Paradigm® REAL-Time Revel™ MMT-523NAS (UDI 00643169202344)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523NAS PRDGM INS V2.5 SK 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 MiniMed Paradigm REAL-Time Revel insulin pump has 292 reports, including 101 injuries and 1 death. Some describe incorrect messages or unresponsive buttons, and many patients mention high blood sugar. 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
- 292
- Deaths reported
- 1
- Injuries reported
- 101
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 292 adverse event reports that list this exact device (DI 00643169202344), received between May 11, 2017 and Sep 29, 2020 — classified as 1 death, 101 injuries, 190 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (60 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 Message60
- Patient Device Interaction Problem48
- Device Difficult to Program or Calibrate33
- Adverse Event Without Identified Device or Use Problem29
- Mechanical Problem21
- No Display/Image21
- Power Problem17
- Premature Discharge of Battery17
Patient problems
- No Consequences Or Impact To Patient175
- Hyperglycemia95
- Hypoglycemia19
- No Known Impact Or Consequence To Patient6
- Fatigue5
- Irritation3
- Elevated Ketones/ Diabetic Ketoacidosis2
- Skin Irritation2
Recent adverse event reports
The 25 most recent of 292 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RESERVOIR RING WAS BROKEN AND ALSO RECEIVED NO DELIVERY ALARM. CUSTOMER STATED THERE WAS PHYSICAL DAMAGE TO RETAINER RING AND RESERVOIR WAS ABLE TO LOCK IN PLACE. IT WAS REPORTED THAT INSULIN DID NOT EXIT AND INSULIN PUMP ALARMED NO DELIVERY DURING FIXED PRIME. DURING MANUAL PRIME CUSTOMER OBSERVED THAT INSULIN WAS EXITED TUBING. 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 10598840 ↗MalfunctionAug 12, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. CUSTOMER WAS ABLE TO CLEAR ALARM AND REWIND PROCESS. CUSTOMER STATED THAT INSULIN PUMP HAD CRACK AT RESERVOIR COMPARTMENT AND BATTERY COMPARTMENT. RESERVOIR WAS ABLE TO LOCK INTO PLACE WHEN INSERTED INTO INSULIN PUMP. 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 10394983 ↗MalfunctionJul 30, 2020Use of Device Problem; Use of Device Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD RESET THE SETTINGS WITH BATTERY CHANGES. CUSTOMER DECLINED TO PROVIDE BLOOD GLUCOSE LEVEL. 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 10343008 ↗MalfunctionJul 25, 2020Computer Software Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Computer Software Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER STATED THAT, THE BUTTONS WERE NO LONER WORKING AND THERE WERE CRACK AT THE BATTERY AREA AND THE INSULIN PUMP SCREEN WAS CHIPPED OUT. 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 10324243 ↗InjuryJun 30, 2020Device Difficult to Program or Calibrate; Moisture or Humidity Problem; No Apparent Adverse Event; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS MORE THAN 500 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE BUTTONS ON HIS INSULIN PUMP WERE NOT WORKING. CUSTOMER STATED THAT HE RECEIVED A BUTTON ERROR ALARM. CUSTOMER STATED THAT HE CHANGED OUT THE INFUSION SETS AND HIS BLOOD GLUCOSE WENT DOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 10210958 ↗MalfunctionJun 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS BROKEN OFF AND STOPPED WORKING. THE CAP WAS STICKING OUT. 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 10178036 ↗MalfunctionJun 18, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTON WAS STUCK AND WAS NOT WORKING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10166641 ↗MalfunctionJun 18, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ESC,ACT BUTTONS OF INSULIN PUMP WERE UNRESPONSIVE. IT WAS REPORTED THAT THE TIME CLOCK WAS ADVANCING. CUSTOMER STATED THAT THE EYE SITE WAS BLURRY. 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 10166176 ↗MalfunctionJun 2, 2020Failure to Cycle; Failure to Cycle
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. 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 10107686 ↗MalfunctionMay 12, 2020Obstruction of Flow; Obstruction of Flow
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON THE INSULIN PUMP WERE LESS RESPONSIVE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT THE TIME WAS ADVANCING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10048226 ↗MalfunctionMay 11, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ESCAPE KEY STOPPED WORKING. CUSTOMER STATED THAT THEY WERE UNSURE ABOUT TIME WAS ADVANCING OR NOT. 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 10042298 ↗MalfunctionApr 28, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HYPOGLYCEMIA WITH BLOOD GLUCOSE LEVEL OF 46 MG/DL. CUSTOMER WAS DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED WITH MILK FOR LOW BLOOD GLUCOSE LEVEL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 10006055 ↗MalfunctionApr 14, 2020Failure to Cycle; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Failure to Cycle; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED UNEXPLAINED NO DELIVERY ALARM, MOTOR ERROR,INSULIN PUMP ERROR, DIMINISHED BATTERY LIFE, RESERVOIR RING WAS CRACK AS WELL AS BUTTON WAS STICKY. 