Paradigm® REAL-Time Revel™ MMT-523NAL (UDI 00643169077669)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523NAL PRDGM INS V2.4 CL EN PR · Class 3
All models of Paradigm REAL-Time Revel (180)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic MiniMed Paradigm Revel insulin pump. The 42 reports mostly describe the pump showing wrong messages, unexpected restarts and alarms, buttons sticking, battery test failures, and cracked housings, along with high or low blood sugar readings. Ten reports describe injuries and none describe 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
- 42
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00643169077669), received between Jun 2, 2017 and Aug 6, 2020 — classified as 10 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (12 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 Message12
- Failure to Cycle6
- Device Difficult to Program or Calibrate5
- Patient Device Interaction Problem5
- Adverse Event Without Identified Device or Use Problem4
- Battery Problem3
- Device Operates Differently Than Expected3
- No Apparent Adverse Event3
Patient problems
- No Consequences Or Impact To Patient30
- Hyperglycemia9
- Hypoglycemia6
- Elevated Ketones/ Diabetic Ketoacidosis1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP AN ERROR ON THE BUTTON. CUSTOMER STATED THAT TIME CLOCK WAS ADVANCING. 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 10371719 ↗MalfunctionJul 6, 2020Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER REPORTED SHE EXPERIENCED OPEN CIRCLE ON HER INSULIN PUMP AND AFTER SHE CHANGED THE BATTERY SHE RECEIVED INSULIN PUMP 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 10232468 ↗MalfunctionJun 12, 2020Premature Discharge of Battery; Patient Device Interaction Problem; Premature Discharge of Battery; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK AND RECEIVED UNEXPECTED RESTART 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 10147361 ↗MalfunctionMay 1, 2020Failure to Cycle; Failure to Cycle
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. 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 10018075 ↗MalfunctionApr 28, 2020Failure to Cycle; Failure to Cycle
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. 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 10008008 ↗MalfunctionMar 18, 2020Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE DOWN ARROW OR THE BACKLIGHT BUTTON WERE STICKING UPON BEING PRESSED. THE INSULIN PUMP WAS EXPOSED TO MOISTURE, COMPROMISING THE INTEGRITY OF ITS FUNCTIONS. 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 9846813 ↗MalfunctionMar 5, 2020Failure to Cycle; Battery Problem; Power Problem; Patient Device Interaction Problem; Failure to Cycle; Battery Problem; Power Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SQUIRTING THE INSULIN DURING PRIMING. CUSTOMER STATED THAT THE INSULIN PUMP HAD A FAILED BATTERY TEST EVEN AFTER CHANGING WITH THE FRESH ROOM TEMPERATURE BATTERY. CUSTOMER ALSO STATED THAT THE HAIRLINE FRACTURE WAS OCCURRED IN THE RIGHT TOP CORNER OF THE PLASTIC BODY. 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 9791734 ↗InjuryFeb 10, 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 EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 34 MG/DL TODAY AND 40 MG/DL YESTERDAY. THE CUSTOMER WAS DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 9685867 ↗MalfunctionJan 16, 2020Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING PRIME. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. 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 9595105 ↗MalfunctionJan 6, 2020Premature Discharge of Battery; Premature Discharge of Battery
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE BLOOD GLUCOSE OF THE CUSTOMER WAS UNKNOWN. THE TROUBLESHOOTING WAS PERFORMED AND THEY WERE ABLE TO CLEAR THE ALARM AND COMPLETE THE INSULIN PUMP REWIND. THE CUSTOMER REPORTED THAT THE ALARM OCCURRED AFTER INSERTING THE NEW BATTERY. THE CUSTOMER ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9551380 ↗MalfunctionDec 30, 2019Mechanical Problem; Environmental Compatibility Problem; Mechanical Problem; Environmental Compatibility Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM WHEN PRIMING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER STATED THAT INSULIN PUMP WAS EXPOSED TO HIGH MAGNETIC FIELD AT THE AIRPORT SECURITY. 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 9529603 ↗MalfunctionDec 12, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND INSULIN WAS ALSO COMING OUT DURING PRIME. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 163 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 9456880 ↗MalfunctionNov 20, 2019Device Alarm System; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Moisture or Humidity Problem; Power Problem; Patient Device Interaction Problem; Priming Problem; Device Alarm System; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Moisture or Humidity Problem; Power Problem; Patient Device Interaction Problem; Priming Problem
