PARADIGM® REAL-time MMT-722NAS (UDI 00613994271402)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00613994271402), received between Aug 21, 2017 and Dec 8, 2025 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER REPORTED DAMAGE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-722NAS. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-722NAS WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741589 ↗
• MalfunctionOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER'S WIFE WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN AN UNKNOWN LOCATION. THE CAUSE OF DEATH WAS SEVERE CARDIAC ARREST. THE CALLER DID NOT STATE WHETHER THE CUSTOMER HAD ANY OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP HAD BEEN DISCONNECTED MORE THAN 48 HOURS PRIOR TO PASSING. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. PUMP HAD UNEXPECTED VIBRATOR NOISE DURING VIBRATE CHECK DUE TO ADHESIVE NOT ADHERING THE VIBRATOR MOTOR TO THE CASE. THIS REPORT WAS CREATED FOR THE FAILURE ANALYSIS RESULTS.

  Patient problems: Death

  MAUDE report 10689332 ↗
• MalfunctionMar 31, 2020Premature Discharge of Battery; Battery Problem; Power Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD SCRATCHED ON THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT INSULIN PUMP WAS REJECTED NEW BATTERY AND CHANGED EVERY THREE DAYS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908865 ↗
• MalfunctionOct 31, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER ALSO STATED THAT BELT CLIP WAS BROKEN. 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261184 ↗
• MalfunctionAug 5, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COUPLE MOTOR ERRORS IN THE PAST. BUTTONS WERE MORE DIFFICULT TO PRESS AND SOMETIMES STICK WHEN PRESSED. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THERE WERE A FEW CRACKS ON THE OUTER CASING PUMP AROUND THE RESERVOIR COMPARTMENT. THERE WAS A FAINT RAINBOW AFFECT ON DISPLAY SCREEN SOMETIMES MAKING IT DIFFICULT TO READ. DURING THE REWIND PROCESS, INSULIN PUMP WAS LOUDER AND MAKING A GRINDING SOUND ON OCCASION AND SOMETIMES SQUIRT INSULIN WHEN PRIMING INSTEAD OF DRIPPING OUT FROM THE END. CUSTOMER WILL NOT RETURN DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858905 ↗
• MalfunctionJul 12, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. THE CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. THE CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT THEY RECEIVED ALARM AFTER EVERY BATTERY CHANGE. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP AND THAT PATIENT MAY CONTINUE TO WEAR THE PUMP UNTIL REPLACEMENT ARRIVES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8784115 ↗
• MalfunctionJul 12, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 205 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ASSISTED WITH TROUBLESHOOT AND INSULIN PUMP HAD UNEXPECTED RESTART ALARM AGAIN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783655 ↗
• MalfunctionJun 19, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA THAT THE INSULIN PUMP ALARMED FOR COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 351 MG/DL. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS PROTRUDE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEED 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 8710759 ↗
• MalfunctionJun 4, 2019Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN SQUIRTS FROM CANNULA WHEN PRIMING IT HAD HAPPENED ONCE OR TWICE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE CRACK IN RESERVOIR AREA TOP OUT OF THE O RING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8665818 ↗
• MalfunctionApr 22, 2019Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT SCRATCHES WAS OCCURRED IN DISPLAY AND UNABLE TO READ THE DISPLAY. BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT WHEN CHANGING RESERVOIR PIECE OF PLASTIC WAS CHIPPING OFF. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8534945 ↗
• MalfunctionMar 26, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED AND BUTTONS WAS NOT WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT BATTERY COMPARTMENT WAS CRACKED AND BUTTONS WERE STICKING. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN 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 8451589 ↗
• InjuryNov 19, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 450 MG/DL AT TIME OF INCIDENT AND INSULIN PUMP HAD KEYPAD UNRESPONSIVE. CUSTOMER TREATED WITH MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE LEVEL. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8083477 ↗
• MalfunctionSep 6, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND MOTOR POSITION ENCODER ERROR . CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 131 MG/DL. THE CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP DUE TO ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7851748 ↗
• MalfunctionAug 7, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN IS SQUIRTING OUT DURING MANUAL PRIME PROCESS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. DURING TROUBLESHOOTING, THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER WAS INSTRUCTED TO CHANGE THE INFUSION SET AND RESERVOIR TO RE- START THE PRIMING PROCESS BUT RECEIVED THE FAILURE TO CYCLE ALARM, THUS DID THE TROUBLESHOOTING BUT WAS UNABLE TO RESOLVE. 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 EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7760004 ↗
• MalfunctionJul 9, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 111MG/DL 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 AND WAS ABLE TO COMPLETE THE REWIND PROCESS BUT THEN ALARMED MOTOR ERROR. 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 7670291 ↗
• MalfunctionJun 14, 2018Device Displays Incorrect Message

  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 INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7599966 ↗
• MalfunctionMar 27, 2018Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THE REWIND MESSAGE OCCURRED AFTER THE ALARM. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL AFTER THE CUSTOMER PUSHED IT BACK IN AFTER IT SEEMED TO BE STICKING OUT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROFESSIONAL¿S INSTRUCTION. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372520 ↗
• MalfunctionNov 14, 2017Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND A MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM DURING PRIMING PROCESS AND A MOTOR ERROR ALARM DURING REWIND. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 7031585 ↗
• MalfunctionAug 30, 2017Device Displays Incorrect Message; Material Protrusion/Extrusion

  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 THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 6832089 ↗
• MalfunctionAug 21, 2017Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED OR BUMPED PRIOR TO THE COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. THE 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 BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6807578 ↗

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-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-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-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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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