PARADIGM® REAL-time MMT-722NAL (UDI 00643169478534)Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 00643169478534), received between Jun 1, 2017 and Aug 23, 2020 — classified as 25 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (20 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

Recent adverse event reports

The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2020No Display/Image; Battery Problem; Patient Device Interaction Problem; No Display/Image; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A LOW BATTERY ALERT AND SHE WAS CHANGED INSULIN PUMP BATTERY AND INSULIN PUMP DOES NOT TURNED ON. CUSTOMER STATED THAT THERE WAS CRACK NEXT TO BATTERY CAP. 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 10440662 ↗
• MalfunctionAug 12, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE NOT RESPONDING TO COMMAND WHEN PRESSED. CUSTOMER CONFIRMED THAT THE TIME CLOCK WAS ADVANCING. 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 10395760 ↗
• MalfunctionJul 23, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM WHEN PRIMING IT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. INSULIN DELIVERY HAS TEMPORARILY STOPPED TO ENSURE YOUR SAFETY. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS UNABLE TO CLEAR ALARM AND PUMP REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313648 ↗
• MalfunctionMay 27, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM AFTER BATTERY CHANGE. CUSTOMER STATED THEY WERE UNABLE TO REWIND 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 10090600 ↗
• MalfunctionMay 26, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION INDICATED BY MEDTRONIC THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE DEVICE WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM AND THE DRIVE SUPPORT CAP APPEARS LOOSE. NO FURTHER DETAILS GIVEN. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. 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 10086389 ↗
• MalfunctionMay 8, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP DID NOT TURN ON. CUSTOMER REPORTED PHYSICAL DAMAGE TO THE INSULIN PUMP. 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 10037393 ↗
• MalfunctionApr 9, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD FAILURES IN THE DISPLAY. TROUBLESHOOTING WAS PERFORMED. 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 9942307 ↗
• MalfunctionApr 9, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED. CUSTOMER HAD CHANGED THE BATTERY AND ISSUE PERSISTED. CUSTOMER STATED THAT INSULIN PUMP WAS NOT BUMPED, DROPPED OR EXPOSED TO MOISTURE AND DECLINED SIGNS OF PHYSICAL DAMAGE. BATTERY CONTACTS CAP AND COMPARTMENT WERE OK, NOT DAMAGED, MISSING OR CORRODED. 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 9942198 ↗
• MalfunctionMar 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WERE NOT RESPONDING. THE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER OBSERVED TIME CLOCK FOR ONE MINUTE AND FOUND THAT THE TIME WAS ADVANCING. 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 9797124 ↗
• MalfunctionMar 4, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BATTERY COMPARTMENT WAS BROKEN. NO FURTHER DETAILS GIVEN. 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 9784474 ↗
• MalfunctionFeb 7, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THEY WERE STUCK IN REWIND LOOP. DIVE SUPPORT CAP WAS NORMAL. 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 9679890 ↗
• MalfunctionJan 12, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE INSULIN PUMP HAD PUMP ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT INSULIN PUMP RECENTLY WAS NOT STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. CUSTOMER STATED THAT ALARM WAS OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9579397 ↗
• MalfunctionJan 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DRIVE SUPPORT CAP HAS CAME LOOSE AT THE MOMENT WHEN SHE WAS CHANGING THE INFUSION SET. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 200 MG/DL. THE INSULIN BEGAN TO LEAK THROUGH THE DRIVE SUPPORT CAP. 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 9556167 ↗
• MalfunctionDec 17, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE INSULIN PUMP HAD BLANK DISPLAY AT BATTERY CHANGE MOMENT. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP ARE NEITHER MISSING NOR DAMAGED. CUSTOMER ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO FURTHER DETAIL GIVEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9478620 ↗
• MalfunctionDec 8, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INSULIN PUMP HAD A MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 215 MG/DL. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD AND THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO COMPLETE THE REWIND PROCESS. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9435280 ↗
• MalfunctionNov 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 RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM DURING CONSUMABLES CHANGE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 219 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS LOOSE AND SHE FIXED IT USING GLUE AS WELL AS NOT ABLE TO EXIT FROM REWIND PROCESS. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9388166 ↗
• MalfunctionNov 16, 2019Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 292 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT BUMPED OR DROPPED. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9333081 ↗
• MalfunctionNov 14, 2019Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150 MG/DL. THE CUSTOMER ALSO REPORTED THAT INSULIN SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT THE INSULIN PUMP WAS DROPPED. CUSTOMER TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED, 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 9320576 ↗
• MalfunctionOct 17, 2019No Display/Image; No Display/Image

  CUSTOMER REPORTED THAT PUMP ALARMED LOW BATTERY, HE CHANGED THE BATTERY AND PUMP DID NOT TURN ON. CUSTOMER REPORTED THAT PUMP WAS NOT BUMPED, DROPPED OR EXPOSED TO MOISTURE.. CUSTOMER USED ENERGIZER BATTERY. CUSTOMER REMOVED THE BATTERY, CLEANED THE BATTERY CONTACTS CAP AND COMPARTMENT WITH A COTTON SWAB AND INSERTED A NEW BATTERY. PUMP DID NOT TURN ON. PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9200874 ↗
• MalfunctionSep 30, 2019Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  IT WAS REPORTED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 109 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THERE WAS MORE THAN ONE MOTOR ERROR ALARM WITHIN 30 DAYS PRESENT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9133467 ↗
• MalfunctionSep 22, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THEY PERFORMED DISPLACEMENT TEST AND FIXED PRIME OF 5 UNITS AND BOTH WERE OKAY. THE CUSTOMER ALSO REPORTED THAT THE MOTOR CAP WAS NORMAL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9101422 ↗
• MalfunctionSep 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP BUTTONS DOES NOT WORK. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9097264 ↗
• MalfunctionSep 20, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT 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. THE INSULIN PUMP IS BEING REPLACED AND IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9097118 ↗
• MalfunctionSep 19, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER WILL CALL BACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9085560 ↗
• MalfunctionAug 21, 2019Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Moisture or Humidity Problem

  IT WAS REPORTED THAT THE INSULIN PUMP ALL THE BUTTONS WERE NOT RESPONDING AND HAD FROZEN DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD UNEXPECTED RESTART ALARM AND THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER WERE UNABLE TO COMPLETE TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8919284 ↗

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, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• Z-1256-2025 · Jan 31, 2025 · Open, Classified
  Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-2442-2015 · Jul 22, 2015 · Terminated
  Guardian 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 · Terminated
  Medtronic 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 · Terminated
  Medtronic 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