PARADIGM® REAL-time MMT-722NAL (UDI 00613994622570)Recalls & reported problems

Summary

The FDA's MAUDE database contains 290 adverse event reports that list this exact device (DI 00613994622570), received between Jun 1, 2017 and Jul 30, 2020 — classified as 1 death, 35 injuries, 254 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (65 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 290 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2020Failure to Cycle; Mechanical Problem; Failure to Cycle; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM AND INSULIN PUMP WAS STUCK ON REWIND. CUSTOMER STATED INSULIN WAS NOT SPOUTING AFTER MOTOR STOP DURING FILL MANUAL 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 10342381 ↗
• MalfunctionJul 28, 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. 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 10336511 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WENT UP TO 420 MG/DL. CUSTOMER HAD SYMPTOMS AS HEADACHE AND DRY MOUTH. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Headache; Hyperglycemia; Polydipsia

  MAUDE report 10256285 ↗
• MalfunctionJul 9, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE UP ARROW ON INSULIN PUMP KEYPAD WAS UNRESPONSIVE. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE INSULIN PUMP CLOCK 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 10256066 ↗
• MalfunctionJul 6, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER CHANGED INSULIN PUMP BATTERY AND PUMP DID NOT STARTED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. INSULIN PUMP WAS NOT DROPPED, BUMPED, EXPOSED TO MOISTURE OR PRESENT PHYSICAL DAMAGE. CUSTOMER INSERTED A NEW BATTERY INTO INSULIN PUMP AND PUMP STARTED BUT PRESENTING TIME LIMIT WITHOUT BATTERY ALARM AND BATTERY ICON WAS EMPTY. CUSTOMER AGAIN REMOVE AND INSERTED BATTERY INTO INSULIN PUMP AND PUMP DID NOT TURN ON. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10231680 ↗
• MalfunctionJul 1, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEIR 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 10216697 ↗
• MalfunctionJul 1, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP WAS STOPPED WORKING AND RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER REPORTED DRIVE SUPPORT CAP WAS FLUSH. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10216377 ↗
• InjuryJun 15, 2020No Display/Image; Detachment of Device or Device Component; No Display/Image; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CUSTOMER HAD HYPERGLYCEMIA AND INSULIN PUMP HAD BLANK DISPLAY AS WELL AS DRIVE SUPPORT CAP WAS FLUSH. BLOOD GLUCOSE LEVEL WAS 441 MG/DL AND 500 MG/DL. CUSTOMER REPORTED THAT THEY HAD ABDOMINAL PAIN. CUSTOMER WAS TREATED WITH SYRINGES. CUSTOMER WAS CONTACTED TO THEIR HEALTHCARE PROFESSIONAL REGARDING THEIR HYPERGLYCEMIA. TROUBLESHOOTING WAS PERFORMED FOR BLANK DISPLAY. OTHER TESTS WERE NOT PERFORMED BECAUSE IT WAS NOT POSSIBLE DUE TO BLANK DISPLAY ISSUE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10156183 ↗
• MalfunctionJun 15, 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. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARS LOOSE. 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 10156148 ↗
• MalfunctionJun 1, 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. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARS LOOSE. 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 10104930 ↗
• MalfunctionMay 27, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. 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 10090868 ↗
• InjuryMay 25, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AND 400 MG/DL. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF AND TIME ADVANCES. THE PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10085754 ↗
• MalfunctionApr 23, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. CUSTOMER STATED THAT THE BATTERY AREA WAS CRACKED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9992810 ↗
• MalfunctionApr 15, 2020Device Alarm System; Device Alarm System

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD ABSENCE OF NO DELIVERY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT 4 CATHETERS UNITS WAS OCCLUDED, THEY WERE NOT BENT. TESTS WERE PERFORMED AND THE PUMP WAS OK. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9966114 ↗
• MalfunctionApr 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP FELL OUT AND AFTER THIS THE PISTON WAS NOT WORKING PROPERLY AND INSULIN PUMP WAS CRACKED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953721 ↗
• MalfunctionMar 25, 2020Mechanical Problem; Detachment of Device or Device Component; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Detachment of Device or Device Component; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER REPORTED SEVERAL BATTERY ALERTS. TROUBLESHOOTING WAS PERFORMED. THE ALARM HISTORY WAS REVIEWED AND THERE WERE FAILED BATTERY TEST ALERTS. CUSTOMER SATED THAT DRIVE SUPPORT CAP WAS LOOSE AND STATED THAT INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881079 ↗
• MalfunctionMar 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. CUSTOMER REPORTED THAT DURING INFUSION SET CHANGE THE PISTON DID NOT IDENTIFY THE RESERVOIR AND INSULIN SQUIRTED OUT. THERE WAS NO GAP BETWEEN THE PISTON AND THE RESERVOIR STOPPER AND INSULIN CONTINUE TO DRIP AFTER LETTING GO OF THE ACT BUTTON. THE ISSUE OCCURRED WITH DIFFERENT INFUSION SETS. THE ALARM HISTORY WAS REVIEWED AND THERE WAS NO ISSUE ALERT. 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 9858101 ↗
• MalfunctionMar 14, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS DAMAGED. 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 9833075 ↗
• MalfunctionFeb 28, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER REPORTED THAT THE INSULIN PUMP ERROR ALARM WAS REOCCURRED. 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 9767809 ↗
• MalfunctionFeb 21, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THE UP AND ARROW KEY WAS RESPONDING WITH GREAT DIFFICULTY, AND HAD TO PRESS THE BUTTON HARDLY. 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 9737990 ↗
• MalfunctionFeb 17, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED INSULIN SQUIRTED OUT FROM THE INSULIN PUMP, AFTER ALERT THE INSULIN PUMP LOCKED IN THE REWIND LOOP. 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 9718627 ↗
• MalfunctionFeb 12, 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 THAT THE TROUBLESHOOTING WAS PERFORMED. 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 9697981 ↗
• MalfunctionJan 17, 2020Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 347 MG/DL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THE CHANGING THE SET AND INSULIN SHOOTS OUT WHILE PRIMING. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED, 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 9599765 ↗
• MalfunctionJan 16, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSULIN PUMP HAD COMPROMISED FORCED SENSOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150 MG/DL. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS LOOSENED. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9599437 ↗
• MalfunctionJan 16, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 88 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL AND INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. THE CUSTOMER WAS ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9599405 ↗

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-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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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