PARADIGM® REAL-time MMT-722NAP (UDI 00613994402028)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-722NAP 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 is a Medtronic MiniMed Paradigm insulin pump that delivers insulin continuously through a catheter. The 42 reports mostly describe the pump failing to deliver insulin, error messages and alarms that did not sound, cracked screens and reservoir compartments, and buttons becoming hard to press. Eight reports describe injuries involving blood sugar swings — high blood sugar, low blood sugar, or diabetic ketoacidosis — with no deaths. 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
- 42
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00613994402028), received between May 31, 2017 and Jun 30, 2020 — classified as 8 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (9 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 Message9
- Detachment of Device or Device Component7
- Failure to Cycle7
- Mechanical Problem6
- Patient Device Interaction Problem5
- Adverse Event Without Identified Device or Use Problem4
- Material Protrusion/Extrusion4
- No Display/Image4
Patient problems
- No Consequences Or Impact To Patient31
- Hyperglycemia8
- Hypoglycemia3
- Anxiety1
- Elevated Ketones/ Diabetic Ketoacidosis1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DEVICE WAS SQUIRTING INSULIN OUT DURING MANUAL PRIME PROCESS. THE DEVICE WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM AND THE DRIVE SUPPORT CAP WAS NOT NORMAL. 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 10211211 ↗MalfunctionJun 22, 2020Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON THE INSULIN PUMP WERE HARD TO PRESS. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. 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 10177632 ↗MalfunctionApr 9, 2020Failure to Cycle; Failure to Cycle
CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 150 MG/DL. TROUBLESHOOTING WAS NOT PERFORMED. THE CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM AND WAS ABLE TO COMPLETE REWIND. THE INSULIN PUMP WILL BE RETURNING FOR ANALYSIS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9946837 ↗MalfunctionFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Power Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Power Problem; Appropriate Device Problem Term/Code Not Available
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BATTERY RANDOMLY SHUTS OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP REJECTS NEW BATTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9710182 ↗InjuryJan 21, 2020No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 50 MG/DL. THE CUSTOMER STATED THE INSULIN PUMP HAD CRACK ON SCREEN AND RESERVOIR COMPARTMENT AND RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. IT WAS UNKNOWN HOW THE CUSTOMER TREATED FOR THEIR LOW. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE LOW BLOOD GLUCOSE 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 9614299 ↗MalfunctionDec 2, 2019Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATES THE INSULIN DID NOT EXIT AND PUMP ALARMED NO DELIVERY. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Anxiety
MAUDE report 9393569 ↗MalfunctionOct 4, 2019Failure to Cycle; Mechanical Problem; Detachment of Device or Device Component; Failure to Cycle; Mechanical Problem; Detachment of Device or Device Component
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE TAKING INSULIN AND THE INSULIN PUMP BEEPED SUBSEQUENTLY FOR A MOTOR ERROR ALARM AND A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 238 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT 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 DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9154944 ↗InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE. THE CUSTOMER CANT REMEMBER MUCH DETAILS WHEN SHE EXPERIENCED DIABETIC KETOACIDOSIS. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH INSULIN PUMP. THE CUSTOMER STATED THAT SHE WAS USING INSULIN PUMP WHILE SHE EXPERIENCED DIABETIC KETOACIDOSIS. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS. UNOMED INF SET, FRN-UNK-RSVR.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 8979401 ↗MalfunctionAug 6, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component
HE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE BLOOD GLUCOSE WAS 295 MG/DL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. ADVISED CUSTOMER TO REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. DEVICE WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8863430 ↗MalfunctionMay 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DRIVE SUPPORT CAP WAS LOOSED. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF INCIDENT. NO FURTHER TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8643375 ↗MalfunctionMay 18, 2019No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE DISPLAY WENT BLANK IMMEDIATELY AFTER INSULIN PUMP EXPOSURE TO MOISTURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING STEPS WERE PROVIDED FOR INSULIN PUMP EXPOSE TO MOISTURE. 