PARADIGM® REAL-time MMT-522LNAS (UDI 00613994407696)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-522LNAS PRDGM INS V2.4 SK EN LK · Class 3
Quick summary
This Medtronic Paradigm REAL-time insulin pump has 131 reports, many describing incorrect messages, reservoirs that do not lock in place and insulin delivery problems such as squirting or missed delivery alarms. The reports mention 3 deaths and 31 injuries, many involving high blood sugar, and 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
- 131
- Deaths reported
- 3
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 00613994407696), received between Jun 1, 2017 and Oct 16, 2020 — classified as 3 deaths, 31 injuries, 97 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (23 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Displays Incorrect Message23
- Patient Device Interaction Problem22
- Device Difficult to Program or Calibrate12
- Mechanical Problem12
- Adverse Event Without Identified Device or Use Problem9
- No Display/Image8
- Priming Problem8
- Device Operates Differently Than Expected7
Patient problems
- No Consequences Or Impact To Patient87
- Hyperglycemia38
- Hypoglycemia8
- Death3
- Elevated Ketones/ Diabetic Ketoacidosis1
Recent adverse event reports
The 25 most recent of 131 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEIR INSULIN PUMP HAD MOTOR ERROR ALARM AND NO DELIVERY ALARMS. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID NOT RECEIVE MOTOR POSITION ENCODER ALARM. CUSTOMER STATED THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO COMPLETE REWIND THE INSULIN PUMP. 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 10688445 ↗MalfunctionAug 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S LIP RING WAS BROKEN. THE CUSTOMER STATED THAT THE RESERVOIR WAS UNABLE TO LOCK INTO PLACE. THE INSULIN PUMP HAD COSMETIC DAMAGE. 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 10391157 ↗DeathJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN AN UNKNOWN LOCATION. THE CAUSE OF DEATH WAS SEVERE BRAIN INJURY DUE TO A HYPOGLYCEMIC EPISODE. THE CALLER DID NOT STATE WHETHER THE CUSTOMER HAD ANY OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMERS BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. NO FURTHER INFORMATION WAS PROVIDED. THE CALLER DID NOT STATE WHETHER THEY WOULD RETURN THE INSULIN PUMP FOR ANALYSIS.
Patient problems: Death; Hypoglycemia
MAUDE report 10306391 ↗MalfunctionJun 25, 2020Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD POSSIBLE REWIND ANOMALY. THE CUSTOMER ALSO STATED THAT, THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN, MISSING RESERVOIR COMPARTMENT AND BUTTON PAD DETACHED AND NO DELIVERY ALARMS DURING PRIMING PROCESS. 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 10193862 ↗MalfunctionApr 8, 2020Excess Flow or Over-Infusion; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Battery Problem; Connection Problem; Power Problem; Patient Device Interaction Problem; Excess Flow or Over-Infusion; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Battery Problem; Connection Problem; Power Problem; Patient Device Interaction Problem
THE INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PIECE OF PLASTIC MISSING OFF THE RESERVOIR COMPARTMENT AND BLACK O-RING WAS MISSING. THE CUSTOMER REPORTED THAT RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. IT WAS REPORTED THAT THE INSULIN PUMP HAD FAILED BATTERY TEST, BUTTONS WERE HARDER TO PRESS, RESERVOIR CAP BROKEN AND SOMETIMES FALLS OUT, RANDOM NO DELIVERY ALARM AND INSULIN PUMP NOT GIVING THE CORRECT AMOUNT OF INSULIN. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9941200 ↗MalfunctionMar 5, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PLASTIC CHIPPED AWAY AT TOP OF THE RESERVOIR COMPARTMENT. TROUBLESHOOTING WAS DONE FOR COSMETIC DAMAGE. THE CUSTOMER STATED THAT THE RESERVOIR DID LOCK INTO PLACE. 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 9791581 ↗MalfunctionJan 20, 2020Failure to Cycle; Failure to Cycle
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 9609312 ↗InjuryJan 17, 2020Connection Problem; Connection Problem
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE WITH UNKNOWN BLOOD GLUCOSE LEVELS AT THE TIME OF THE INCIDENT. 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 AND AS THE CUSTOMER DECLINED AS THEY STATED THE LOW WAS NOT CAUSED BY A PUMP ISSUE. THE CUSTOMER REPORTED PUMP PHYSICAL DAMAGE AND A RESERVOIR THAT COULD NOT LOCK INTO THE PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS ON THIS CASE.
