Paradigm® REAL-Time Revel™ MMT-523RNAB (UDI 00643169221512)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523RNAB PRDGM V2.5B BL EN RH X7 · 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 119 adverse event reports, with 52 injuries and 4 deaths. Many describe incorrect messages on the display, parts breaking, and high or low blood sugar, and some mention difficulty programming. 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
- 119
- Deaths reported
- 4
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 00643169221512), received between Jun 2, 2017 and Apr 2, 2020 — classified as 4 deaths, 52 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (17 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 Problem20
- Device Displays Incorrect Message17
- Patient Device Interaction Problem16
- Break14
- Device Difficult to Program or Calibrate13
- Insufficient Device Problem Information13
- Battery Problem8
- Power Problem5
Patient problems
- No Consequences Or Impact To Patient56
- Hyperglycemia49
- Hypoglycemia16
- Death4
- Cardiac Arrest1
- Dementia1
- Dyspnea1
- Loss of consciousness1
Recent adverse event reports
The 25 most recent of 119 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED FOR LOW BLOOD GLUCOSE ON (B)(6) 2020. BLOOD GLUCOSE LEVEL WAS 46 MG/DL. IT WAS UNKNOWN WHETHER CUSTOMER USING AUTO MODE OR NOT. TROUBLESHOOTING WAS PERFORMED AND BASED ON REPORT THEY DID NOT ALLEGE ON INSULIN PUMP WAS OVER-DELIVERING CUSTOMER WAS TREATED WITH FOOD AND GLUCOSE. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 9914707 ↗MalfunctionMar 30, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY, FAILED BATTERY TEST AND LESS BATTERY LIFE. TROUBLESHOOTING WAS NOT PERFORMED. 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 9896445 ↗InjuryDec 24, 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'S DAUGHTER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 411 MG/DL. CUSTOMER STATED THAT THE INSULIN EXITED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9515983 ↗MalfunctionOct 15, 2019No Display/Image; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; No Display/Image; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 198 MG/DL. CUSTOMER STATED THAT THE CONTACT ON THE BATTERY CAP WAS NEITHER MISSING NOR DAMAGE. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THAT THE SPRING WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THAT THE DISPLAY DID NOT RETURN AFTER INSULIN PUMP RESTART. 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 9189911 ↗MalfunctionOct 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTED VIA PHONE CALL THAT DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT CUSTOMER WAS REWINDING THE INSULIN PUMP WHEN INSULIN PUMP FELL APART, THE WHOLE BOTTOM OF THE PUMP CAME OFF, MOTOR OF THE PUMP WAS OUT. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9159911 ↗MalfunctionOct 3, 2019Premature Discharge of Battery; Premature Discharge of Battery
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 99 MG/DL. CUSTOMER STATED THAT ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER HAD NOT EXPERIENCED MULTIPLE ALARMS AFTER BATTERY CHANGE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9149821 ↗MalfunctionAug 23, 2019Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SCREEN WAS HARD TO READ. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED CURRENT INSULIN PUMP HAD UNEXPECTED NO DELIVERY ALARMS AND HAD WARP EFFECT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8925411 ↗MalfunctionAug 1, 2019Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED PIECE OF INSULIN PUMP MISSING WHERE RESERVOIR ATTACHES, BATTERIES DYING QUICKER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8849574 ↗MalfunctionJul 25, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 240 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT ACT AND ARROW BUTTONS DID NOT WORK. CUSTOMER ALSO REPORT THAT INSULIN PUMP HAD BATTERY OUT LIMIT A COUPLE WITHOUT CHANGING BATTERY. 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 8826962 ↗MalfunctionJul 15, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE CORNER OF THE RESERVOIR COMPARTMENT WAS CHIPPED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8788402 ↗MalfunctionJul 10, 2019Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHED SCREEN AND AFFECT ABILITY TO SEE. 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 8775119 ↗MalfunctionJul 3, 2019Failure to Cycle; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem; Failure to Cycle; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN SQUIRTING DURING PRIMING. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED SCRATCHES ON SCREEN, MOTOR SOUNDS LABORED AND BATTERY LIFE WAS DIMINISHED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8757170 ↗DeathJun 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS DIABETES. THE CALLER STATED THAT THE CUSTOMER HAD NO OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 20 MG/DL AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CUSTOMER WENT INTO A SEIZURE, STOPPED BREATHING AND THE PARAMEDICS COULD NOT RESUSCITATE THEM. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.
