Paradigm® REAL-Time Revel™ MMT-523LNAH (UDI 00643169932951)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523LNAH PRDGM 3.0 PK EN LN · 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. The 32 reports mostly describe the pump being hard to program, buttons sticking or cracking, unexpected restarts, batteries draining early, and a cracked reservoir ring, along with blood sugar running high or low. There were13 injuries and no 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
- 32
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00643169932951), received between Jan 18, 2018 and Jul 27, 2020 — classified as 13 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (7 reports).
14 other recalls cover devices cleared under the same FDA submission (P150019, 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 Problem8
- Device Difficult to Program or Calibrate7
- No Apparent Adverse Event5
- Patient Device Interaction Problem5
- Obstruction of Flow4
- Device Operates Differently Than Expected3
- Material Integrity Problem3
- Mechanical Problem3
Patient problems
- No Consequences Or Impact To Patient16
- Hyperglycemia14
- Hypoglycemia4
- Elevated Ketones/ Diabetic Ketoacidosis1
- Swelling1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR LIP RING HAD CRACK AND MISSING THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE. 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 10324753 ↗MalfunctionApr 10, 2020Obstruction of Flow; Obstruction of Flow
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP DID NOT WORK WHEN CUSTOMER PUT NEW BATTERY. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS AND NEW BATTERIES WERE NOT ACCEPTED AND THEY HAD TO TURN OFF INSULIN PUMP TO RESTART. 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 9950152 ↗InjuryMar 20, 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 REPORTED VIA PHONE CALL THAT THEY WENT TO EMERGENCY MEDICAL SERVICES AND THEY TOOK TO EMERGENCY ROOM AND GET HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2020. CUSTOMER¿S BLOOD GLUCOSE WAS OVER 400 MG/DL IN THE HOSPITAL. CUSTOMER WAS TREATED WITH INSULIN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 9859329 ↗MalfunctionMar 18, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ANOMALY. IT WAS REPORTED THAT BUTTONS WERE STUCK AND CRACKED AROUND BATTERY AREA. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9847974 ↗MalfunctionMar 11, 2020Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem; Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED UNEXPECTED RESTART ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER WAS CHANGING BATTERY WHEN THE ALARM OCCURRED. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER ABLE TO COMPLETE REWIND. ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9816967 ↗MalfunctionDec 18, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT ACT BUTTON WAS NOT WORKING. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 89 MG/DL. THE INSULIN PUMP STOPPED WORKING. THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE 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 9487461 ↗MalfunctionDec 16, 2019Premature Discharge of Battery; Premature Discharge of Battery
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9472116 ↗MalfunctionSep 25, 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 SCREEN HAD SCRATCHES AND DIFFICULT TO READ IT. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE AND REWINDING SLOWER THAN PAST. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9115205 ↗MalfunctionJul 26, 2019Device Difficult to Program or Calibrate; Material Integrity Problem; Device Difficult to Program or Calibrate; Material Integrity Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP'S BUTTONS ARE HARD TO PRESS AND HAD TO PRESS MORE THAN ONCE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT IT WAS DIFFICULT TO REMOVE BATTERY FROM THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8830796 ↗MalfunctionJul 10, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 88 MG/DL. CUSTOMER REPORTED THAT THE ACT BUTTON OF THE INSULIN PUMP WAS UNRESPONSIVE. THE CUSTOMER WAS ADVISED TO DISCONTINUE 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 8774638 ↗InjuryJun 13, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 39 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD DAMAGED AT RESERVOIR LIP RING AND SCREEN. THE CUSTOMER REPORTS THAT RESERVOIR WAS ABLE TO LOCKED INTO THE PLACE. CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING TO LOW BLOOD GLUCOSE EPISODE. THE CUSTOMER WAS TREATED WITH CEREAL BARS AND APPLE JUICE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8694510 ↗MalfunctionJun 7, 2019Premature Discharge of Battery; Premature Discharge of Battery
