Paradigm® REAL-Time Revel™ MMT-523LNAP (UDI 00643169151307)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523LNAP PRDGM INS V2.5 PL 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 Medtronic MiniMed Paradigm REAL-Time Revel insulin pump appears in 89 adverse event reports, with no deaths and 40 injuries. Many reports describe incorrect messages, programming difficulty, and button errors. Listed patient problems include high and low blood sugar. 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
- 89
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00643169151307), received between Jun 5, 2017 and Aug 4, 2020 — classified as 40 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (13 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 Problem16
- Device Difficult to Program or Calibrate13
- Device Displays Incorrect Message13
- No Apparent Adverse Event9
- Break6
- No Display/Image6
- Patient Device Interaction Problem6
- Premature Discharge of Battery6
Patient problems
- Hyperglycemia42
- No Consequences Or Impact To Patient37
- Hypoglycemia9
- Elevated Ketones/ Diabetic Ketoacidosis2
- Complaint, Ill-Defined1
- Diarrhea1
- No Known Impact Or Consequence To Patient1
- Vomiting1
Recent adverse event reports
The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WERE EXPERIENCING LOW BLOOD GLUCOSE AND INSULIN PUMP HAD BUTTON ERROR. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 34 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH FOOD. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 10360982 ↗InjuryAug 3, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER¿S BLOOD GLUCOSE LEVELS WERE 436 MG/DL AND 369 MG/DL. THE CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP RECEIVED BUTTON ERROR AND NO DELIVERY ALARM. THE NO DELIVERY ALARM WAS RESOLVED BY COMPLETE SET CHANGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 10355753 ↗MalfunctionAug 3, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. 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 10355555 ↗InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER'S DAUGHTER REPORTED VIA PHONE CALL THAT HER MOTHER WAS IN HOSPITAL DUE TO LOW BLOOD GLUCOSE AND DEHYDRATION ON (B)(6) 2020 AT 8 PM AND SHE WAS OFF THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 64 MG/DL. CUSTOMER HAD DIARRHEA AND VOMITING. CUSTOMER WAS TREATED WITH FLUIDS AND HYDRATES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Complaint, Ill-Defined; Diarrhea; Hypoglycemia; Vomiting
MAUDE report 10274285 ↗MalfunctionJul 7, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER STATED THAT THE TIME CLOCK WAS ADVANCED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 10238883 ↗MalfunctionJun 24, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR COMPARTMENT CHIPPED OFF NOT A RING THAT IT ACTUALLY HAVE. THE CUSTOMER STATED THAT THE RESERVOIR DID NOT LOCK INTO 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 10187968 ↗InjuryApr 9, 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 HAD EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 495 MG/DL. THE CUSTOMER WAS TREATED WITH SYRINGE AND BOLUS DELIVERY. THE CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERY. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9942459 ↗MalfunctionMar 4, 2020Priming Problem; Priming Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SEVERAL TIMES FOR INSULIN PUMP REFILLS BUT SHE WAS NOT HAVING ANY SUCCESS AT RESOLVING ISSUE. 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 9784635 ↗MalfunctionJan 6, 2020Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE BLOOD GLUCOSE OF THE CUSTOMER WAS UNKNOWN. CUSTOMER WAS GETTING REWIND PRIME AND THEN NO DELIVERY. CUSTOMER STATES INSULIN CONTINUES TO DRIP AFTER MOTOR STOPS DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATES THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP. THE CUSTOMER ADVISED TO REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9552513 ↗MalfunctionOct 20, 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 ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 132 MG/DL. 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 DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9211936 ↗MalfunctionOct 17, 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
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF THE INSULIN PUMP WERE HARDER TO PUSH AND MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD CRACK NEAR BATTERY CAP AND NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9201287 ↗MalfunctionSep 19, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY AND UNEXPECTED RESTART ALARM. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THAT THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT NUMBERS WERE RAMPING ON THEIR OWN. CUSTOMER STATED THE SCROLL BAR WAS NOT MOVING WITH NO INPUT. 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 9086229 ↗MalfunctionSep 18, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED A BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE TIME WAS MOVING. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACKUP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9080616 ↗MalfunctionSep 6, 2019Mechanical Problem; Power Problem; No Apparent Adverse Event; Mechanical Problem; Power Problem; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP HAD RECEIVED MOTOR ERROR TWICE AND A FAILED BATTERY TEST ALERT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 285 MG/DL AT THE TIME. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS BEEPING AND THE BATTERY DISPLAY WAS EMPTY AND A CIRCLE WAS SHOWING. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING AND IT WAS REPORTED THAT THE CUSTOMER WAS ABLE TO COMPLETE THE INSULIN PUMP REWIND. THE CUSTOMER PERFORMED SELF TEST AND IT WAS PASSED. 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 8968314 ↗MalfunctionAug 29, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM AND DRIVE SUPPORT CAP ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED 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 8943646 ↗MalfunctionAug 13, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS BROKEN AT THE PART OF RING. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. CUSTOMER REPORTED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. 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 8891471 ↗MalfunctionJul 22, 2019Premature Discharge of Battery; Connection Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Connection Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED AND HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT RESERVOIR DOES NOT LOCK IN PLACE WHILE INSERTED. 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 8811034 ↗MalfunctionJul 22, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 326 MG/DL. CUSTOMER STATED THAT THE NUMBERS KEPT SCROLLING ON THE INSULIN PUMP'S MENU. CUSTOMER STATED THAT INSULIN PUMP WAS NOT BEEN DROPPED NOR BUMPED AND NOR EXPOSED TO WATER. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVISE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8810467 ↗InjuryJun 27, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND INSULIN PUMP HAD BUTTON ERROR ALARM AND UNEXPECTED RESTART. BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS 500 MG/DL. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8742503 ↗MalfunctionJun 21, 2019Computer Software Problem; Application Program Version or Upgrade Problem; Computer Software Problem; Application Program Version or Upgrade Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERRORS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 112 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTS THEY WERE UNABLE TO CLEAR THE ALARM(S) 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 DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8721454 ↗InjuryMay 6, 2019No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event
CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH INSULIN FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER DID NOT MENTION ANY SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THE DISPLAY RETURNED AFTER THE INSULIN PUMP RESTART. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8581062 ↗InjuryApr 26, 2019No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 680 MG/DL. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE CUSTOMER WAS TREATED BY INSULIN DRIP. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 8554421 ↗MalfunctionApr 5, 2019Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150 MG/DL. THE CUSTOMER REPORTED THAT THEY HAD RECEIVED BUTTON ERROR AND BUTTONS WERE NOT RESPONDING. 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 8486021 ↗InjuryMar 4, 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 REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OVER 600 MG/DL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 230 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTS THAT INSULIN EXITED WITH QUICK RELEASE. CUSTOMER DID NOT ALLEGE FOR UNDER DELIVERING. CUSTOMER STATED THAT THERE WAS NO AIR BUBBLE AND LEAK. CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8385470 ↗InjuryMar 3, 2019Adverse Event Without Identified Device or Use Problem
CUSTOMER'S FATHER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 476 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER WILL NOT BE RETURNED DEVICE FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8385029 ↗
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-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-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- 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-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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