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 8622264 ↗InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW AS WELL AS HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 44 YESTERDAY AND AT MORNING IT WAS 428 MG/DL. CUSTOMER STATED THAT THE CANNULA WAS BENT AT THE INFUSION SET. THE CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING HIGH BLOOD GLUCOSE. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 8606708 ↗MalfunctionMay 2, 2019Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERRORS MORE THAN ONCE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATE THAT INSULIN PUMP HAD REJECTED NEW BATTERY AND HAIRLINE FRACTURE WHERE THE RESERVOIR GOES AND ALSO STATE THAT RESERVOIR HAD BEEN LOOSE BUT NEVER FALLEN OUT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573034 ↗MalfunctionApr 15, 2019Mechanical Problem; Power Problem; No Apparent Adverse Event; Patient Device Interaction Problem; Mechanical Problem; Power Problem; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD MOTOR ERROR AND PLASTIC CHIPPED OFF THE INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE WAS 121 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER REPORTS THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER DID NOT REPORT MOTOR POSITION ENCODER ERROR. THE CUSTOMER REPORTS THAT RESERVOIR WAS ABLE TO LOCKED INTO THE 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. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8513608 ↗MalfunctionMar 29, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN HAD RECEIVED MISSING PIECE ON BOTTOM INSULIN PUMP AS WELL AS BUTTONS STICK AND NO DELIVERY ALARMS WITH INSULIN STILL IN THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE BACK LIGHT GOES OFF AND LOSES SETTING ON THE INSULIN PUMP WHEN CHANGES BATTERY. TROUBLESHOOTING WAS NOT PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8464062 ↗MalfunctionMar 13, 2019Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 201 MG/DL. CUSTOMER SATED THEY WERE ABLE TO CLEAR THE ALARM HOWEVER NOT ABLE TO COMPLETE REWIND. 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 8415369 ↗MalfunctionFeb 24, 2019Obstruction of Flow; Moisture or Humidity Problem; Obstruction of Flow; Moisture or Humidity Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BATTERY LIFE DOES NOT LAST AS LONG AS WHEN INSULIN PUMP WAS NEW. THE BLOOD GLUCOSE WAS UNKNOWN. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8365065 ↗MalfunctionFeb 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DRIVE SUPPORT CAP OF THE INSULIN PUMP WAS LOOSE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED 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 THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8305175 ↗MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DRIVE SUPPORT CAP OF THE INSULIN PUMP WAS LOOSE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8296038 ↗MalfunctionDec 24, 2018Date/Time-Related Software Problem; Patient Device Interaction Problem; Priming Problem; Date/Time-Related Software Problem; Patient Device Interaction Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THE RESET DATE AND TIME ON INSULIN PUMP EVERY TIME SHE CHANGES BATTERY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. INSULIN PUMP WAS MAKING STRANGE NOISE WHEN PRIMING AFTER REPLACING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8193549 ↗InjuryNov 14, 2018Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. CUSTOMER ADVISED THEY WERE CHANGING THE INFUSION SET WHEN THE ALARM OCCURRED. 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 8068227 ↗MalfunctionOct 15, 2018Failure to Cycle; Failure to Cycle
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 208 MG/DL. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER NOT ABLE TO COMPLETE 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 INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7964338 ↗InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS ADMITTED TO HOSPITAL TWO TIMES DUE TO DIABETIC KETOACIDOSIS ON (B)(6) 2018 AT 12:30 PM AND ON (B)(6) 2018 AT 3:30 PM WITH BLOOD GLUCOSE OF 407 AND 377 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE IS 297 MG/DL. THE CUSTOMER DID EXPERIENCED THE SYMPTOMS SUCH AS NAUSEA, VOMITING, ABDOMINAL PAIN AND DIFFICULTY BREATHING. TROUBLESHOOTING WAS DONE. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7933308 ↗MalfunctionAug 23, 2018Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS ABLE TO COMPLETE THE REWIND PROCESS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE 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 7808923 ↗MalfunctionAug 10, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SEVERAL ISSUES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP BUTTONS WERE STICKING AND UNRESPONSIVE, AND THE RESERVOIR WOULD NOT LOCK IN THE RESERVOIR COMPARTMENT. CUSTOMER DECLINED TROUBLESHOOTING. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7773810 ↗
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-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-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- Z-1593-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- 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-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- 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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