Paradigm® REAL-Time Revel™ MMT-523RNAS (UDI 00613994918611)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523RNAS PRDGM INS V2.4 SK EN RC · Class 3
All models of Paradigm REAL-Time Revel (180)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These reports describe this Medtronic Paradigm Revel insulin pump: buttons needing repeated presses, motor errors, blank screens, missing delivery alerts, and battery trouble, sometimes with high or low blood sugar. There are 26 adverse event reports, with 3 deaths and 11 injuries. 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
- 26
- Deaths reported
- 3
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00613994918611), received between Jun 22, 2017 and Jul 15, 2020 — classified as 3 deaths, 11 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (4 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 Problem5
- Device Difficult to Program or Calibrate4
- Patient Device Interaction Problem4
- Mechanical Problem3
- No Display/Image3
- Obstruction of Flow3
- Battery Problem2
- Device Displays Incorrect Message2
Patient problems
- No Consequences Or Impact To Patient12
- Hyperglycemia9
- Death3
- Hypoglycemia3
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS HAD TO BE PRESSED MORE THAN ONCE. CUSTOMER STATED INSULIN PUMP BATTERY LIFE WAS SOMETIMES HAD ISSUE AND NO DELIVERY ALERTS. 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 10274951 ↗InjuryFeb 10, 2020Mechanical Problem; Obstruction of Flow; Environmental Compatibility Problem; No Apparent Adverse Event; Mechanical Problem; Obstruction of Flow; Environmental Compatibility Problem; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT INSULIN PUMP WAS EXPOSED TO COMPUTE TOMOGRAPHY SCAN. CUSTOMER STATED THAT THEY RECEIVED NO DELIVERY ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9686564 ↗MalfunctionFeb 4, 2020Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATE THAT THE BOTTOM PART OF INSULIN PUMP WAS FALLING APART. CUSTOMER REPORTED DAMAGED TO THE DRIVE SUPPORT CAP. 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 9663242 ↗MalfunctionNov 28, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER'S HUSBAND REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARM WENT OFF WITH AN BUTTON ERROR ON THE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. THE CUSTOMER ALSO REPORTED TIME WAS ADVANCING. 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 9389343 ↗MalfunctionAug 1, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN AND THE SCREEN WAS HARDER TO READ. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD RANDOM NO DELIVERY ALARM AND INSULIN PUMP WAS LOUDER DURING REWIND. THE CUSTOMER ALSO STATED THAT THEY NEED TO REPLACING THE BATTERIES UNDER SEVEN DAYS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8849856 ↗InjuryJun 24, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 230 MG/DL. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROFESSIONAL¿S INSTRUCTION. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8725899 ↗MalfunctionApr 20, 2019No Display/Image; No Display/Image
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY AND UNEXPECTED RESTART ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DISPLAY DID RETURNED BACK. 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 8534091 ↗MalfunctionApr 18, 2019Mechanical Problem; Priming Problem; Mechanical Problem; Priming Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS REWIND MORE THAN ONCE DURING PRIMING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THERE WAS POLARIZATION ON SCREEN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8526478 ↗InjuryFeb 1, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL TO 400 MG/DL. THE CUSTOMER WAS TREATED WITH BOLUS, MANUAL INJECTION. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8299408 ↗MalfunctionNov 14, 2018No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR COMPARTMENT WAS DAMAGED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. 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 8068273 ↗DeathNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME IN HOSPICE CARE. THE CAUSE OF DEATH WAS LUNG CANCER. THE CALLER STATED THAT THE CUSTOMER HAD C.O.P.D THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 650 MG/DL AT THE TIME OF ADMISSION INTO HOME HOSPICE CARE. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS AS THEY NO LONGER HAD IT.
Patient problems: Death; Hyperglycemia
MAUDE report 8068138 ↗DeathOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2017. THE CAUSE OF DEATH WAS UNKNOWN AS NO AUTOPSY WAS PERFORMED. THE CALLER STATED THAT THE CUSTOMER HAD HEART ISSUES, DIABETES, AND KIDNEY ISSUES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS. FRN-UNK-RSVR. UNOMED SET.
