PARADIGM® REAL-time MMT-722NAS (UDI 00643169478558)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00643169478558), received between May 26, 2017 and Jul 22, 2020 — classified as 7 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED MOTOR ERROR ALARMS. INSULIN PUMP WAS LOUD DURING REWIND. CUSTOMER ALSO REPORTED NO POWER MOTOR ERRORS EVEN THOUGH THE BATTERY WAS NEW. 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 10306700 ↗
• MalfunctionJul 13, 2020Mechanical Problem; Intermittent Communication Failure; Mechanical Problem; Intermittent Communication Failure

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARMS. CUSTOMER WAS ASSISTED WITH CLEARING THE ALARM. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10262817 ↗
• MalfunctionJun 18, 2020Application Program Version or Upgrade Problem; Application Program Version or Upgrade Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A INSULIN PUMP 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 10166733 ↗
• MalfunctionJun 4, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED MOTOR POSITION ENCODED ERROR ALARM AND OTHER PUMP ERROR ALARM. CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND CUSTOMER REWOUND THE INSULIN PUMP SUCCESSFULLY. IT WAS REPORTED THAT DRIVE SUPPORT CAP WAS NORMAL AND INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC ENVIRONMENT. 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 10117411 ↗
• MalfunctionJun 2, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR AND MOTOR POSITION ENCODER ERROR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10108386 ↗
• MalfunctionMar 4, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED INSULIN PUMP DID NOT ALERT AFTER INSERTING A NEW BATTERY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9784477 ↗
• InjuryMar 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE AS WELL AS THE DRIVE SUPPORT CAP WAS LOOSE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 520 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS EXPERIENCING ABDOMINAL PAIN AND NAUSEA. NO FURTHER DETAILS WERE PROVIDED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Abdominal Pain; Hyperglycemia; Nausea

  MAUDE report 9773511 ↗
• MalfunctionNov 27, 2019Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP WAS NOT ALARMING LOW RESERVOIR. 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 9381193 ↗
• MalfunctionOct 29, 2019No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE BATTERY CONTACTS CAP AND COMPARTMENT WERE NOT DAMAGED, MISSING OR CORRODED. THE DISPLAY DID NOT RETURN ON INSERTING NEW BATTERY. 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: No Consequences Or Impact To Patient

  MAUDE report 9248507 ↗
• MalfunctionSep 19, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND UNABLE TO COMPLETE THE REWIND PROCESS BECAUSE IT ALARMED BUTTON ERROR. INSULIN PUMP IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9085670 ↗
• MalfunctionSep 19, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY AND THE BUTTONS WERE UNRESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE WAS 150 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS NOT BUMPED OR DROPPED. INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9085642 ↗
• MalfunctionJul 22, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 140 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8814601 ↗
• MalfunctionJul 18, 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. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. 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 8801649 ↗
• MalfunctionJul 6, 2019Device Alarm System; Device Difficult to Program or Calibrate; Device Alarm System; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP KEPT BEEPING AND BUTTONS WERE NOT WORKING. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8765767 ↗
• MalfunctionJul 4, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 117 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. CUSTOMER STATED THAT THE CONTACTS ON THE BATTERY CAP ARE NOT MISSING OR DAMAGED. CUSTOMER STATED THAT THE BATTERY COMPARTMENT IS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING IS NEITHER DAMAGED NOR CORRODED. 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: No Consequences Or Impact To Patient

  MAUDE report 8762602 ↗
• MalfunctionMay 16, 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 INSULIN PUMP ALARMED MOTOR ERROR AND UNABLE TO CLEAR THE ALARM. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS NOT 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 8614565 ↗
• MalfunctionMay 3, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INSULIN PUMP HAD CONSECUTIVE MOTOR ERROR ALERTS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL 241 MG/DL. TROUBLESHOOTING WAS PERFORMED. THEY REPORTED THAT THERE WERE MORE THAN ONE MOTOR ERROR ALARM WITHIN 30 DAYS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8576546 ↗
• MalfunctionMar 8, 2019Mechanical Problem; Obstruction of Flow; Detachment of Device or Device Component; Mechanical Problem; Obstruction of Flow; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSULIN PUMP HAD RECEIVED MOTOR ERROR ALARM AS WELL AS DRIVE SUPPORT CAP WAS STICKING OUT AND NO DELIVERY ALARMS. CUSTOMER¿S BLOOD GLUCOSE WAS 223 MG/DL. CUSTOMER STATED THAT THE INSULIN DID EXIT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402978 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON UNKNOWN WITH BLOOD GLUCOSE OF 348 MG/DL. CUSTOMER STATES THAT DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8353129 ↗
• MalfunctionJan 22, 2019Power Problem; Power Problem

  IT WAS REPORTED THAT THE INSULIN PUMP HAD OFF NO POWER WITHOUT ANY ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS NOT PERFORMED FOR POWER LOSS ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266204 ↗
• InjuryDec 13, 2018Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND INSULIN PUMP ALARMED NO DELIVERY DURING MANUAL PRIME. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. THE CUSTOMER ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER CHANGED WHOLE INFUSION SET BUT INSULIN DID NOT EXIT. THE CUSTOMER DID NOT PROVIDE INFORMATION ABOUT SYMPTOMS AND TREATMENT AS A RESULT OF HIGH BLOOD GLUCOSE VALUE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8159216 ↗
• MalfunctionSep 28, 2018Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 217 MG/DL AT THE TIME OF INCIDENT. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS REWINDING THE PUMP AND GET NO RESERVOIR. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT WORKING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7917564 ↗
• MalfunctionSep 6, 2018Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY ALSO THE INSULIN PUMP FAILED BATTERY TEST. THE PATIENT¿S BLOOD GLUCOSE WAS UNKNOWN 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 DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7849876 ↗
• InjuryJun 14, 2018Failure to Deliver; High Test Results; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED TO HIGH BLOOD GLUCOSE LEVEL AS WELL AS INSULIN NO DELIVERY ALARM. THE BLOOD GLUCOSE LEVEL WAS OVER 405 MG/DL. CUSTOMER ALSO STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7600320 ↗
• InjuryJun 4, 2018Material Deformation

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE WITH BLOOD GLUCOSE OF OVER 400 MG/DL AND IT GOT TO 500 MG/DL AND 467 MG/DL, THE CUSTOMER CURRENT BLOOD GLUCOSE WAS 466 MG/DL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2018 MORNING. THE DRIVE SUPPORT CAP APPEARS NORMAL (SLIGHTLY INDENTED). THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS TIREDNESS, CRAMP, PAIN. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7564718 ↗

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, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• Z-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• 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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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