Paradigm® REAL-Time Revel™ MMT-523RNAH (UDI 00643169221529)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523RNAH PRDGM V2.5B PK 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 is a Medtronic Paradigm Revel insulin pump. The 60 reports mostly describe blank or dim screens, error and no-delivery alarms, worn buttons, priming problems, and insulin leaking or squirting out, along with blood sugar running high or low. 29 reports describe injuries and no deaths. No recalls name this device, and reports stopped after 2020.
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
- 60
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00643169221529), received between Jun 30, 2017 and Jun 22, 2020 — classified as 29 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (7 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 Problem7
- Patient Device Interaction Problem7
- Device Displays Incorrect Message6
- Break4
- Device Difficult to Program or Calibrate4
- Insufficient Device Problem Information4
- Mechanical Problem4
- Obstruction of Flow4
Patient problems
- No Consequences Or Impact To Patient27
- Hyperglycemia21
- Hypoglycemia16
- Elevated Ketones/ Diabetic Ketoacidosis2
- Nausea1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2020No Display/Image; No Display/Image
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. THE CUSTOMER REPORTED THAT INSULIN PUMP HAD BLANK DISPLAY. DISPLAY WAS RETURNED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 10178119 ↗InjuryApr 8, 2020Obstruction of Flow; Priming Problem; Obstruction of Flow; Priming Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PRIME FILL ANOMALY, NO DELIVERY ALARM AND HIGH BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. CUSTOMER TREATED THEIR BLOOD GLUCOSE VIA INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WENT DOWN TO 66 MG/DL. THE CUSTOMER STATED INSULIN SQUIRTED OUT OF THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 9936905 ↗InjuryApr 8, 2020Obstruction of Flow; Priming Problem; Obstruction of Flow; Priming Problem
CUSTOMER REPORTED VIA PHONE CALL HIGH BLOOD GLUCOSE LEVELS, NO DELIVERY ALARM AND PRIME FILL ANOMALY ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE LEVELS VIA INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WENT DOWN TO 66 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED INSULIN SQUIRTED OUT DURING THE CHANGING OF THEIR TUBING AND RESERVOIR. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 9936904 ↗MalfunctionMar 20, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE INSULIN PUMP HAD BLANK DISPLAY.
Patient problems: Hyperglycemia
MAUDE report 9858420 ↗MalfunctionSep 19, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ACT BUTTON WAS WORN AND DID NOT WORK. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. IT WAS REPORTED THAT THE INSULIN PUMP WAS OLD BUT THE OTHER BUTTONS WORKED. 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 9088014 ↗MalfunctionAug 30, 2019Mechanical Problem; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 135 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED DRIVE SUPPORT CAP WAS STICKING OUT. TROUBLESHOOTING WAS PERFORMED. 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8948481 ↗InjuryAug 5, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED VIA PHONE CALL BY THE CUSTOMER'S PARENT THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE IN THE 30 MG/DL RANGE AT THE TIME OF THE INCIDENT. THE CUSTOMER USED FOOD TO TREAT. THE CALLER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CALLER BELIEVED THE PUMP WAS OVER DELIVERING INTERMITTENTLY. TROUBLESHOOTING WAS NOT COMPLETED AS THE CALLER WAS NOT WITH THE CUSTOMER AT THE TIME OF THE CALL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8858547 ↗MalfunctionJul 17, 2019Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DIMMER SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED THAT INSULIN PUMP REJECTED NEW BATTERY AND RANDOM NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8797520 ↗InjuryJul 8, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow
CUSTOMER CALLED AND REPORTED THAT THEY GOT HOSPITALIZED 4 DIFFERENT TIMES WITH HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS SINCE EARLY (B)(6) 2019. THE CUSTOMER ALSO REPORTED LOW BLOOD GLUCOSE IN (B)(6) 2019. THE CUSTOMER STATED THEY DO NOT FEEL THEIR HIGHS OR LOWS. THE CUSTOMER DID NOT MENTION HOW THEY WERE TREATED. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED THE PUMP BUTTONS WERE HARDER TO PRESS AND THEY WERE GETTING UNEXPLAINED NO DELIVERY ALARMS. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Hypoglycemia
