Paradigm® REAL-Time Revel™ MMT-523NAB (UDI 00643169202306)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523NAB PRDGM INS V2.5 BL 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 is a Medtronic MiniMed Paradigm REAL-Time Revel insulin pump. Most of the 53 reports describe the pump misbehaving in everyday ways: error messages on the screen, buttons that stop responding, battery or power trouble, cracked housings and screens, and insulin being squirted out instead of dripped, sometimes with no delivery alarm. The reports involve 24 injuries and no deaths, with high blood sugar the most common patient problem. 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
- 53
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00643169202306), received between Jun 7, 2017 and Jul 21, 2020 — classified as 24 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (11 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 Message11
- Adverse Event Without Identified Device or Use Problem8
- Device Difficult to Program or Calibrate5
- Mechanical Problem4
- No Display/Image4
- Patient Device Interaction Problem4
- Power Problem4
- Device Alarm System3
Patient problems
- No Consequences Or Impact To Patient25
- Hyperglycemia24
- Hypoglycemia4
- Elevated Ketones/ Diabetic Ketoacidosis1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2020Mechanical Problem; Obstruction of Flow; Material Integrity Problem; Mechanical Problem; Obstruction of Flow; Material Integrity Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT SOMETIMES INSULIN WAS SQUIRTED RATHER THAN DRIPS. INSULIN PUMP RECEIVED NO DELIVERY ALARMS. REWIND WAS LOUDER AND SLOWER. 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 10300386 ↗MalfunctionJul 7, 2020Device Alarm System; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem; Device Alarm System; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD LOCKED UP AND BECOME NON RESPONSIVE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE INSULIN PUMP HAD CRACKED ON BATTERY ARE AS WELL AS SCREEN AND BATTERY LIFE WAS DECREASED FROM FIRST DAY AND SLOWER TO REWIND. INSULIN PUMP RECEIVED UNEXPLAINED RANDOM NO DELIVERY ALARM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10238724 ↗InjuryJan 15, 2020Adverse 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 MOTHER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HYPERGLYCEMIA FROM (B)(6) 2019 TILL (B)(6) 2019. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS OVER 500 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED TWO INFUSION SETS THAT HAD BENT CANNULAS. CUSTOMER¿S MOTHER WAS NOT SURE IF THE INSULIN PUMP WAS INVOLVED OR NOT BECAUSE CUSTOMER HAD A COLD AT THE TIME OF THE INCIDENT. CUSTOMER HAD BEEN SICK. CUSTOMER WAS TREATED AT THE HOSPITAL WITH SALINE AND INSULIN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 9590408 ↗MalfunctionJan 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTED VIA PHONE CALL THAT DRIVE SUPPORT CAP OF INSULIN PUMP WAS PROTRUDED AND LIFTING UP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9551710 ↗MalfunctionJan 6, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 9551427 ↗InjuryNov 13, 2019Adverse 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 DUE TO HYPERGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THEY WERE TRIED TO RESET PASSWORD BUT ARE HAD ISSUES. CUSTOMER WAS INFORMED THAT TICKET WAS SUBMITTED TO HAD THE ACCOUNT REVIEWED AND SHOULD BE RESOLVED WITHIN 48 TO 72 HOURS, SHE UNDERSTOOD AND NO FURTHER ASSISTANCE NEEDED AT TIME OF CALL. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9313980 ↗MalfunctionOct 31, 2019Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CRACKS AND SCRATCHES ON THE SCREEN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS KNOWN. THE CUSTOMER ALSO STATED THAT INSULIN PUMP HAD RANDOM NO DELIVERY ALARMS. THE INSULIN WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9261370 ↗MalfunctionAug 23, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE NOT RESPONDING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. CUSTOMER REPORTED THAT ESC, ACT AND BOLUS BUTTONS WERE NOT RESPONDING. 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 8924148 ↗MalfunctionAug 22, 2019Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 168 MG/DL AT THE TIME OF INCIDENT. 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 8919603 ↗InjuryAug 11, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 425 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE BATTERY CAP WAS BROKEN. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER DID NOT MENTION ANY SYMPTOM RELATED TO HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8882016 ↗MalfunctionAug 6, 2019No Display/Image; Power Problem; No Display/Image; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS SHUT DOWN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT CONTACT ON THE BATTERY CAP WAS NOT MISSING OR DAMAGED. THE CUSTOMER ALSO STATED THAT THERE WAS FAILED BATTERY TEST. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8863590 ↗MalfunctionJul 1, 2019Device 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 147 MG/DL. THE BUTTONS WERE UNRESPONSIVE. 