PARADIGM® REAL-time MMT-722NAS (UDI 00613994622556)Recalls & reported problems

Summary

The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00613994622556), received between Jun 6, 2017 and Jul 21, 2020 — classified as 1 death, 32 injuries, 175 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (46 reports).

1 FDA recall record name this device's identifier, 1 still open.

13 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.

Recalls naming this device

1. Feb 13, 2026Class IIOpen, Classified

   All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

   Z-1749-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 208 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN WAS DROPPING AFTER MOTOR STOPPED DURING FILL MANUAL PROCESS. CUSTOMER WAS ON STUCK ON PREPARING TO FILL CYCLE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10300771 ↗
• MalfunctionJul 6, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DRIVE 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 10231349 ↗
• MalfunctionJun 26, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER NOT ABLE TO COMPLETE 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 10199304 ↗
• MalfunctionMay 18, 2020Device Alarm System; Moisture or Humidity Problem; Device Alarm System; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP GOT FILLED WITH INSULIN INSIDE THE RESERVOIR BARREL. CUSTOMER STATED THE INSULIN PUMP WAS VIBRATED WITHOUT AN ALARM OR ALERT. CUSTOMER STATED A CONSTANT TONE WAS OCCURRED. 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 10065238 ↗
• MalfunctionMay 8, 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 COMPROMISED FORCE SENSOR SYSTEM ALARM DURING SEATING THE FORCE SENSOR DID NOT DETECT THE RESERVOIR. IT WAS REPORTED THAT THE CUSTOMER WAS TREATED MANUALLY. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS LOOSE. CUSTOMER STATES INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. 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 10037604 ↗
• MalfunctionApr 30, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED 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 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 10013037 ↗
• MalfunctionApr 1, 2020Failure to Cycle; Display or Visual Feedback Problem; Failure to Cycle; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM AND INSULIN PUMP WAS SHOWING A BLACK CIRCLE. THE CUSTOMER STATED THE INSULIN PUMP WAS REWINDED AND THEN PRIME. THE DEVICE WAS NOT BUMPED OR DROPPED PRIOR TO THE COMPROMISED FORCE SENSOR SYSTEM ALARM AND THE DRIVE SUPPORT CAP APPEARS 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 9913342 ↗
• MalfunctionMar 24, 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 COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THEY WERE STUCK IN REWIND LOOP. DIVE SUPPORT CAP WAS STICKING OUT. 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 9870884 ↗
• MalfunctionMar 13, 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 COMPROMISED FORCE SENSOR SYSTEM ALARM AND DRIVE SUPPORT CAP WAS PROTRUDED. 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 9827805 ↗
• MalfunctionFeb 17, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER STATED THAT TIME WAS ADVANCING. 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 9716162 ↗
• MalfunctionFeb 10, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE NOT ABLE TO REWIND 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 9685484 ↗
• MalfunctionFeb 3, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT BUTTON WOULD STICK SOMETIMES. THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALERTS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9658453 ↗
• MalfunctionJan 16, 2020Premature Discharge of Battery; Premature Discharge of Battery

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PUMP ERROR ALARM AFTER INSERTING A NEW BATTERY. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM ALSO ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED THE INSULIN PUMP WAS NOT STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. CUSTOMER HAD EXPERIENCED MULTIPLE PUMP ERROR ALARMS AFTER BATTERY CHANGE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595091 ↗
• MalfunctionJan 13, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE INSULIN PUMP HAD BUTTONS WERE NOT RESPONDING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED. CUSTOMER CHANGED THE BATTERY, THE INSULIN PUMP TURNED ON AND THE TIME ADVANCES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS UNTIL REPLACEMENT ARRIVES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9584475 ↗
• MalfunctionJan 10, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE CUSTOMER'S ACT BUTTON WAS NOT WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 140 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED, BUMPED OR EXPOSED TO MOISTURE. CUSTOMER STATED THAT THE TIME WAS ADVANCING NORMALLY. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9573912 ↗
• MalfunctionDec 30, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Unspecified Infection

  MAUDE report 9529302 ↗
• MalfunctionDec 20, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9502595 ↗
• MalfunctionDec 17, 2019Priming Problem; Priming Problem

  IT WAS REPORTED THAT THE INSULIN CONTINUED DRIPPING AFTER LETTING GO OF THE ACT BUTTON AND INSULIN SQUIRTED OUT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. 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 9478636 ↗
• MalfunctionDec 4, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. A COLD RESET WAS PERFORMED. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THE DEVICE WAS NOT WORKING HE CANNOT GO THROUGH THE PRIMING PROCESS AND HE DID CHANGE THE ENTIRE SET TODAY AND IT RESET THE DEVICE AND STILL THE DOT ON THE RESERVOIR IS STILL NOT WORKING. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER REPORTED INSULIN PUMP DID REQUIRE REWIND. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9408301 ↗
• MalfunctionNov 29, 2019Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CHIPPING AT THE INSULIN RESERVOIR AND UNEXPLAINED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP SCREEN WAS INDENTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9390851 ↗
• MalfunctionNov 28, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND THERE WAS WEAR ON THE ACT AND ESC BUTTONS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE BATTERY COMPARTMENT OPENING WITH THE THREADS WAS COMPLETELY BROKEN OFF THE INSULIN PUMP AND BATTERY LIFE DIMINISHED DOWN TO 3 TO 4 DAYS. CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD REJECTED NEW BATTERIES, MULTIPLE RANDOM NO DELIVERY ALARM AND REWINDS LOUDER THAN BEFORE. CUSTOMER DECLINED TO TROUBLESHOOTING WITH TECHNICAL SUPPORT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9389419 ↗
• MalfunctionNov 27, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9382163 ↗
• MalfunctionNov 18, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT ESC BUTTONS WERE NOT WORKING AS EXPECTED AND HAD UNEXPECTED RESTART. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 74 MG/DL AT THE TIME OF INCIDENT. TIME CLOCK ADVANCED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9334155 ↗
• MalfunctionNov 14, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RANDOM UNEXPLAINED NO DELIVERY ALARMS, BUTTONS WERE HARDER TO PUSH AND WERE NON RESPONSIVE, THE INSULIN PUMP WAS SLOWER TO REWIND, THE INSULIN PUMP SOMETIMES STOPPED DURING REWIND AND HAD DIMINISHED BATTERY LIFE AND PUMP SCREEN WAS REALLY DIFFICULT TO SEE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325540 ↗
• MalfunctionNov 12, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 97 MG/DL. CUSTOMER REPORTED THAT THE ARROW DOWN BUTTON WAS STUCK UP AND NUMBERS WERE NOT RAMPING ON THEIR OWN ALSO THAT THE SCROLL BAR WAS NOT MOVING WITH NO INPUT. CUSTOMER STATED THAT THERE WAS NO RESPONSE FROM ANY BUTTON. 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 9308306 ↗

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-1256-2025 · Jan 31, 2025 · Open, Classified
  Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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