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 9956690 ↗MalfunctionMar 25, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE INSULIN PUMP HAD PHYSICAL DAMAGE. CUSTOMER BLOOD GLUCOSE WAS UNKNOWN AT TIME OF THE EVENT. CUSTOMER WAS ADVISED A REPLACEMENT WILL BE SENT. INSULIN PUMP IS EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9880881 ↗MalfunctionMar 19, 2020Device Alarm System; Battery Problem; Patient Device Interaction Problem; Device Alarm System; Battery Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SOMETIME IT JUST WAS EMPTY WITH NO WARNINGS. THE CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED UNEXPLAINED NO DELIVERY ALARMS, DOES NOT GIVE LOW RESERVOIR WARNINGS AND BATTERY SCRATCHES ON SCREEN. 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 9852035 ↗MalfunctionJan 28, 2020Mechanical Problem; Environmental Compatibility Problem; Patient Device Interaction Problem; Mechanical Problem; Environmental Compatibility Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP MOTOR ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR EXPOSITION ENCODER ALARM. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MAGNETIC RESONANCE IMAGE. CUSTOMER WAS NOT ABLE TO CLEAR ALARM. CUSTOMER STATED THAT BATTERY CAP WAS BROKEN. THE INSULIN PUMP WAS TURNED OFF. CUSTOMER STATED THAT THE INSULIN PUMP HAD BURNED SIDE AND BROKEN BATTERY THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 9635715 ↗MalfunctionJan 14, 2020Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CRACK ON THE BATTERY COMPARTMENT, MOTOR ERRORS AND RANDOM UNEXPLAINED NO DELIVERY ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9585568 ↗MalfunctionJan 7, 2020Device Difficult to Program or Calibrate; No Apparent Adverse Event; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 314 MG/DL. CUSTOMER REPORTED THAT THE ACT BUTTON AND OTHER KEYS WERE NOT WORKING. MOISTURE CAME OUT OF THE ACT KEY. 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 DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9557295 ↗MalfunctionDec 31, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD KEYPAD ANOMALY AND UP ARROW BUTTON WAS NOT WORKING. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT TIME ADVANCES DURING THE KEYPAD ISSUE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO 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 9535193 ↗MalfunctionDec 20, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED UNEXPECTED RESTART ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THEY HE WOKE UP TO THE ALARM ON THE INSULIN PUMP, CUSTOMER TOOK THE BATTERY OUT AND THE INSULIN PUMP CONTINUES TO GO THROUGH RESET AND THE ACT AND ESCAPE BUTTONS WAS NOT WORKING. CUSTOMER REPORTED THAT THEY WAS UNABLE TO CLEAR THE ALARM. CUSTOMER WAS TRYING TO GIVE THE INSULIN PUMP A COMMAND AND THE BUTTONS WOULD NOT RESPOND. CUSTOMER WAS OBSERVE TIME CLOCK FOR ONE MINUTE AND TIME WAS ADVANCES. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE 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 9502351 ↗MalfunctionDec 19, 2019Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT CRACK NEAR THE RESERVOIR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT BATTERIES ARE DRAINING OUT QUICKLY AND INSULIN PUMP HAD NO DELIVERY MESSAGES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9493033 ↗MalfunctionDec 9, 2019Device Alarm System; Mechanical Problem; Date/Time-Related Software Problem; Power Problem; Patient Device Interaction Problem; Priming Problem; Device Alarm System; Mechanical Problem; Date/Time-Related Software Problem; Power Problem; Patient Device Interaction Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN SQUIRTS WHEN PRIMING AND CLOCK DID NOT KEPT TIME. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD REJECTING NEW BATTERIES AND REWIND WAS LOUDER AND SCREEN WAS DIM AND HARD TO SEE. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND ALARM NOT AS LOUD AND CRACK BY RESERVOIR AND RIM AROUND INSULIN PUMP WAS BROKEN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9442795 ↗MalfunctionDec 2, 2019Device Alarm System; No Display/Image; Power Problem; Device Alarm System; No Display/Image; Power Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK SCREEN AND ALSO HAD ISSUE WITH HEARING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD BATTERY OUT LIMIT AND IT CONTINUED WITH EACH BATTERY AND THEY DID NOT CLEAR THE BATTERY OUT LIMIT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9399522 ↗MalfunctionNov 28, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate
THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED ALARM AS WELL AS BUTTON ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER REPORTED THAT THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER STATED HITS THE ESCAPE BUTTON AND REROUTING TO UP BUTTON. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT TIME WAS WRONG. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED 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: No Consequences Or Impact To Patient
MAUDE report 9388269 ↗MalfunctionNov 25, 2019Premature Discharge of Battery; Premature Discharge of Battery
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM, ABLE TO COMPLETE REWIND. CUSTOMER REMOVE THE CURRENT BATTERY FROM THE INSULIN PUMP AND INSERT A NEW BATTERY THEN INSULIN PUMP ALARMED MULTIPLE UNEXPECTED RESTART. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9373783 ↗
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-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Z-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- 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-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
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- 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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