Paradigm® REAL-Time Revel™ MMT-723RNAH (UDI 00613994904416)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-723RNAH PRDGM INS V2.4 PK EN RC · Class 3
All models of Paradigm REAL-Time Revel (180)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00613994904416), received between Jun 7, 2017 and Sep 25, 2019 — classified as 11 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (5 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 Message5
- Adverse Event Without Identified Device or Use Problem3
- Mechanical Problem3
- No Apparent Adverse Event3
- No Display/Image3
- Patient Device Interaction Problem3
- Break1
- Component or Accessory Incompatibility1
Patient problems
- No Consequences Or Impact To Patient8
- Hyperglycemia7
- Hypoglycemia5
- Elevated Ketones/ Diabetic Ketoacidosis3
- High Blood Pressure/ Hypertension1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2019Failure to Cycle; Failure to Cycle
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALARMED FOR COMPROMISED FORCE SENSOR SYSTEM WHEN PRIMING AND TUBING. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER¿S BLOOD GLUCOSE WAS 119 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9115001 ↗InjuryJun 13, 2019Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS WERE 280 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE CUSTOMER WAS TREATED WITH INSULIN DRIP DURING HOSPITALIZATION. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 8694654 ↗InjuryJun 11, 2019Mechanical Problem; Obstruction of Flow; No Apparent Adverse Event; Mechanical Problem; Obstruction of Flow; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS ON (B)(6) 2018. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN DRIP. THE INSULIN PUMP HAD MOTOR ERROR AND NO DELIVERY ALARM. CUSTOMER REPORTS THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER DID NOT RECEIVE AN MOTOR POSITION ENCODER ERROR ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE PUMP. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE VALUE. CUSTOMER WAS ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 8686835 ↗MalfunctionApr 24, 2019Premature Discharge of Battery; Premature Discharge of Battery
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATES THE PUMP WAS STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. UNEXPECTED RESTART ALARM WAS NOT RECURRING DURING NORMAL PUMP USE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8542785 ↗MalfunctionMar 5, 2019No Display/Image; Power Problem; Patient Device Interaction Problem; No Display/Image; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY INSULIN PUMP WAS BROKEN AND IT WAS NOT WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE LABEL STICKER PEELED OFF AND FRONT STICKERS OF THE INSULIN PUMP WAS WORN OFF. CUSTOMER ALSO STATED THAT THE BAD BATTERY ALERT. CUSTOMER TROUBLESHOOTING WAS DECLINED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8389133 ↗MalfunctionFeb 8, 2019No Display/Image; Mechanical Problem; Moisture or Humidity Problem; Patient Device Interaction Problem; No Display/Image; Mechanical Problem; Moisture or Humidity Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS EXPOSED MOISTURE AND IT WAS ALARMED PUMP ERROR AS WELL AS HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT CUSTOMER STATED THAT THEY DROPPED THE INSULIN PUMP ON THE FLOOR MANY TIMES SO THE INSULIN PUMP RECEIVED MOTOR ERROR ALARMS. THE CUSTOMER 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 8319686 ↗InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE WHILE UNDER HOSPITALIZATION FOR HIGH BLOOD PRESSURE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 138MG/DL. THE CUSTOMER WAS AT 138 MG/DL AT THE TIME OF THE CALL. 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. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER HUNG UP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: High Blood Pressure/ Hypertension; Hypoglycemia
MAUDE report 8188328 ↗InjuryNov 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 46 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 129 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED FOOD TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED BUT THE PUMP PASSED A SELF TEST. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8092476 ↗InjuryNov 4, 2018No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 525 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE WAS 599 MG/DL. THE CUSTOMER ALSO REPORT THAT INSULIN PUMP HAD BLANK DISPLAY AND CUSTOMER ALSO STATE HER PUMP VIBRATED WITH AN ALARM AND THEN TURNED OFF. CUSTOMER STATES THE CONTACTS ON THE BATTERY CAP ARE NOT MISSING OR DAMAGED. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS AND TREATMENT OF THEIR HIGH BLOOD GLUCOSE EPISODES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 8036496 ↗InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH AND LOW BLOOD GLUCOSE LEVEL IN THE LAST TWO WEEKS. BLOOD GLUCOSE LEVEL RANGED FROM 42 TO 350 MG/DL. CUSTOMER TREATED WITH FOOD FOR THE LOW READING AND WITH INSULIN PUMP FOR THE HIGH READING. BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 77 MG/DL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER DECLINED TO CHECK FOR POSSIBLE SITE/INSULIN ISSUES AND SETTINGS. CUSTOMER DID NOT TROUBLESHOOT FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WAS NOT REPLACED OR RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 7820562 ↗MalfunctionJul 19, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT. CUSTOMER TREATED WITH MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE LEVEL. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7705463 ↗MalfunctionJan 10, 2018Break
CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR LIP WAS BREAKING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7179804 ↗InjuryDec 29, 2017Failure to Power Up; Device Displays Incorrect Message
THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER HAD LOW BLOOD GLUCOSE OF 58 MG/DL. THE CUSTOMER ALSO RECEIVED MULTIPLE INSULIN PUMP ERRORS AND DRIVE SUPPORT CAP WAS FLUSHED. THEIR CURRENT BLOOD GLUCOSE WAS 48 MG/DL. LOW BLOOD GLUCOSE WAS TREATED WITH JUICE AND FOOD. CUSTOMER STATED THAT THE INSULIN PUMP HAS STOPPED WORKING. IT SAYS NO POWER AND INSULIN PUMP ERROR AND THERE ARE TWO LONG LINES WITH A VERTICAL BAR INSIDE. THE REST OF THE INSULIN PUMP IS DARK AND IT STARTS COUNTING UP. CUSTOMER STATED THAT, THE HEALTHCARE PROFESSIONAL CHANGED HER BASAL THE OTHER DAY AND SHE WAS HIGH THIS MORNING AND TREATED WITH INSULIN AND THEN TREATED WITH A LITTLE MORE INSULIN. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS OVER DELIVERING. CUSTOMER DECLINES TO CONTINUE TROUBLESHOOT. CUSTOMER STATED THAT, THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER STATED THAT, THEY DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. CUSTOMER STATED THAT, THERE WERE NOT UNATTENDED ALARMS. ASSISTED CUSTOMER IN REVIEWING ALARM HISTORY. ALARM OCCURRED DURING THE REWIND AND PRIME SEQUENCE. CUSTOMER ADVISED TO REPLACE AND REFER TO BACK-UP PLAN. THE INSULIN PUMP WILL BE RETUR
Patient problems: Hypoglycemia
MAUDE report 7154535 ↗MalfunctionNov 20, 2017Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP ALARMED FAILED BATTERY TEST. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 134 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7045501 ↗InjuryNov 3, 2017Dent in Material
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 599 MG/DL. PATIENT'S CURRENT BLOOD GLUCOSE VALUE: 312 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA, DRY MOUTH AND DEHYDRATION. DRIVE SUPPORT CAP APPEARS NORMAL (SLIGHTLY INDENTED). THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7000311 ↗InjurySep 15, 2017Device Displays Incorrect Message; Component or Accessory Incompatibility
THE CUSTOMER REPORTED VIA PHONE CALL THAT AFTER A KNEE SURGERY THEY EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL OF 444 MG/DL AND THAT THE INSULIN PUMP ALSO ALARMED MOTOR ERROR TWICE. TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE WAS PERFORMED. THE CUSTOMER TREATED WITH INJECTIONS AND WAS ALSO HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 527 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2017 AT 12:00 P.M. WITH THE BLOOD GLUCOSE OF 444 MG/DL. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING HOSPITALIZATION. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER DECLINED FURTHER HIGH BLOOD GLUCOSE TROUBLESHOOTING, SO MOTOR ERROR TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MAGNETIC RESONANCE IMAGING DUE TO BEING TOLD THAT IT WAS OKAY TO WEAR IT DURING THE PROCEDURE. THE CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. 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 CUSTOMER ALSO MENTIONED RECEIVING BATTERY OUT LIMIT ALARM AND TROUBLESHOOTING FOUND THAT IT WAS
Patient problems: Hyperglycemia
MAUDE report 6869150 ↗MalfunctionSep 6, 2017Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP ALARMED MOTION SENSOR TEST FAILURE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6845421 ↗MalfunctionJul 14, 2017Device Inoperable; Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR FOLLOWED BY AN UNEXPECTED RESTART ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 88 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. NO SIGNIFICANT EVENT LEADING TO BUTTON ERROR OR KEYPAD ANOMALY WERE OBSERVED. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. NO TROUBLESHOOTING WAS PERFORMED ON THE UNEXPECTED RESTART ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6713802 ↗InjuryJun 8, 2017Excess Flow or Over-Infusion
IT WAS REPORTED THAT THE CUSTOMER RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017, WITH BLOOD GLUCOSE OF 54MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ABLE TO GET THEIR READING AS HIGH AS 62 MG/DL. THE CUSTOMER USED CARBS TO TREAT. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP DURING THE INCIDENT WITHIN LESS THAN 48 HOURS. TROUBLESHOOTING WAS COMPLETED AND THE NURSE BELIEVES THAT THE PUMP WAS OVER DELIVERING. THE CUSTOMER COMPLETED A SET CHANGE ON MONDAY EVENING AND WOKE UP TUESDAY MORNING AND THE PUMP HAD GIVEN ALL BUT 20 UNITS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 6624173 ↗InjuryJun 7, 2017Loose or Intermittent Connection
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 771 MG/DL ON (B)(6) 2017. THE CUSTOMER REPORTED FEELING TIRED AND VOMITING BEFORE THEIR HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER ALSO PASSED OUT IN THE BATHROOM. CUSTOMER'S BLOOD GLUCOSE ROSE TO 800 MG/DL AT ONE POINT. THE CUSTOMER DISCONNECTED FROM THE INSULIN PUMP AND RESORTED TO MANUAL INJECTIONS. THE CUSTOMER WAS UNSURE HOW THEIR HIGH BLOOD GLUCOSE EVENT OCCURRED. THE CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP FOR GREATER THAN 48 HOURS DURING THEIR HOSPITALIZATION. THE CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 103 MG/DL. TROUBLESHOOTING FOR THE INSULIN PUMP FOUND A FLUSHED DRIVE SUPPORT CAP. THE CUSTOMER REPORTED DROPPING THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6620259 ↗
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-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- 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-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- 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-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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