Paradigm® REAL-Time Revel™ MMT-723NAP (UDI 00613994743923)Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00613994743923), received between Jun 8, 2017 and Feb 4, 2021 — classified as 11 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (12 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2021Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279237 ↗
• MalfunctionAug 7, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED KEYPAD ANOMALY. 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 10377965 ↗
• MalfunctionFeb 24, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR. CUSTOMER WAS ABLE TO CLEAR THE ALARM SUCCESSFULLY AND WAS ABLE TO REWOUND THE INSULIN PUMP. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS 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 9748344 ↗
• MalfunctionFeb 5, 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 INSULIN PUMP NOT DROPPED OR BUMPED. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT, THEY WERE ABLE TO PUSH IT BACK IN. 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 9670191 ↗
• MalfunctionJan 17, 2020Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 179 MG/DL. CUSTOMER STATED THAT INSULIN PUMP WAS NOT WORKING. CUSTOMER STATED THAT THE INSULIN PUMP HAD BATTERY OUT LIMIT ALARM. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND IT WAS ADVANCES. 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 9599775 ↗
• MalfunctionNov 6, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARMS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 183MG/DL. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND AND WAS ABLE TO COMPLETE PUMP REWIND. THE CUSTOMER 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 9284176 ↗
• MalfunctionOct 23, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALARMED FOR COMPROMISED FORCE SENSOR SYSTEM AND DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP HAD ALARM DURING SEATING THE FORCE SENSOR DID NOT DETECT THE RESERVOIR AND INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND RECOMMENDED CUSTOMER REFER TO BACK UP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9224151 ↗
• MalfunctionOct 18, 2019Obstruction of Flow; Material Integrity Problem; Insufficient Device Problem Information; Obstruction of Flow; Material Integrity Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED EVERY MORNING AND EVERY EVENING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE UNEXPLAINED NO DELIVERY ALARMS AND BATTERY CAP WAS FALLING APART. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9206166 ↗
• MalfunctionSep 19, 2019Failure to Cycle; Failure to Cycle

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 138 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER 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 9086324 ↗
• MalfunctionAug 27, 2019No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER'S BLOOD GLUCOSE WAS 282 MG/DL. THE INSULIN PUMP GOT SUBMERGED IN WATER AND IT WAS NOT WORKING. THE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, REVERT TO A BACKUP PLAN AND THE INSULIN PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934348 ↗
• MalfunctionAug 26, 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 HAD COMPROMISED FORCE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 184 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATES INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 8929434 ↗
• MalfunctionAug 8, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. THE CUSTOMER 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 8873013 ↗
• MalfunctionJul 16, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE BLOOD GLUCOSE LEVEL WAS 86 MG/DL. BUTTONS SEEM TO BE STUCK WHEN CUSTOMER PRESSES THEM FOR MORE THAN ONCE A TIME. THE CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND FOUND THAT TIME WAS MOVING FORWARD NORMALLY. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED AND DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8792857 ↗
• MalfunctionJun 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER WAS NOT ASSISTED WITH TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8665510 ↗
• MalfunctionMay 21, 2019Mechanical Problem; Material Integrity Problem; Power Problem; Mechanical Problem; Material Integrity Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND REJECTING NEW BATTERIES. 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 8626362 ↗
• MalfunctionApr 27, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD BUTTON ISSUE. CUSTOMER¿S BLOOD GLUCOSE WAS 109 MG/DL AT THE TIME OF INCIDENT. CUSTOMER SAID THAT THERE WAS A BLACK CIRCLE ON THE SCREEN AND THE TIME WAS ADVANCING BUT NONE OF THE BUTTONS WERE WORKING, SO THEY TOOK THE BATTERY OUT AND GOT A BUTTON ERROR. CUSTOMER SAID THAT INSULIN PUMP WAS WORKING FINE WHEN SHE WENT TO SLEEP AND IT WOKE HER UP BEEPING THIS MORNING. THE CUSTOMER 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 8558927 ↗
• MalfunctionApr 2, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. 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 8472831 ↗
• MalfunctionMar 28, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER¿S HUSBAND REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND DISPLAYABLE HISTORY CRC CHECK FAILED ON STARTUP. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATES INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 8459244 ↗
• MalfunctionMar 14, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR AND DRIVE SUPPORT CAP WAS STICKING OUT. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 370 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8420226 ↗
• MalfunctionFeb 22, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR LIP RING PIECE WAS BROKE OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS DECLINED FOR DAMAGE AND NOTICED THE RESERVOIR BARELY LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WILL NEED TO BE REPLACED AND TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8360755 ↗
• MalfunctionFeb 8, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 162 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATES THEY CANNOT REWIND. 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 8319254 ↗
• MalfunctionFeb 1, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS LOCKED UP AND WAS UNRESPONSIVE. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD A CRACK, REWIND WAS SLOWER BUTTONS WERE NOT ALWAYS RESPONSIVE WHEN PRESSED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8296333 ↗
• InjuryJan 2, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. THE CUSTOMER DID NOT PROVIDE THE SYMPTOMS REGARDING HIGH BLOOD GLUCOSE. THE CUSTOMER WAS STATED THAT THE INSULIN PUMP ALARMED WITH MOTOR ERROR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8207732 ↗
• MalfunctionJan 2, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR ERROR ENCODED POSITION ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE PRODUCT WILL RETURN FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207692 ↗
• MalfunctionDec 17, 2018Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Insufficient Flow or Under Infusion; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THEIR INSULIN PUMP HAD A POSSIBLE UNDER-DELIVERY; THEIR BOLUSES WILL NOT LOWER THEIR BLOOD GLUCOSE AS EXPECTED. THERE WERE ALSO CRACKS NEAR THE DISPLAY SCREEN. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF INCIDENT IS UNKNOWN. TROUBLESHOOTING DID NOT OCCUR. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8168304 ↗

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