PARADIGM® REAL-time MMT-722NAS (UDI 00613994402011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00613994402011), received between May 8, 2017 and Mar 24, 2022 — classified as 2 deaths, 30 injuries, 176 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (53 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.

• MalfunctionMar 24, 2022Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL CONTINUE TO USE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13890761 ↗
• MalfunctionOct 8, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR. CUSTOMER STATED DRIVE SUPPORT CAP APPEARED NORMAL-SLIGHTLY INDENTED. CUSTOMER STATED THEY WERE ABLE TO SUCCESSFULLY CLEAR THE ALARM AND WERE ABLE TO 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 10653735 ↗
• MalfunctionSep 7, 2020Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS CRACK AROUND THE BATTERY COMPARTMENT AND NEAR RESERVOIR WINDOW. CUSTOMER STATED THAT INSULIN PUMP HAD RANDOM NO DELIVERY ALARM AND REWIND WAS SLOWER THAN IN THE PAST. CUSTOMER ALSO STATED THAT INSULIN SHOOTS OUT OF INFUSION SET. CUSTOMER STATED THAT THERE WAS SCRATCHES ON THE DISPLAY. 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 10500302 ↗
• InjuryAug 20, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING LOW BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 54 MG/DL. CUSTOMER WAS TREATED WITH CARBOHYDRATE. CUSTOMER STATED INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER STATED THEY DID NOT HOLDING A BUTTON DOWN FOR 3 MINUTES OR LONGER. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10435336 ↗
• MalfunctionAug 11, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARMS. THE INSULIN PUMP HAD CRACK ON THE RESERVOIR COMPARTMENT, BATTERY COMPARTMENT, AND FRONT OF THE PUMP NEAR THE DISPLAY SCREEN. THREADS ON THE BATTERY COMPARTMENT CHIPPED. THE INSULIN PUMP HAD COSMETIC DAMAGE. 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 10390255 ↗
• MalfunctionJul 24, 2020Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A LOT OF PROBLEMS AND THE WHOLE BOTTOM OF THE INSULIN PUMP WAS CAME 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 10318508 ↗
• MalfunctionJul 17, 2020Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER DECLINED TROUBLESHOOTING FOR BUTTON ERROR. THE BUTTONS FROM THE KEYPAD HAD COLLAPSED. 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 10287463 ↗
• MalfunctionJun 29, 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 THAT THE DRIVE 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 10206439 ↗
• MalfunctionJun 4, 2020Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERRORS. THE CUSTOMER ALSO REPORTED THAT THEY HAD TO REWOUND AND RE PRIME THE INSULIN PUMP TO WORK. THE INSULIN PUMP WAS COMPLETELY DIED AND UNABLE TO READ IT. 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 10117676 ↗
• MalfunctionMay 26, 2020Failure to Cycle; Mechanical Problem; Detachment of Device or Device Component; Failure to Cycle; Mechanical Problem; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM AS WELL AS MOTOR ERROR ALARM. THE CUSTOMER STATED THE 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 10086080 ↗
• MalfunctionMay 20, 2020No Display/Image; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Insufficient Device Problem Information; No Display/Image; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS DELIVERING MORE INSULIN AT TIMES, AND OTHER TIMES NOT GIVING MUCH INSULIN. CUSTOMER STATED THE INSULIN PUMP WAS NO LONGER WORKING AND RECEIVED ERROR CODES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10073800 ↗
• MalfunctionMay 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTON ON THE INSULIN PUMP HAD BUTTON ERROR ALARM AND BUTTONS WERE NOT RESPONDING. CUSTOMER STATED 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 10031501 ↗
• MalfunctionMay 6, 2020Device Difficult to Program or Calibrate; No Apparent Adverse Event; Device Difficult to Program or Calibrate; No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE STICKING. 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 10028518 ↗
• MalfunctionApr 29, 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 ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER STATED DRIVE SUPPORT CAP WAS STICKING OUT. 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 10008656 ↗
• MalfunctionApr 14, 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 DRIVE 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 9957224 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO HIGH BLOOD GLUCOSE ON ABOUT (B)(6) 2013. THE CUSTOMER WAS UNSURE OF THE SPECIFIC DATE. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD STOPPED PUMPING. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER NO LONGER HAD THE INSULIN PUMP AND STATED WAS PREVIOUSLY RETURNED. THE CUSTOMER ALSO MENTIONED ANOTHER HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2013 THAT REQUIRED HOSPITALIZATION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9909833 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO HIGH BLOOD GLUCOSE ON ABOUT (B)(6) 2013. THE CUSTOMER WAS UNSURE OF THE SPECIFIC DATE. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN AND POSSIBLY MANUAL INJECTIONS. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD STOPPED PUMPING. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER NO LONGER HAD THE INSULIN PUMP AND STATED WAS PREVIOUSLY RETURNED. THE CUSTOMER ALSO MENTIONED ANOTHER HIGH BLOOD GLUCOSE EVENT ON (B)(6) 2013 THAT REQUIRED HOSPITALIZATION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9909136 ↗
• MalfunctionMar 20, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. 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 9859073 ↗
• MalfunctionMar 18, 2020Failure to Cycle; Insufficient Device Problem Information; Failure to Cycle; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM AT THE TIME OF PRIME REWIND. CUSTOMER HAD UNSPECIFIED ALARM. THE CUSTOMER STATED THAT THEY WERE UNABLE TO CLEAR THE 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 9846172 ↗
• MalfunctionMar 17, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT ACT BUTTON HAD TO BE PRESS HARDER OR MULTIPLE TIMES TO ACTIVATE. THE BATTERY WAS DIED WITHOUT LOW BATTERY WARNING. THE INSULIN PUMP HAD COUPLE NO DELIVERY ALERTS. 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 9840947 ↗
• MalfunctionMar 11, 2020Failure to Cycle; Mechanical Problem; Failure to Cycle; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PRIM ANOMALY. CUSTOMER STATED INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THEY WERE STUCK IN REWIND. CUSTOMER STATED THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. 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 9816761 ↗
• MalfunctionMar 4, 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 STICKING OUT. 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 9785112 ↗
• MalfunctionFeb 14, 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 HE WAS RELOADED HIS INSULIN PUMP HE PUT THE RESERVOIR IN AFTER REWOUND WHILE TRYING TO LOAD IT WAS GIVEN HIM COMPROMISED FORCE SENSOR SYSTEM ALERT. 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 9710492 ↗
• MalfunctionFeb 6, 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 DURING REWIND PROCESS. CUSTOMER STATED THAT THE INSULIN PUMP WAS FELL. DRIVE SUPPORT CAP WAS FLUSH. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9675600 ↗
• MalfunctionJan 24, 2020Detachment of Device or Device Component; Power Problem; Patient Device Interaction Problem; Detachment of Device or Device Component; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CAP ON BOTTOMS OF INSULIN PUMP UNDER RESERVOIR POPS OUT WHEN INSULIN PUMP HITS SOMETHING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT INSULIN PUMP HAD SCRATCHED ON THE SCREEN AND REJECT NEW BATTERY ONCE OR TWICE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9626848 ↗

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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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