PARADIGM® REAL-time MMT-722NAB (UDI 00613994622594)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-722NAB PRDGM INS V2.4 BL EN PR · 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 cannula. The 60 reports mostly describe motor and sensor error alarms, pumps that stop delivering insulin, unresponsive buttons, cracked housings, and settings being lost, with users reporting high blood sugar (hyperglycemia) in 17 cases. Two reports involve death and 15 involve injury. No recalls name this device, and no reports have been filed in the past 12 months or the12 months before that.
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
- 2
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00613994622594), received between Jun 7, 2017 and Mar 13, 2020 — classified as 2 deaths, 15 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (12 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 Difficult to Program or Calibrate12
- Device Displays Incorrect Message11
- Mechanical Problem10
- Patient Device Interaction Problem6
- Failure to Cycle5
- Detachment of Device or Device Component4
- No Apparent Adverse Event4
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Consequences Or Impact To Patient40
- Hyperglycemia17
- Hypoglycemia4
- Death2
- Elevated Ketones/ Diabetic Ketoacidosis2
- 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.
MalfunctionMar 13, 2020Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM MOTOR ERROR ALARM. CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATED THAT INSULIN PUMP HAD NOT EXPOSED TO HIGH MAGNETIC FIELD AND DECLINED TO REPORT MOTOR POSITION ENCODER ERROR ALARM. 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 9828199 ↗MalfunctionFeb 13, 2020Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM ONCE AND A NO DELIVERY ALARM DURING BOLUS. CUSTOMER REPORTS THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. 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 9704383 ↗MalfunctionFeb 2, 2020Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR MOTOR POSITION ENCODER ERROR ALARM, AIR BUBBLES, LEAKS AND RIGID SITES OF APPLICATION. CUSTOMER STATED THAT THE CANNULA WAS NOT BENT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL, INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED THAT THE ALARM HISTORY WAS REVIEWED AND THERE WAS MORE THAN ONE MOTOR ERROR ALARM WITHIN 30 DAYS. CUSTOMER ALSO EXPERIENCED HIGH BLOOD GLUCOSE AND IT WAS TREATED WITH SYRINGES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9657033 ↗InjuryJan 12, 2020No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem
CUSTOMER AND DIABETES EDUCATOR REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE LEVEL OF 500 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THERE WAS CRACK NEAR THE UPPER SCREEN EXTENDING TO THE BATTERY COMPARTMENT AND A CRACK NEAR THE ESC BUTTON THAT EXTENDS TOWARDS THE RESERVOIR COMPARTMENT. CUSTOMER STATED THAT THEIR WAS NO PHYSICAL DAMAGE TO RESERVOIR LIP RING. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS WHILE THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9579708 ↗MalfunctionJan 3, 2020Failure to Cycle; Failure to Cycle
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. THE INSULIN PUMP WAS NOT DROPPED OR BUMPED. THE CUSTOMER WAS ADVISED THAT TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9542202 ↗MalfunctionNov 5, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
IT WAS REPORTED THAT INSULIN PUMP HAD UNRESPONSIVE KEYPAD. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9280847 ↗MalfunctionOct 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSULIN PUMP HAD LOOSE DRIVE SUPPORT CAP. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 125MG/DL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9249421 ↗MalfunctionOct 10, 2019Display or Visual Feedback Problem; Mechanical Problem; Use of Device Problem; Power Problem; No Apparent Adverse Event; Display or Visual Feedback Problem; Mechanical Problem; Use of Device Problem; Power Problem; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERRORS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. IT WAS REPORTED THAT THE INSULIN PUMP HAD RAINBOW EFFECT ON THE SCREEN AND WAS REJECTING NEW BATTERIES. THE INSULIN PUMP HAD LOST THE INSULIN PUMP SETTINGS. IT WAS REPORTED THAT THE CLOCK NEEDED TO BE REPROGRAMMED AND THE BACKLIGHT WAS PRETTY DIM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9173894 ↗MalfunctionAug 28, 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 THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT ACT AND ESCAPE BUTTONS OF INSULIN PUMP WAS HARDER TO PRESS AND MORE IN ORDER TO RESPOND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8938851 ↗MalfunctionAug 26, 2019Obstruction of Flow; Connection Problem; Power Problem; Patient Device Interaction Problem; Obstruction of Flow; Connection Problem; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR CAP WAS DAMAGED AND SOMETIMES RESERVOIR WAS NOT SECURE. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP REJECTED NEW BATTERY AS WELL AS HAD CRACKS. THE INSULIN PUMP ALARMED RANDOM NO DELIVERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8929172 ↗InjuryAug 9, 2019Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE VISITED THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE, ON (B)(6) WITH BLOOD GLUCOSE OF 600 MG/DL. THE CUSTOMER WAS TREATED VIA INTRAVENOUS ROUTE. THE CUSTOMER WAS BEING IN HOSPITAL 3 TIMES IN ONE MONTH FOR DIABETES KETOACIDOSIS. