PARADIGM® REAL-time MMT-722NAP (UDI 00613994622563)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00613994622563), received between May 11, 2017 and Jul 21, 2020 — classified as 1 death, 6 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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 21, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER WAS NOT ABLE TO COMPLETE THE PRIME PROCESS. CUSTOMER DECLINED TROUBLESHOOTING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301151 ↗
• MalfunctionJun 26, 2020Computer Software Problem; Use of Device Problem; Patient Device Interaction Problem; Computer Software Problem; Use of Device Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD FATAL ERROR. CUSTOMER STATED INSULIN PUMP HAD LOST SETTING DURING BATTERY CHANGE, SMALL CRACK BY FRONT SCREEN. TROUBLESHOOTING WAS PERFORMED. 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 10199116 ↗
• MalfunctionJun 26, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD HARD TO PRESS BUTTONS. THE CUSTOMER STATED INSULIN PUMP HAD SLOW REWINDS WITH UNEXPLAINED NO DELIVERY ALARMS. 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 10199027 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED SEIZURES. CUSTOMER DID NOT TROUBLESHOOT THEIR LOW BLOOD GLUCOSE READING. CUSTOMER STATED THE INSULIN PUMP STOPPED WORKING. INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

  Patient problems: Seizures

  MAUDE report 10039380 ↗
• MalfunctionApr 17, 2020Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. IT WAS ALSO MENTIONED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. NO FURTHER DETAILS WERE PROVIDED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTION. THE CUSTOMER WILL RECEIVE A REPLACEMENT INSULIN PUMP AND WILL RETURN THE ONE THEY CURRENTLY USE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9973710 ↗
• MalfunctionApr 10, 2020Display or Visual Feedback Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL FAILED BATTERY TEST AND NO DELIVERY ALARM ON THE INSULIN PUMP. TROUBLESHOOTING WAS NOT PERFORMED. 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 9949208 ↗
• MalfunctionApr 2, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT FIXED PRIME OR FILL CANNULA OF 5 UNIT WAS PERFORMED AND INSULIN EXITED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9915276 ↗
• MalfunctionMar 27, 2020Premature Discharge of Battery; Mechanical Problem; Power Problem; Premature Discharge of Battery; Mechanical Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889536 ↗
• MalfunctionNov 28, 2019Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTON ERROR AS CUSTOMER WENT ON SWIMMING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT TIME ADVANCES DURING THE ISSUE AND BUTTON WAS NOT RESPONDING. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9389302 ↗
• MalfunctionOct 1, 2019Mechanical Problem; Priming Problem; Mechanical Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PRIME ANOMALY AND MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED ITS SHOOTING OUT THE INSULIN. 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 9138651 ↗
• MalfunctionSep 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND THE BUTTONS DOES NOT WORK. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. NO TROUBLESHOOTING WAS PERFORMED. INSULIN PUMP IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9097023 ↗
• MalfunctionJun 6, 2019Defective Device

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD AN UNRESPONSIVE KEYPAD. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. CUSTOMER WAS ABLE TO VERIFY THAT THE TIME WAS ADVANCING ON THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674106 ↗
• MalfunctionJun 6, 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 ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. 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 8673335 ↗
• InjuryApr 23, 2019Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 397 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP DID NOT ALERT OCCLUSION OR NO DELIVERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8540576 ↗
• InjuryApr 17, 2019Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD A CRACK ON IT AND THE SCREEN GOES CLOUDY BLACK AT TIMES AND WAS DIFFICULT TO READ. 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 8521679 ↗
• MalfunctionApr 10, 2019Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT SQUIRTS INSULIN WHEN PRIMING MORE COMMON THAN DRIPPING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED BATTERY PORT CRACKED AND SLOWER TO REWIND AND DIMINISHED BATTERY. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8498845 ↗
• MalfunctionApr 4, 2019Device Difficult to Program or Calibrate; Detachment of Device or Device Component; Device Difficult to Program or Calibrate; Detachment of Device or Device Component

  IT WAS REPORTED VIA PHONE CALL THAT THE DRIVE SUPPORT CAP OF THE INSULIN PUMP WAS LOOSE. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER ALSO STATED THAT THE KEYPAD WAS UNRESPONSIVE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND 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 8481336 ↗
• MalfunctionMar 29, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CRACKS ON THE SCREEN MAKING IT HARD TO READ. CUSTOMER'S BLOOD GLUCOSE LEVEL 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 8463342 ↗
• MalfunctionJan 25, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD RECEIVED MOTOR ERROR AND MOTOR POSITION ENCODER ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM. THE CUSTOMER DECLINED TROUBLESHOOTING FOR MOTOR POSITION ENCODER ERROR. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACKUP PLAN, PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8277890 ↗
• MalfunctionJan 16, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DAMAGE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN WHICH MAKES IT DIFFICULT TO READ THE SCREEN. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD MOTOR ERRORS RECEIVED AND THE INSULIN PUMP SQUIRTED OUT DURING PRIMING. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP BUTTONS ARE HARDER TO PRESS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8251878 ↗
• MalfunctionDec 27, 2018Computer Software Problem; Application Program Version or Upgrade Problem; Computer Software Problem; Application Program Version or Upgrade Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD NEW SOFTWARE RELEASE DETECTED AS WELL AS FAILURE OF FLASH MEMORY. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER STATED THAT THEY ALSO RECEIVED A LOW BATTERY ALERT. THE CUSTOMER STATED THAT THEY CHANGED BATTERY IN INSULIN PUMP AND GOT A NEW SOFTWARE RELEASE DETECTED ALARM. THE CUSTOMER STATES AFTER CLEARING THE ALERT CUSTOMER GOT FAILURE OF FLASH MEMORY ALARM. THE CUSTOMER STATES AFTER INSULIN PUMP RESTART CUSTOMER GOT A SECOND NEW SOFTWARE RELEASE DETECTED ALARM. 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 8198588 ↗
• MalfunctionOct 9, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT THE INSULIN PUMP HAD FAILED BATTERY TEST ALARM. 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: Hyperglycemia

  MAUDE report 7948712 ↗
• MalfunctionSep 12, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 156 MG/DL. TROUBLESHOOTING WAS PERFORMED FOR PRIME REWIND. THE CUSTOMER INDICATED THAT THE DRIVE SUPPORT CAP WAS FLUSHED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7871757 ↗
• MalfunctionJun 20, 2018Device Displays Incorrect Message; Noise, Audible

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. THE BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS MAKING A NOISE. THE CUSTOMER STATED THAT THE ERROR CAME 2 TIMES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7622379 ↗
• MalfunctionFeb 23, 2018Failure to Power Up; Battery Problem

  IT WAS REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS TURNED OFF AND NOT ABLE TO ON DUE TO BATTERY ISSUE. CUSTOMER PERFORMED TROUBLESHOOT BUT INSULIN PUMP DID NOT TURN ON. INSULIN PUMP WILL BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7293065 ↗

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-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• 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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-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