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 8747663 ↗MalfunctionMar 3, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD PUMP ERROR AND DISPLAYABLE HISTORY CRC CHECK FAILED ON STARTUP. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8385024 ↗MalfunctionFeb 18, 2019No Display/Image; Power Problem; No Display/Image; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS RANDOMLY SHUT OFF. THE CUSTOMER¿S BLOOD GLUCOSE WAS 155 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORT THE FAILED BATTERY TEST ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8348958 ↗MalfunctionFeb 15, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME ADVANCES. 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 8345615 ↗MalfunctionJan 14, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CRACK AND PIECE MISSING ON THE BATTERY COMPARTMENT. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8246745 ↗InjuryJan 14, 2019Premature Discharge of Battery; Power Problem; Unexpected Shutdown; Premature Discharge of Battery; Power Problem; Unexpected Shutdown
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 600 MG/DL. THE CUSTOMER DID NOT MENTION ANY TREATMENT FOR HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER DID NOT MENTION ANY SYMPTOM RELATED TO HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER ALSO REPORTED THAT THEY THE INSULIN PUMP RECEIVED THE CLOCK MONITOR TEST DETECTED A MISMATCH BETWEEN THE SYSTEM CLOCK AND THE WATCHDOG CLOCK ERROR AND UNEXPECTED RESTART ALARMS. THE CUSTOMER REPORTED THAT THERE WERE NO ALARMS ON THE INSULIN PUMP TO CLEAR AND WAS ALARM FREE AT THE TIME OF THE CALL. THE CUSTOMER WAS ABLE TO COMPLETE REWIND ON THE INSULIN PUMP. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME AND THE ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE CUSTOMER WAS ADVISED TO REMOVE THE CURRENT BATTERY FROM THE INSULIN PUMP AND INSERT A NEW BATTERY AND THE INSULIN PUMP ALARMED UNEXPECTED RESTART. 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 BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8243533 ↗MalfunctionJan 3, 2019Priming Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER ALSO STATES THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE CUSTOMER¿S BLOOD GLUCOSE WAS 86 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN 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 8211494 ↗MalfunctionOct 15, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAS A CRACK ON THE RESERVOIR COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTION. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7968071 ↗InjurySep 26, 2018Mechanical Problem; Mechanical Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 426 MG/DL. INSULIN PUMP HAD MOTOR ERROR ALARM. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO REWIND. INSULIN PUMP HAD NO DELIVERY ALARM AND IT WAS RESOLVED BY CHANGING COMPLETE SET. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7909032 ↗MalfunctionSep 12, 2018Device Alarm System; Device Alarm System
CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD FAILED BATTERY TEST ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 107 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. THE INSULIN PUMP HAD CONSTANT TONE AND VIBRATING WITHOUT ALERT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7867478 ↗MalfunctionAug 28, 2018Device 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 ALSO STATED THAT THEY HAD BUTTON ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 215 MG/DL. THE CUSTOMER STATED THAT PUMP GOT DISPLAYABLE HISTORY CRC CHECK FAILED ON STARTUP. TROUBLESHOOTING WAS DONE FOR KEYPAD ANOMALY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7821668 ↗InjuryJul 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT HER DAUGHTER EXPERIENCED LOW BLOOD GLUCOSE AND INSULIN PUMP DRIVE SUPPORT CAP ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 34 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS LOOSE CRACKED. THE CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. 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: Hypoglycemia
MAUDE report 7678243 ↗MalfunctionJul 4, 2018Human-Device Interface Problem; Human-Device Interface Problem
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BOTTOM OF PUMP WHERE THE DRIVE SUPPORT CAP . CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7662271 ↗InjuryJun 12, 2018Break; Loss of Power
IT WAS REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP KEPT TURNING OFF AND HAD TO REPLACE THE BATTERY FREQUENTLY. IT WAS ALSO STATED THERE WAS A BROKEN PIECE AT THE RESERVOIR COMPARTMENT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 411 MG/DL AT THE TIME OF THE INCIDENT, CAME DOWN TO 312 MG/DL AND 175 MG/DL AFTER THE CORRECTION. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7592609 ↗
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-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- 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-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- 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-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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