Paradigm® REAL-Time Revel™ MMT-723NAL (UDI 00613994904331)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-723NAL PRDGM INS V2.4 CL EN PR · Class 3
All models of Paradigm REAL-Time Revel (180)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Paradigm Revel insulin pump delivers insulin continuously for diabetes care. The 34 adverse event reports mostly describe the pump alarming, showing error codes, failing to prime or rewind, buttons not working, and insulin leaking or the screen cracking; several mention blood sugar running high. There are 7 reports of injury and no deaths, and 27 malfunctions. 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
- 34
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00613994904331), received between Jun 8, 2017 and Dec 18, 2019 — classified as 7 injuries, 27 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
- Material Protrusion/Extrusion4
- Priming Problem4
- Break3
- Device Operates Differently Than Expected3
- Mechanical Problem3
- Device Difficult to Program or Calibrate2
- Failure to Cycle2
Patient problems
- No Consequences Or Impact To Patient20
- Hyperglycemia13
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN PUMP LOOSED DATE AND TIME WHEN THEY CHANGED BATTERIES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9488315 ↗MalfunctionJul 19, 2019Mechanical Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR FAILURE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD CRACK ON RESERVOIR SIDE, OUTSIDE THE SUNLIGHT SCREEN WAS HARDER TO READ. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8806392 ↗MalfunctionJun 26, 2019Premature Discharge of Battery; Mechanical Problem; Obstruction of Flow; Insufficient Device Problem Information; Priming Problem; Premature Discharge of Battery; Mechanical Problem; Obstruction of Flow; Insufficient Device Problem Information; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND ERROR CODE START WITH A AND E. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD TO PRIME REWIND MORE THAN ONCE AND NO DELIVERY ALARM AND ERASED SETTINGS WHEN CHANGING BATTERIES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8733873 ↗MalfunctionJun 19, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD BUTTON NOT WORKING WELL . THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. 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 8710914 ↗MalfunctionJun 14, 2019Failure to Cycle; Failure to Cycle
CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPRISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 142 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT INSULIN PUMP WAS NOT ABLE TO COMPLETE REWIND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8699338 ↗MalfunctionMay 15, 2019Mechanical Problem; Priming Problem; Mechanical Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN SQUIRTING OUT DURING MANUAL PRIME PROCESS AND INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 160 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 8610872 ↗MalfunctionMar 13, 2019Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING PRIME. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 346 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS DROPPED OR BUMPED PRIOR TO THE ALARM OCCURRING. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL OR RECESSED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8415694 ↗MalfunctionFeb 7, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DID START BEEPING AFTER A COUPLE OF HOURS OF PUTTING ON THE INSULIN PUMP THEY WILL BEEP AND NOT DELIVER INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE WAS 100 MG/DL TO 150 MG/DL AND 200 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8313965 ↗MalfunctionFeb 5, 2019Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD NO DELIVERY ALARMED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATE THEY HAD TRIED ALL REMEDIES. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED 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 8304105 ↗MalfunctionOct 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 304 MG/DL AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7999732 ↗MalfunctionAug 29, 2018Priming Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS UNABLE TO PREPARING TO PRIME. CUSTOMER BLOOD GLUCOSE LEVEL WAS160MG/DL. TROUBLESHOOTING WAS NOT DONE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7831441 ↗MalfunctionAug 16, 2018Priming Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS SQUIRTED DURING PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7788230 ↗MalfunctionJul 17, 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 UNKNOWN AT THE TIME OF THE INCIDENT. IT WAS ALSO REPORTED THAT THE CLAMPS ARE BROKEN OFF AND HAD A CRACKED AROUND THE BATTERY CAP. TROUBLESHOOTING FOR INSULIN PUMP WAS COMPLETED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7693330 ↗MalfunctionJun 13, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE CUSTOMER WAS UNABLE TO REWIND THE INSULIN PUMP DUE TO ALARM. 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 7595191 ↗MalfunctionApr 18, 2018Device Slipped; Material Protrusion/Extrusion