Patient problems: Death; Hypoglycemia; Seizures
MAUDE report 8726246 ↗MalfunctionJun 21, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Moisture or Humidity Problem; Premature Discharge of Battery; Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Moisture or Humidity Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE NON OF THE BUTTONS OF THE INSULIN PUMP WERE RESPONDING. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 121 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THEY WERE STUCK IN THE RAIN AND THE INSULIN PUMP GOT WET. THE CUSTOMER LATER CHANGED THE BATTERY DUE TO AN ALERT AND RECEIVED AN UNEXPECTED RESTART ALARM BUT NON OF THE BUTTONS WERE RESPONDING. THE CUSTOMER WAS UNABLE TO PERFORM TROUBLESHOOTING AS THE BUTTONS WERE NOT RESPONDING. 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 8721136 ↗MalfunctionJun 20, 2019Premature Discharge of Battery; Unexpected Shutdown; Premature Discharge of Battery; Unexpected Shutdown
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART ALARMED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 220 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ALSO WAS COMPLETE REWIND. CUSTOMER ALSO STATED THAT THE RECEIVING ANOTHER UNEXPECTED RESTART ALARMED AFTER A BATTERY CHANGE. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8715750 ↗InjuryMay 16, 2019Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 400 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 242 MG/DL. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD NO DELIVERY ALARM BUT ISSUE WAS RESOLVED BY CHANGING SET. INSULIN PUMP WAS BEEPING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8615084 ↗MalfunctionMay 15, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component
THE CUSTOMER'S FAMILY WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 199 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS RECESSED. 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 8610836 ↗MalfunctionMay 14, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHES ON SCREEN MAKE IT HARDER TO READ AND SOME TIME ACT BUTTON PRESS TWICE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD CHANGING BATTERY LESS THAN 7 DAY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8607056 ↗MalfunctionApr 27, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE ACT BUTTON DID NOT ALWAYS RESPOND AS WELL AS INSULIN PUMP WAS CRACKED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8559197 ↗InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 504 MG/DL. THE CUSTOMER WAS TREATED WITH INJECTION. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8498236 ↗InjuryApr 5, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER'S FAMILY MEMBER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 257 MG/DL,448 MG/DL. THE CUSTOMER WAS TREATED WITH BOLUS. CUSTOMER ALSO REPORTED BUTTONS WERE UNRESPONSIVE TROUBLESHOOTING WAS PERFORMED AND KEYPAD RAMPING UNCONTROLLABLY. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8485960 ↗MalfunctionMar 25, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER'S DAUGHTER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 125 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER'S DAUGHTER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO REPLACE AND 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 8447582 ↗MalfunctionMar 7, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE BUTTONS WERE NOT RESPONDING ITS THE DOWN BUTTON IT KEPT STICKING. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8398499 ↗MalfunctionMar 5, 2019Device Difficult to Program or Calibrate; Material Integrity Problem; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTONS HARD TO PRESSED. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER REPORTS THAT BATTERY CAP WAS CRACKED HOLDING WITH DUCK TAPE AND DIMINISHED BATTERY LIFE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8392341 ↗MalfunctionMar 5, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A BUTTON ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 60 MG/DL AT THE TIME OF INCIDENT AND TREATED WITH FOOD. CUSTOMER STATED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. 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: Hypoglycemia
MAUDE report 8390573 ↗
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-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- 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-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-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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