PARADIGM® REAL-time MMT-722RNAB (UDI 00613994409188)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994409188), received between Apr 13, 2018 and Feb 20, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2023Break; Power Problem; Break; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATES THAT THE CUSTOMER HAD A SCRATCH ON THE SCREEN AND ALSO PUMP REJECTED NEW BATTERIES. THE CUSTOMER ALSO FOUND THAT BATTERY CAP AREA WAS LITTLE TIGHTER TO SCREW ON. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16402045 ↗
• MalfunctionJun 20, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  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 STICKING OUT. 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 8715423 ↗
• MalfunctionApr 11, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 389 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8502440 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 494 MG/DL AT THE TIME OF INCIDENT. CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING TO HIGH BLOOD GLUCOSE EPISODE. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8330280 ↗
• MalfunctionDec 5, 2018Mechanical Problem; Obstruction of Flow; Power Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Obstruction of Flow; Power Problem; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DIED BEFORE ALERTING TO LOW BATTERY LIFE AND ON REWIND AND PRIME THE INSULIN PUMP WAS LOUDER AS WELL AS UNEXPLAINED NON-DELIVERY ALARMS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE DIMINISHED BATTERY LIFE AS WELL AS REJECTS NEW BATTERIES AND FAILED BATTERY TEST ALARM. CUSTOMER TROUBLESHOOT WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8132124 ↗
• MalfunctionNov 19, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR LIP RING WAS DAMAGED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE RESERVOIR WAS BARELY LOCKING IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8083370 ↗
• MalfunctionJul 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. CUSTOMER ADVISED DURING SEATING THE FORCE SENSOR DID NOT DETECT THE RESERVOIR. CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME PROCESS. CUSTOMER ADVISED THE DRIVE SUPPORT CAP WAS FLUSH. 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 7696981 ↗
• MalfunctionJun 15, 2018Device Displays Incorrect Message; Device Operates Differently Than Expected; Inappropriate or Unexpected Reset

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SEVERAL ISSUES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A FAILED BATTERY TEST, MOTOR ERROR, NO DELIVERY ALARM, UNEXPECTED RESTART, AND POSSIBLE REWIND ANOMALY. NO TROUBLESHOOTING WAS PERFORMED. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604757 ↗
• MalfunctionApr 25, 2018Computer Software Problem; No Display/Image; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND ALSO HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 156 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT DEVICE SOFTWARE ERROR DURING REWIND AND ALSO GOT ALARM COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER WAS ADVISED TO INSERT A NEW BATTERY AS SOON AS POSSIBLE, IF DISPLAY DOES NOT RETURN REVERT TO A BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS UNTIL THE REPLACEMENT BATTERY CAP ARRIVES. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS UNTIL THE REPLACEMENT BATTERY CAP ARRIVES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457471 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND KETOACIDOSIS WITH BLOOD GLUCOSE OF 1000 MG/DL, THE CUSTOMER CURRENT BLOOD GLUCOSE WAS 106 MG/DL. THE CUSTOMER WAS HOSPITALIZED ON 3/24 DAY TIME. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 7428077 ↗

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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-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