Paradigm® REAL-Time Revel™ MMT-723LNAS (UDI 00613994748898)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994748898), received between Oct 24, 2017 and Jan 31, 2020 — classified as 1 death, 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE NOT RESPONDING. THE CUSTOMER STATED THAT THEY WERE REWIND AND PRIME THE INSULIN PUMP BUT THEY COULD NOT GET PAST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9651775 ↗
• MalfunctionDec 3, 2019Mechanical Problem; Battery Problem; Material Integrity Problem; Mechanical Problem; Battery Problem; Material Integrity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED CODE ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD CHANGE OUT BATTERIES MORE THAN ONCE A WEEK A FEW TIMES, BATTERY CAP WAS STARTING TO CRACK AND INSULIN PUMP REWINDS SLOWER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9399793 ↗
• MalfunctionNov 12, 2019Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER INSULIN PUMP HAD A BUTTON ERROR ALARM AND MOISTURE EXPOSURE. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. NO TROUBLESHOOTING WAS PERFORMED. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9308080 ↗
• MalfunctionJul 8, 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 AND THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 146 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT . 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 8766690 ↗
• MalfunctionDec 6, 2018No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS 151 MG/DL AT THE TIME OF THE INCIDENT. ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING. CUSTOMER STATED THE DISPLAY DID NOT RETURN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8136598 ↗
• MalfunctionNov 7, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 240 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM AND ABLE TO REWIND. 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 8049310 ↗
• MalfunctionAug 31, 2018Device 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 131 MG/DL 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 DOES NOT DISPLAY ON THE BUTTON ERROR ALARM. 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 7836458 ↗
• MalfunctionMay 15, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 130 MG/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 FIELD AND WAS ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER REPORTED A MOTOR POSITION ENCODER 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 7513512 ↗
• DeathMay 7, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN AN UNKNOWN LOCATION. THE CAUSE OF DEATH WAS UNKNOWN. THE CALLER STATED THAT THE CUSTOMER HAD NO ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CALLER WAS UNSURE IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death

  MAUDE report 7493037 ↗
• InjuryMay 4, 2018Device Inoperable; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 400MG/DL AT THE TIME OF INCIDENT, TREATED WITH MANUAL INJECTION AND DECLINED TO TROUBLE SHOOT FOR HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND PUMP KEYPAD WAS NOT RESPONDING. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7486253 ↗
• InjuryJan 4, 2018Insufficient Flow or Under Infusion

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 487 MG/DL AT THE TIME OF THE INCIDENT, CURRENT BLOOD GLUCOSE WAS 147 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER WAS ALLEGED INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7166324 ↗
• MalfunctionOct 27, 2017Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD EXTERNAL RAM CRC ERROR. ALARM OCCURRED DURING THE REWIND SEQUENCE. CUSTOMER DECLINED TO TROUBLESHOOT FOR UNEXPECTED RESTART. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER WAS ADVISED 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 6984991 ↗
• InjuryOct 24, 2017Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 380 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE BELT CLIP HINGE CATCHED ON TO HIS TUBING AND CAUSED BLOOD GLUCOSE VALUE TO GO TO 500 MG/DL. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVELS. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6971625 ↗
• MalfunctionOct 24, 2017Break; Material Separation; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED DAMAGE ON THE BOTTOM OF THE PUMP AND COME APART AND 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 INSULIN PUMP IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6971345 ↗

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-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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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