Patient problems: Death
MAUDE report 7942092 ↗MalfunctionAug 24, 2018Premature Discharge of Battery; Premature Discharge of Battery
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE BLOOD GLUCOSE LEVEL WAS 119 MG/DL. THE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED THAT THE ALARM WAS OCCURRED AFTER A BATTERY CHANGE. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO MONITOR THE PUMP AND THAT PATIENT MAY CONTINUE TO WEAR THE PUMP UNTIL A REPLACEMENT ARRIVES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7812160 ↗MalfunctionJul 25, 2018Failure 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 130 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 7717446 ↗MalfunctionJul 16, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 168 MG/DL. THE INSULIN PUMP WAS EXPOSED TO MOISTURE AND HAD A BLANK DISPLAY. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7688967 ↗InjuryMay 18, 2018No Display/Image; Device Inoperable
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PUMP WAS NOT WORKING AND HAD A BLANK DISPLAY. CUSTOMER TREATED HERSELF WITH MANUAL INJECTION. TROUBLESHOOTING WAS DECLINED FOR HIGH BLOOD GLUCOSE AND ALSO DISPLAY DID NOT RETURNED. THE PRODUCT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7525065 ↗InjuryFeb 20, 2018Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE VALUE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS OVER 400MG/DL AND 405MG/DL AT THE TIME OF INCIDENT. CUSTOMER TREATED WITH INSULIN PUMP. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE VALUE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7282481 ↗InjuryJan 16, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 500 MG/DL. NO DELIVERY ALARM WAS ALSO REPORTED. TROUBLESHOOTING WAS DECLINED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7195422 ↗InjuryOct 18, 2017Insufficient Device Problem Information
CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE VALUE. CUSTOMER'S BLOOD GLUCOSE VALUE LAST WEEK WAS 400MG/DL. CUSTOMER BLOUSED FOR THAT AND WHEN SHE WOKE UP IT WAS OVER 600MG/DL SO SHE BLOUSED AGAIN BUT BLOOD GLUCOSE LEVEL DID NOT COME DOWN. CUSTOMER CHANGED QUICK SET AND WITHIN AN HOUR BLOOD GLUCOSE VALUE WAS DOWN TO 400MG/DL SOMETHING THEN OVER ABOUT 3 HOURS IT WAS DOWN TO THE RANGE OF 200MG/DL. CUSTOMER TREATED WITH THE PUMP AND BLOOD GLUCOSE CAME DOWN TO 179MNG/DL. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6960281 ↗InjuryOct 17, 2017Adverse Event Without Identified Device or Use Problem
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE AND GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 22 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN KARO SYRUP TO TREAT. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP DURING THE INCIDENT, WITHIN LESS THAN 48 HOURS. THE CUSTOMER SUFFERED SOME BRAIN DAMAGE AFTER THE LOW INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE CUSTOMER REPORTED THAT THE PUMP HAD PHYSICAL DAMAGE ON THE BATTERY COMPARTMENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 6955998 ↗DeathAug 23, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CUSTOMER WAS NOT HOSPITALIZED. THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE DUE TO COMPLICATIONS OF DIABETES. THE CALLER STATED THAT THE CUSTOMER HAD KIDNEY FAILURE AND HEART DISEASE THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.
Patient problems: Death
MAUDE report 6813713 ↗InjuryJul 20, 2017Bent
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR BLOOD GLUCOSE EXCEEDED 400 MG/DL FOR HOURS. THE CUSTOMER TREATED VIA INSULIN PUMP THERAPY AND MANUAL INSULIN INJECTION. HOWEVER, AFTER EATING DINNER AND INJECTING INSULIN, HER BLOOD GLUCOSE INCREASED TO NEARLY 400 MG/DL. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 427 MG/DL. SHE EXPERIENCED NAUSEA AND ABDOMINAL PAIN. DURING TROUBLESHOOTING THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER NOTED THAT HER INFUSION SET CANNULA WAS BENT. THE CUSTOMER WAS ADVISED TO CHANGE HER INFUSION SET, RESERVOIR AND INSULIN AND TO RESUME TREATMENT. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6730266 ↗InjuryJul 11, 2017Device Displays Incorrect Message
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS OF 52 MG/DL. THE CUSTOMER HAD SYMPTOMS SUCH AS SLEEPING AND WAS PERSPIRING FROM HER LOW BLOOD GLUCOSE. THE CUSTOMER WAS TREATED FOR THE LOW BLOOD GLUCOSE WITH JUICE. THE CUSTOMER STATED THE INSULIN PUMP ALARMED BUTTON ERROR. ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES; FOUND THE TIME ADVANCES. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 6703587 ↗MalfunctionJul 11, 2017No Display/Image
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAS A PARTIAL DISPLAY BEFORE AND AFTER A BATTERY CHANGE. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING BUT THE DISPLAY ONLY HAS TINY LINES ON THE SCREEN. THE PRODUCT WILL NOT BE RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6703033 ↗InjuryJul 6, 2017Break; Material Disintegration
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE RESERVOIR COMPARTMENT HAS BEEN CHIPPING OFF AND THAT LAST NIGHT A BIG PIECE CAME OFF AND NOW CUSTOMER CANNOT GET RESERVOIR TO STAY IN THE PUMP. CUSTOMER HAS REVERTED TO ANOTHER PUMP BLOOD GLUCOSE WAS 570 MG/DL, THE CUSTOMER USED OTHER PUMP TO BOLUS BLOOD GLUCOSE WAS 549 MG/DL. 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: Hyperglycemia
MAUDE report 6689395 ↗
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-1749-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Insulin Pump (MMT-522, MMT-722)
- Z-1750-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
- 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-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- 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-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- 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-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- 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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