CUSTOMER'S HUSBAND REPORTED VIA PHONE CALL WIFE'S INSULIN PUMP HAD UNEXPECTED RESTART. A COLD RESET WAS PERFORMED. CUSTOMER ALSO HAD BLOOD GLUCOSE OF UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS ABLE TO CLEAR THE ALARMS. THE CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP. DURING TROUBLESHOOTING THE INSULIN PUMP RECEIVED ANOTHER PUMP ERROR. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8677767 ↗InjuryJun 4, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 440 MG/DL TO 460 MG/DL. THE CUSTOMER STATED THAT THE ACT BUTTONS WAS RESPONDING BUT IT WAS HARD TO PRESS. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN PUMP. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8665592 ↗MalfunctionMay 14, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WAS LESS RESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE BATTERY CAP STRIPPED AND CHIPPED AS WELL AS RANDOM NO DELIVERY. CUSTOMER ALSO STATED THAT THE GRINDING NOISE ON REWIND. TROUBLESHOOTING WAS NOT PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8607090 ↗InjuryApr 12, 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 REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AS WELL AS HYPOGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 57 MG/DL AND 400 MG/DL. THE CURRENT BLOOD GLUCOSE LEVEL WAS 400 MG/DL.. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH MILK AND BANANA AND PEANUT BUTTER FOR LOW BLOOD GLUCOSE AND WITH INJECTION AND INSULIN PUMP FOR HIGH BLOOD GLUCOSE LEVELS. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER REPORTS INSULIN EXITED. THE CUSTOMER ALSO REPORTED THE DRIVE SUPPORT CAP APPEARS NORMAL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 8508612 ↗MalfunctionFeb 26, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP BUTTONS WERE LESS RESPONSIVE AND HARDER TO PRESS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP MOTOR SOUNDS LABORED. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8369286 ↗MalfunctionJan 15, 2019No Display/Image; No Display/Image
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS COMPLETELY DEAD. CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE AFTER INSERTING NEW BATTERY INSULIN PUMP WAS NOT POWER ON. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8247304 ↗MalfunctionNov 20, 2018No Display/Image; Material Integrity Problem; Power Problem; No Display/Image; Material Integrity Problem; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP TURNED OFF ON ITS OWN. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED THAT THE BATTERY COMPARTMENT GOT DAMAGED DURING BATTERY CAP REMOVAL. 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 WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8090306 ↗InjuryNov 13, 2018Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE WAS 251 MG/DL. CUSTOMER STATES OTHER BLOOD GLUCOSE LEVEL IN RANGE 400 MG/DL TO 500 MG/DL. CUSTOMER TREATED WITH MULTIPLE DAILY INSULIN. CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8062950 ↗MalfunctionNov 7, 2018Adverse 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 REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 440 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8049510 ↗MalfunctionNov 1, 2018Intermittent Communication Failure; Intermittent Communication Failure
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED WATCHDOG TIME OUT ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD BLANK DISPLAY AND DISPLAY DID NOT RETURN. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8031589 ↗InjurySep 17, 2018No Apparent Adverse Event; No Apparent Adverse Event
CUSTOMER REPORTED VIA PHONE CALL HIGH BLOOD GLUCOSE LEVELS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE LEVELS VIA INSULIN PUMP. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 74 MG/DL. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVELS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 7883486 ↗MalfunctionAug 21, 2018No Display/Image; No Display/Image
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180 MG/DL AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS PERFORMED AND THE DISPLAY DID NOT RETURN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7800442 ↗InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL EXPERIENCING HIGH BLOOD GLUCOSE LEVELS OF 600MG/DL. THE CUSTOMER STATES THEY TREATED WITH MANUAL INJECTION. THE INSULIN PUMP IS NOT BEING REPLACED AND IS NOT EXPECTED TO RETURN FOR ANALYSIS. NO FURTHER DETAILS ARE GIVEN.
Patient problems: Hyperglycemia
MAUDE report 7728720 ↗MalfunctionMay 23, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND A MOTOR POSITION ENCODER ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. 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 7536274 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P150019, 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-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- 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-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- 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-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- 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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