AT THE TIME OF CALL. CUSTOMER WAS TREATED WITH CANNED COKE. TROUBLESHOOTING WAS DECLINED FOR LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 9222705 ↗MalfunctionOct 9, 2019Failure to Cycle; Power Problem; Failure to Cycle; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP SQUIRTING ALL THE INSULIN OUT OF THE RESERVOIR. 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 NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9171290 ↗MalfunctionSep 26, 2019Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE MENU CONTINUES TO SCROLL AND THE ESC KEY OF THE INSULIN PUMP WAS NOT RESPONDING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER WAS NOT ABLE CLEAR THE ALARMS. CUSTOMER STATED THAT THE INSULIN PUMP WAS BUMPED. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9122944 ↗MalfunctionSep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING UNKNOWN ISSUE WITH THAT UNDER THIS LEGAL HOLD MAY NOT BE DESTRUCTIVELY ANALYZED WITHOUT WRITTEN APPROVAL FROM THE CORPORATE LITIGATION DEPARTMENT. THE INFORMATION WAS RECEIVED ON SEPTEMBER 18, 2019. RESERVOIR, INFUSION SET AND INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9096290 ↗MalfunctionSep 19, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR DURING BOLUS. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 382 MG/DL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATES THE TIME WAS ADVANCES. 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 9085811 ↗MalfunctionAug 27, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER'S FAMILY MEMBER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE NOT FUNCTIONING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE ESC BUTTON WAS STUCK. THE CUSTOMER WAS ALSO 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 DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8934134 ↗MalfunctionAug 23, 2019Priming Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SQUIRTED INSULIN DURING THE MANUAL PRIME PROCESS AND THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 129 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THEY WERE ABOUT TO CHANGE THE INFUSION SET, HOWEVER THE INSULIN PUMP WAS UNABLE TO FINISH FILL TUBING. THE INSULIN CONTINUED TO DRIP AFTER THE MOTOR STOPPED DURING THE MANUAL PRIME PROCESS. THE CUSTOMER MENTIONED THAT THE INSULIN WAS ALREADY OUT AND STILL NOT ABLE TO FINISH THE FILL TUBING PROCESS. THE CUSTOMER STATED THAT THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE CUSTOMER DID NOT RECEIVE 2ND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. 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 8925504 ↗MalfunctionAug 17, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate
CUSTOMER REPORTED VIA PHONE CALL THAT NONE OF THE BUTTONS WAS RESPONDING ON INSULIN PUMP AND RECEIVED UNEXPECTED RESTART ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT TIME ADVANCES DURING THE ISSUE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF INSULIN PUMP. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8904145 ↗MalfunctionAug 15, 2019Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE MOTOR JUST STOPS HALF WAY THROUGH AND THEY HAD TO RESTART IT. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THEY HAD AN ISSUE WITH THE RESERVOIR. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8896133 ↗MalfunctionJul 29, 2019No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem
CUSTOMER'S HUSBAND REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS WORKING SOMETIMES AND SOMETIMES IT WAS NOT. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 160 MG/DL. CUSTOMER STATED THAT INSULIN PUMP'S CASING WAS DAMAGED. THE DEVICE WILL BE RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8835413 ↗InjuryJun 26, 2019Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE CAUSED BY MOTOR ERROR ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 400 MG/DL. CUSTOMER PROVIDES DETAILS REGARDING SYMPTOMS OF THEIR HIGH BLOOD GLUCOSE EPISODES SUCH AS NAUSEA AND VOMITING. THE CUSTOMER TREATED WITH THE INTRAVENOUS DRIP. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER TROUBLESHOOTING WAS PERFORMED FOR MOTOR ERROR AND DID NOT WISH TO PERFORMED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Vomiting
MAUDE report 8733772 ↗InjuryJun 19, 2019Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL AND NO DELIVERY ALARM DURING MANUAL PRIME. THE ISSUE STARTED ON (B)(6) 2018. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS OVER 400 MG/DL WHICH WAS TREATED WITH INSULIN PUMP AND ORAL MEDICATION. CUSTOMER ALSO REPORTED GETTING SKIN IRRITATION FROM THE ADHESIVE OF THE INFUSION SET. CUSTOMER HAD TO SEEK MEDICAL ASSISTANCE ON (B)(6) 2018 TO TREAT INFECTION. CUSTOMER COMPLETED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Unspecified Infection
MAUDE report 8713915 ↗MalfunctionJun 18, 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 109 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTS THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER NOT ABLE TO COMPLETE REWIND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8706759 ↗
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-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Z-1593-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- Z-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- Z-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Z-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- 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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