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED A33 COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE ALARM OCCURRED WHEN TRIED TO FILL THE RESERVOIR AND PLACE IN PUMP PRIME REWIND . THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED/ LOOSE/STICKING OUT. 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 7442119 ↗MalfunctionMar 22, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 299 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE MIGHT HAVE BEEN BUMPED. 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 EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7364101 ↗MalfunctionFeb 16, 2018Insufficient Flow or Under Infusion
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD THE UNDER DELIVERY OF THE INSULIN. CUSTOMER ALLEGES THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160 MG/DL AT THE TIME OF THE INCIDENT AND THE CURRENT BLOOD GLUCOSE VALUE OF THE CUSTOMER WAS 148 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7277551 ↗MalfunctionJan 11, 2018Failure to Prime; Improper Flow or Infusion
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME LOOP AND INSULIN SQUIRTED OUT IF THE TUBING DURING MANUAL PRIME. THE CUSTOMER¿S BLOOD GLUCOSE WAS 166 MG/DL AT THE TIME OF THE INCIDENT. DURING TROUBLESHOOTING, THE CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR, BUT INSULIN CONTINUED TO DRIP AFTER LETTING GO OF THE ACT BUTTON DURING PRIME. THE CUSTOMER INDICATED 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 7183270 ↗InjuryJan 3, 2018High Readings
CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE VALUE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 434MG/DL AND THEN WENT UP TO 600MG/DL AND THEN 586MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 520MG/DL. CUSTOMER STATED SHE GAVE HERSELF A BOLUS WITH HER PUMP TO TREAT FOR HIGH BLOOD GLUCOSE VALUE. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE VALUE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7161502 ↗MalfunctionDec 20, 2017Device Displays Incorrect Message
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 87 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS DECLINED TROUBLESHOOTING. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7136398 ↗MalfunctionDec 19, 2017Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 240 MG/DL. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7132394 ↗InjuryNov 30, 2017Device Displays Incorrect Message
CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 307 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 586 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED THE PUMP TO TREAT. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER STATED THE MOTOR STOPPED DURING BOLUS DELIVERY AND THEIR BLOOD GLUCOSE WAS ALMOST 600 MG/DL. THE CUSTOMER ALSO GOT A MOTOR POSITION ENCODER ERROR. TROUBLESHOOTING WAS COMPLETED FOR THE MOTOR ISSUES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7072473 ↗InjuryNov 30, 2017Looping; High Test Results
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BLOOD GLUCOSE WAS HIGH AND THE INSULIN PUMP HAD PRIME REWIND ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 499MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 100 MG/DL. THE CUSTOMER REPORTED THAT THE PUMP WAS STUCK IN THE REWIND POSITION. THE CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE CUSTOMER STATED THAT THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE AS THE PUMP WAS NOT WORKING. 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: Hyperglycemia
MAUDE report 7071254 ↗InjuryNov 27, 2017Break; Excess Flow or Over-Infusion; Material Protrusion/Extrusion
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL OF 50 MG/DL. THE CUSTOMER HAD NOT REPORTED SYMPTOMS. THE CUSTOMER TREATED WITH FOOD. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 50 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER'S CURRENT BLOOD GLUCOSE VALUE WAS 114 MG/DL. CUSTOMER REPORTED HE WAS HOSPITALIZED OVER THE WEEKEND. THINKS THAT THE PUMP MAY HAVE BEEN THE REASON HE WAS HOSPITALIZED. I HAVE BEEN EXPERIENCING LOWS AND HAD TO GO TO THE HOSPITAL. CUSTOMER HAS BEEN EXPERIENCING LOW BGS FOR SINCE (B)(6). TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WENT IN EMERGENCY MEDICAL SERVICE AND WAS HOSPITALIZED ON (B)(6). THE BLOOD GLUCOSE VALUE WHEN ADMITTED TO HOSPITAL WAS 87 MG/DL. THE CUSTOMER COMPLAINED ABOUT PUMP MAY HAVE BEEN OVER DELIVERING. THE CUSTOMER CAUSE OF HOSPITALIZATION PER HEALTHCARE PROFESSIONAL'S WAS NONE. THE CUSTOMER OUTCOME OF THE HOSPITALIZATION : KEEP PUMP OFF AND TAKE INSULIN SHOTS ON SUNDAY UNTIL HE SAW DOCTOR MONDAY AND AGAIN TODAY. CUSTOMER NOT WEARING THE PUMP AT TIME OF HOSPITALIZATION. CUSTOMER REPORTS PROGRAMMING IS ACCURATE. CUSTOMER ADDITIONALLY STATED BLOOD GLUCOSE VALUE WAS 40 MG/DL AT TIME OF INCIDENT. CUSTOMER'S CURRENT BLOOD GLUCO
Patient problems: Hypoglycemia
MAUDE report 7060505 ↗MalfunctionSep 29, 2017Device Displays Incorrect Message
CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM DURING REWIND/PRIME SEQUENCE. CUSTOMER'S BLOOD GLUCOSE WAS 300MG/DL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND WAS ADVISED TO REFER BACK-UP PLAN, PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. CUSTOMER DECLINE TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND A REPLACEMENT PUMP WILL BE SENT.
Patient problems: Hyperglycemia
MAUDE report 6905002 ↗
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-1593-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- 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-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-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-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.
How reports and recalls are matched · Editorial policy · Report an error on this page