MAUDE report 8766264 ↗InjuryJun 21, 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 HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 401 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 320 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS VOMITING. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8721020 ↗MalfunctionJun 7, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL ACT BUTTON WAS NOT RESPONDING. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 254 MG/DL. THE TIME CLOCK WAS ADVANCES. ADVISED TO DISCONTINUE USE OF THE INSULIN 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 8677515 ↗InjuryJun 4, 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 HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 510 MG/DL. CUSTOMER REPORT THEY DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER WAS NOT USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT AND DIABETIC KETOACIDOSIS. CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING TO HIGH BLOOD GLUCOSE EPISODE AND DIABETIC KETOACIDOSIS. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 8666942 ↗InjuryJun 3, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL OF 31 MG/DL. THE CUSTOMER FEELS OK TO TROUBLESHOOTING LOW BLOOD GLUCOSE LEVEL. CUSTOMER REPORTED THAT THEY DID NOT CONTACTED THEIR HEALTH CARE PROFESSIONAL REGARDING THE LOW BLOOD GLUCOSE EVENT. THE CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING LOW BLOOD GLUCOSE. THE CUSTOMER WAS TREATED FOR THE LOW BLOOD GLUCOSE WITH FOOD. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. CUSTOMER ALSO REPORTED THAT THE ABOUT FOUR WEEKS AGO HE WAS DISPATCHED VIA EMERGENCY MEDICAL SERVICES AND TREATED FOR LOW BLOOD GLUCOSE. CUSTOMER TREATED WITH INTRAVENOUS INSULIN AND BREAKFAST. BASED ON CUSTOMER REPORT CUSTOMER DOES ALLEGE INSULIN PUMP WAS OVER DELIVERING. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 8662252 ↗InjuryApr 26, 2019Mechanical Problem; Mechanical Problem
CUSTOMER'S HUSBAND REPORTED VIA PHONE CALL THAT HIS WIFE EXPERIENCED LOW BLOOD GLUCOSE LEVEL OF 66 MG/DL. CUSTOMER TREATED WITH GLUCAGON AND NOW HER BLOOD GLUCOSE LEVEL WAS 143 MG/DL. THE CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING LOW BLOOD GLUCOSE. CUSTOMER ALSO REPORTED THAT THEY WERE STUCK DURING REWIND PROCESS. THE CUSTOMER WAS TREATED FOR THE LOW BLOOD GLUCOSE WITH GLUCOSE TABLET. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8554172 ↗MalfunctionMar 26, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER STATES RUBBER O-RING IN THE RESERVOIR COMPARTMENT CAME OUT OF THE INSULIN PUMP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8454386 ↗MalfunctionMar 6, 2019Failure 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 133 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS DRIPPING OUT AND NOT COUNTING DURING PRIME. 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8394547 ↗MalfunctionFeb 14, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR O RING WAS MISSING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT THE RESERVOIR WAS UNABLE TO LOCK IN PLACE. 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8340172 ↗InjuryFeb 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
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE VALUE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 41 MG/DL. THE CUSTOMER DID NOT PROVIDE INFORMATION ABOUT SYMPTOMS AND TREATMENT. THE CUSTOMER ALSO REPORTED DAMAGE TO BELT CLIP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8328653 ↗MalfunctionDec 17, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS A CRACK AND CHIPPED PIECE ON THE BATTERY COMPARTMENT AND THE WINDOW WHERE THE RESERVOIR COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE CUSTOMER 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 8168051 ↗MalfunctionNov 8, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
CUSTOMER'S SON REPORTED VIA PHONE CALL THAT THERE WAS DAMAGE ON RESERVOIR LIP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 175 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: No Consequences Or Impact To Patient
MAUDE report 8050265 ↗MalfunctionOct 30, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 129 MG/DL. THE CUSTOMER STATES THE BELT CLIP WAS BROKEN. THE CUSTOMER PERFORMED SELF-TEST AND IT DID PASS. ADVISED THE PUMP WILL NEED TO BE REPLACED. 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 8018433 ↗MalfunctionOct 15, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT THE RESERVOIR COMPARTMENT AND BATTERY COMPARTMENT WAS CRACKED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7964080 ↗MalfunctionAug 23, 2018Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND MOTOR POSITION ENCODER ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. 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 7808678 ↗InjuryAug 2, 2018Human-Device Interface Problem; Human-Device Interface Problem
THE CUSTOMER CALLED TO REPORT HIGH BLOOD GLUCOSE OF OVER 600 MG/DL AND REQUIRED MEDICAL INTERVENTION. TROUBLESHOOTING WAS NOT COMPLETED. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD CRACKS ON THE RESERVOIR AND BATTERY COMPARTMENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7745517 ↗InjuryJul 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER CALLED TO REPORT HIGH BLOOD GLUCOSE OF 401 MG/DL. TROUBLESHOOTING DETERMINED THE INSULIN PUMP IS WORKING AS DESIGNED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 7730304 ↗
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-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-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- 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-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- 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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