Patient problems: Hypoglycemia
MAUDE report 9600175 ↗MalfunctionJan 17, 2020Failure 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 UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED OR BUMPED PRIOR TO THE ALARM OCCURRING. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED 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: No Consequences Or Impact To Patient
MAUDE report 9599855 ↗MalfunctionDec 16, 2019Device Alarm System; Connection Problem; Patient Device Interaction Problem; Device Alarm System; Connection Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE END OF INSULIN PUMP WAS BROKEN AND RESERVOIR WAS NOT KEEPING IN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE INSULIN PUMP WAS NOT GIVING ALERT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9473963 ↗MalfunctionDec 16, 2019Display or Visual Feedback Problem; Power Problem; Insufficient Device Problem Information; Display or Visual Feedback Problem; Power Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD RANDOM ALARMS WITH NO REASON. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT INSULIN PUMP HAD REJECTED NEW BATTERIES AND NO BACKLIGHT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9472108 ↗MalfunctionDec 3, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR AND HAD A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 172 MG/DL. THE CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM BUT UNABLE TO REWIND THE INSULIN PUMP. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9399712 ↗MalfunctionNov 14, 2019Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 130 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM AND 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 9321636 ↗MalfunctionNov 12, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR WHILE TRYING TO CHANGE RESERVOIR. THE CUSTOMER DECLINED TO PROVIDE THEIR BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THEY WANTED TO USE A NEW INSULIN PUMP THAT THEY HAD AND THE TROUBLESHOOTING WAS NOT FULLY PERFORMED. THERE WAS NO INDICATION OF THE ISSUE BEING RESOLVED DURING THE CALL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9308971 ↗MalfunctionOct 1, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9138183 ↗MalfunctionSep 30, 2019Device Alarm System; Power Problem; Device Alarm System; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP FAILED TO GIVE NO DELIVERY ALARM WHILE THERE WAS NO INSULIN IN RESERVOIR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. INSULIN PUMP HAD REJECTED NEW BATTERY ALARM. IT WAS UNKNOWN THAT THE INSULIN PUMP WILL BE RETURNED OR NOT FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9137938 ↗InjurySep 24, 2019Detachment of Device or Device Component; No Apparent Adverse Event; Patient Device Interaction Problem; Detachment of Device or Device Component; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS DAMAGED AT THE BOTTOM. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS DAMAGE AND IT WAS STICKING OUT. CUSTOMER WAS ADVICE TO TREAT AS PER THEIR HEALTH CARE PROFESSIONAL¿S ADVICE. CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9107997 ↗MalfunctionSep 13, 2019Priming Problem; Priming Problem
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME PROCESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 162 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATES THEY WERE NOT ABLE TO EXIT ABLE TO PREPARING TO PRIME LOOP. CUSTOMER STATED THAT THEY WERE STUCK IN REWIND PROCESS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9031551 ↗MalfunctionSep 11, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 172 MG/DL. THE CUSTOMER WAS BLOUSING AND PUSHING THE UP ARROW AND IT WOULD NOT STOP. THE INSULIN PUMP HAD BATTERY OUT LIMIT. THE TIME CLOCK WAS ADVANCES. CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8987414 ↗MalfunctionJul 24, 2019Mechanical Problem; Obstruction of Flow; Detachment of Device or Device Component; Device Markings/Labelling Problem; Priming Problem; Mechanical Problem; Obstruction of Flow; Detachment of Device or Device Component; Device Markings/Labelling Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND DRIVE SUPPORT CAP WAS INDENTED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 240 MG/DL. THE CUSTOMER STATED THAT THE NO DELIVERY ALARM OCCURRED DURING NORMAL USE. CUSTOMER RAN SELF TEST AND DISPLACEMENT TEST AND BOTH WERE PASSED. CUSTOMER REPORTED THAT THE NO DELIVERY ALARM WAS RESOLVED BY RESERVOIR CHANGED. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. 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 8821169 ↗MalfunctionJul 22, 2019Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL 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 THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER STATED EVERY TIME THEY PRIME THE INSULIN PUMP REBOOT AND REQUIRES ANOTHER REWIND AND PRIME. 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 8810547 ↗MalfunctionJul 12, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8783568 ↗MalfunctionJul 11, 2019Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT WHEN THEY CHANGING THERE RESERVOIR A PIECE OF PLASTIC CHIPPING OFF. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT INSULIN PUMP HAD REJECT NEW BATTERY AND HAD A RAINBOW EFFECT ON SCREEN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP MAKES UNUSUAL GRINDING NOISES AS WELL AS IT WAS REWIND SLOWER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8779903 ↗MalfunctionJul 1, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8747570 ↗MalfunctionJul 1, 2019Mechanical Problem; Mechanical Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 230 MG/DL. CUSTOMER ALSO STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM AND 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 DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8747260 ↗
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-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- 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-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-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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.