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT WITH HIM, IT SAID NO DELIVERY ALL THE TIME. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 8878070 ↗MalfunctionAug 2, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8854476 ↗MalfunctionAug 2, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE ACT BUTTON OF INSULIN PUMP WAS NOT WORKING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT INSULIN PUMP WAS NOT BUMPED, DROPPED OR EXPOSED TO MOISTURE. THE DEVICE WILL BE RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8854042 ↗MalfunctionAug 2, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATED THAT INSULIN PUMP HAD NOT BEEN EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER STATED THAT THEY THE ALARM HISTORY WAS REVIEWED AND THERE WAS MORE THAN ONE MOTOR ERROR ALARM WITHIN ANY 30 DAYS PRESENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8853995 ↗MalfunctionJul 22, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE INSULIN PUMP HAD DAMAGED AT THE BATTERY COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 196 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8814589 ↗MalfunctionJul 18, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD RECEIVED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A BUTTON ERROR ALARM DURING NORMAL USE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8801774 ↗MalfunctionJul 18, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY AND THE ESC AND ACT BUTTONS WERE UNRESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. NO TROUBLESHOOTING WAS PERFORMED. INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8801758 ↗MalfunctionMay 28, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND THE DRIVE SUPPORT CAP WAS LOOS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 80 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. 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 8644978 ↗MalfunctionMay 8, 2019Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE UNEXPECTED RESTART. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8590355 ↗InjuryApr 15, 2019Excess Flow or Over-Infusion; No Apparent Adverse Event; Excess Flow or Over-Infusion; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS 30 MG/DL AT THE TIME OF INCIDENT. THE CURRENT BLOOD GLUCOSE LEVEL IS 79 MG/DL, 52 MG/DL, 47 MG/DL. THE CUSTOMER TREATED LOW BLOOD GLUCOSE WITH FOOD AND ORANGE JUICE. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. BASED ON CUSTOMER¿S REPORT CUSTOMER ALLEGING OVER DELIVERY. THE CUSTOMER WAS WEARING THE INSULIN PUMP WHEN LOW BLOOD GLUCOSE EVENT WAS REPORTED. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8513378 ↗MalfunctionApr 15, 2019No Display/Image; No Display/Image
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD TURNED OFF AND THE CUSTOMER WAS NOT ABLE TO TURN IT ON. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 186 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER HAD CHANGED THE BATTERY BUT THE PROBLEM PERSISTED. 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 8512971 ↗MalfunctionApr 10, 2019No Display/Image; No Display/Image
IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 186 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER DECLINED SIGNS OF PHYSICAL DAMAGE AND SHE SAID THAT PUMP WAS NOT BUMPED, DROPPED OR EXPOSED TO MOISTURE. BATTERY CONTACTS AND CAP WERE OK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8498634 ↗InjuryMar 14, 2019Device Difficult to Program or Calibrate; No Apparent Adverse Event; Device Difficult to Program or Calibrate; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS ON (B)(6) 2019 WITH AN UNKNOWN BLOOD GLUCOSE VALUE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH INSULIN DRIP DURING HOSPITALIZATION. CUSTOMER STATED THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER ALSO STATED THAT THEY WERE UNABLE TO CLEAR THE ALARM. THE CUSTOMER REPORTED THAT THE ESC AND ACT BUTTONS ARE NOT RESPONDING. CUSTOMER STATED THAT THEY WERE REMOVED FROM THE INSULIN PUMP WHEN WENT TO THE HOSPITAL FOR A SEPARATE REASON AND ENDED UP HAVING HIGH BLOOD GLUCOSE VALUES AND DIABETIC KETOACIDOSIS WHILE IN THE HOSPITAL. CUSTOMER DECLINED TO PERFORM A CARELINK UPLOAD. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 8419630 ↗MalfunctionMar 3, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE INSULIN PUMP HAD UNRESPONSIVE KEYPAD. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS PERFORMED. TIME CLOCK ADVANCED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8385051 ↗MalfunctionFeb 15, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD RECEIVED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A BUTTON ERROR ALARM DURING NORMAL USE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345854 ↗
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-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-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Z-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- 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-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-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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