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTON ERROR AND INSULIN WAS SHOOT OUT WHILE PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT BATTERY CAP AND TOP RIGHT OF SCREEN WAS CRACKED AND REJECTED NEW BATTERIES. CUSTOMER REPORTED THAT INSULIN PUMP HAD NO DELIVERY ALARM, QUICK BOLUS BUTTON DID NOT WORK AND VIBRATE FUNCTION DID NOT WORK, BECOME NON RESPONSIVE DUE TO MOISTURE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9346699 ↗MalfunctionSep 30, 2019Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCED SENSOR ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. THE INSULIN PUMP AND REVERT TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9133156 ↗InjurySep 18, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS ON UNKNOWN WITH BLOOD GLUCOSE OF 232 MG/DL CURRENT BLOOD GLUCOSE. CUSTOMER TREATED WITH INSULIN SHOTS. CUSTOMER STATED CRACKED ON BATTERY COMPARTMENT. 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: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 9080236 ↗MalfunctionJul 18, 2019No Apparent Adverse Event; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD PROBLEM WITH HER OLD INSULIN PUMP AND MISPLACED HER NEW INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 201 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8801799 ↗MalfunctionMay 31, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR PISTON ENCODER ERROR AND MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUED 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 8657272 ↗MalfunctionMay 17, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTON HAS BEEN PRESSED MORE THAN THREE MINUTES AND TO PUSH ESCAPE AND ACT AND NOT DOING ANYTHING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 311 MG/DL AT THE TIME OF THE INCIDENT. 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 8619025 ↗MalfunctionJan 22, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A PARTIAL DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE SCREEN GOES BLACK AND BLACK STRIP APPEAR ON SCREEN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DISPLAY DID NOT RETURNED BACK. THE CUSTOMER WAS ADVISED TO REPLACED 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 8266134 ↗MalfunctionOct 29, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD UNSPECIFIED PUMP ERROR ALARM.. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8013121 ↗InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 35 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 600 MG/DL AFTER BEING TREATED FOR THE LOW. THE CUSTOMER WAS GIVEN DEXTROSE TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 7825153 ↗InjuryAug 1, 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 OF 400MG/DL AT 6PM AND THEN IT WENT LOW AND HOUR LATER TO 45MG/DL. PATIENT TREATED LOW BG WITH FOOD AND HIGH BG WITH BOLUS. NEVER HAS HAD ANYTHING HAPPEN LIKE THIS BEFORE. CUSTOMER DECLINED TO CHECK FOR THE PRESENCE OF LEAKS OR AIR BUBBLES IN THE TUBING OR RESERVOIR OR CHECK SETTINGS OR PROGRAMMING OF PUMP. ADVISED TO MONITOR PUMP AND CALL BACK IF CHANGES OCCUR. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 7738323 ↗MalfunctionJul 20, 2018Crack
THE CUSTOMER REPORTED VIA PHONE CALL THAT RESERVOIR COMPARTMENT WAS CRACKED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. CUSTOMER STATED THAT CUSTOMER HAS COSMETIC DAMAGE THE RESERVOIR IS NOT HOLDING THE RESERVOIRS, PUMP IS OUT OF WARRANTY. CUSTOMER STATES THAT PUMP WAS LOW, WAS CHANGING THE RESERVOIR AND NOTICED A CRACK. HAS TO TAPE THE RESERVOIR IN PLACE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT RESERVOIR COMPARTMENT AND ON CORNERS WAS CRACKED. 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 7705706 ↗MalfunctionMar 9, 2018Device Displays Incorrect Message; Battery Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RECEIVED A FAILED BATTERY ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 190 MG/DL. THE CUSTOMER STATES THEY PUT IN A NEW BATTERY THEY STILL KEEP GETTING FAILED BATTERY TEST. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND NOTICED FAIL BATTERY ALARM RECURRED. ADVISED THE PUMP WILL NEED TO BE REPLACED. 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 7326443 ↗InjuryFeb 28, 2018Device Displays Incorrect Message
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 530 MG/DL. THE CUSTOMER REPORTED THAT THEY DELIVERED TO BOLUS AND HE GOT NO DELIVERY ALARM. TROUBLESHOOT WAS PERFORMED. CUSTOMER REPORTS ALARM 5.0 UNIT FIXED PRIME. CUSTOMER STATES THE INSULIN EXITED. CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD LEVEL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7305180 ↗
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-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Z-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Z-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Z-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- 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-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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page