PARADIGM® REAL-time MMT-522LNAPRecalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-522LNAP PRDGM INS V2.4 PL EN LK · Class 3
All models of PARADIGM REAL-time (95)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic MiniMed Paradigm insulin pump delivers insulin continuously through a catheter. Reports mostly describe error messages and alarms, buttons not responding, battery and power trouble, cracked parts around the reservoir, and pumping that stops or delivers no insulin. There are 37 reports, with no deaths and 9 injuries; some describe high blood sugar after insulin delivery was interrupted. 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
- 37
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00613994407702), received between Jun 8, 2017 and Jun 4, 2026 — classified as 9 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (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.
Reports received per month
Most reported problems
Device problems
- Device Displays Incorrect Message7
- Mechanical Problem6
- Device Difficult to Program or Calibrate5
- Power Problem5
- Patient Device Interaction Problem4
- Obstruction of Flow3
- Adverse Event Without Identified Device or Use Problem2
- Device Operates Differently Than Expected2
Patient problems
- No Consequences Or Impact To Patient25
- Hyperglycemia10
- Dyspnea1
- Hypoglycemia1
- Nausea1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED RECEIVED THE BUTTON ERROR ALARM IN THE INSULIN PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-522LNAP. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-522LNAP WAS REQUESTED AND THE DEVICE WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25390733 ↗MalfunctionSep 1, 2020Mechanical Problem; Obstruction of Flow; Date/Time-Related Software Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Date/Time-Related Software Problem; Power Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD FREQUENT ALARMS, HAD UNEXPLAINED RANDOM NO DELIVERY ALARMS, HAD REJECTED NEW BATTERIES, THE CLOCK WAS SLOW, REWIND TOOK LONGER AND THE PIECES AROUND THE RESERVOIR AREA HAD CRACKED. 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 10480836 ↗MalfunctionJul 20, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE BUTTONS WERE NOT RESPONDING. THE INSULIN PUMP HAD GOT WET. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10294331 ↗MalfunctionJul 15, 2020Failure to Cycle; Failure to Cycle
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10274745 ↗MalfunctionJul 8, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALARMS. CUSTOMER DECLINED TO TROUBLESHOOTING WITH 24 HOURS HELPLINE. 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 10244106 ↗MalfunctionJul 1, 2020Mechanical Problem; Environmental Compatibility Problem; Mechanical Problem; Environmental Compatibility Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED INSULIN PUMP EXPOSED TO MAGNETIC FIELD. 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 10217108 ↗MalfunctionMar 5, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER STATED INSULIN PUMP'S ACT AND SPACE BUTTONS WERE NOT RESPONDING 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 9791986 ↗InjuryJan 23, 2020Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WENT TO EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 427 MG/DL. CUSTOMER TREATED WITH INSULIN SHOT 4.5 UNITS AND CURRENT BLOOD GLUCOSE LEVEL WENT DOWN TO 353 MG/DL FROM 427 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS TREATMENT WITH INSULIN IN HOSPITAL. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9620699 ↗MalfunctionAug 30, 2019Failure to Cycle; Priming Problem; Failure to Cycle; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE WAS FILLING HER TUBING WHEN THE INSULIN PUMP ALARMED WITH COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 254 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8948605 ↗MalfunctionJul 11, 2019Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Insufficient Flow or Under Infusion; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER ALLEGING POSSIBLE INSULIN PUMP UNDER DELIVERY. THE CUSTOMER¿S HIGH BLOOD GLUCOSE WAS 300 MG/DL AT THE TIME OF INCIDENT. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER TREATED WITH MANUAL INJECTION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8779945 ↗MalfunctionJul 5, 2019Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS STUCK AND THE SCREEN WAS FROZEN AS WELL THE BUTTONS WERE NOT RESPONDING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 128 MG/DL AT TIME OF INCIDENT. THE CUSTOMER STATED THAT THEY WERE UNABLE TO CLEAR THE ALARM. 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. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8763484 ↗MalfunctionJul 5, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 102 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 8763252 ↗MalfunctionApr 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A UNEXPECTED RESTART. A COLD RESET WAS PERFORMED ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 90 MG/DL. TROUBLESHOOTING STEPS WERE PROVIDED FOR PUMP ERROR. CUSTOMER STATES THAT NO PUMP ERROR RECURRING DURING NORMAL PUMP USE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8521767 ↗InjuryMar 28, 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 570 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT THE INSULIN PUMP HAD DIED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8459113 ↗MalfunctionMar 22, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD MULTIPLE ISSUES WITH INSULIN PUMP. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP HAD KEYPAD RESPONSIVENESS, SHORTENED BATTERY LIFE AND INSULIN PUMP NOISY DURING REWINDS. CUSTOMER STATED THAT THE TIME CLOCK WAS ADVANCES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8443643 ↗MalfunctionFeb 1, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 157 MG/DL AT THE TIME OF INCIDENT. INSULIN PUMP HAD A MOTOR POSITION ENCODER ERROR ALARM. DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8295770 ↗MalfunctionDec 26, 2018Display or Visual Feedback Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8195435 ↗InjuryDec 20, 2018No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 463 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATES THE RESERVOIR WAS ABLE TO LOCK IN PLACE. CUSTOMER STATES SHE DID NOT HAVE ANY ALARMS BUT THE PUMP WAS MAKING NOISES ON THE PUMP. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS AND TREATMENT OF HIGH BLOOD GLUCOSE. CUSTOMER DECLINED TO TROUBLESHOOTING FOR THEIR HIGH BLOOD GLUCOSE LEVELS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8183610 ↗MalfunctionOct 12, 2018Power Problem; Power Problem
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD FAILED BATTERY TEST ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 284 MG/DL AT THE TIME OF INCIDENT. PRODUCT WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7959793 ↗MalfunctionSep 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS 124MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7897004 ↗MalfunctionSep 5, 2018Power Problem; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP GOT A NO POWER ALERT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED BATTERY ISSUES. TROUBLESHOOTING WAS NOT PROVIDED. ALERT WAS NOT CLEARED. THE INSULIN PUMP WILL NOT RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7848947 ↗MalfunctionJul 31, 2018Power Problem; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP GOT A FAILED BATTERY ALARM. THE BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE PRODUCT WILL NOT BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7734094 ↗InjuryJun 6, 2018Device Displays Incorrect Message
THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2018 DUE TO DEHYDRATION WITH HIGH BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 240 MG/DL AND CURRENT BLOOD GLUCOSE WAS 108 MG/DL. CUSTOMER REPORTED THE FOLLOWING SYMPTOMS RELATED TO THEIR HIGH BLOOD GLUCOSE WERE USUALLY DIFFICULTY BREATHING AND NAUSEA. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH THE INSULIN PUMP. CUSTOMER WENT TO THE EMERGENCY ROOM AS HE WAS DEHYDRATED BECAUSE HEART RATE HAD GONE UP HIGH. THOUGHT SHE WAS DEHYDRATED AND CONCERNED WITH HER HEART WAS 143 OVER 76. BLOOD GLUCOSE VALUE WHEN ADMITTED TO HOSPITAL WAS 193 MG/DL. WHEN ADMITTED AND AFTER TAKING INSULIN 2 HOURS LATER IT WAS 140 MG/DL. CUSTOMER WAS WEARING THE PUMP AT TIME OF HOSPITALIZATION. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATES THAT SHE WANTS THE PUMP TO ALARM HER WHEN THE RESERVOIR IS LOW AND TO ALARM SO SHE CAN HEAR IT. AFTER REVIEWING THE PUMP SETTING HER AUDIO IS SET TO BEEP LONG AND HER LOW RES SETTINGS ARE SET TO ALARM AT 20 UNITS. CUSTOMER NOTICED THAT THE PUMP WAS NOT ALARMING WHEN INSULIN WAS LOW AND WENT TO
Patient problems: Dyspnea; Hyperglycemia; Nausea
MAUDE report 7572540 ↗MalfunctionJun 5, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY HAD EXPERIENCED THE UNEXPECTED ALARM. THE TROUBLESHOOTING WAS PERFORMED FOR THE INSULIN PUMP ERROR ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7572255 ↗MalfunctionFeb 24, 2018Device Operates Differently Than Expected
CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WILL BE RETURNED DEVICE FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7294155 ↗
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-1750-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
- Z-1749-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Insulin Pump (MMT-522, MMT-722)
- Z-1256-2025 · Jan 31, 2025 · Open, ClassifiedParadigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
- Z-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- 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-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-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-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page