Paradigm® REAL-Time Revel™ MMT-723NAB (UDI 00643169507210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,492 adverse event reports that list this exact device (DI 00643169507210), received between May 22, 2017 and Oct 1, 2020 — classified as 8 deaths, 488 injuries, 996 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (302 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 1,492 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT DRIVE SUPPORT TAB APPEARED NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617359 ↗
• MalfunctionSep 2, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. CUSTOMER DID NOT REPORT AN MOTOR POSITION ENCODER ERROR ALARM. THE CUSTOMER STATED THAT THEY WAS UNSURE IF THE DRIVE SUPPORT CAP WAS PROTRUDED, LOOSE, STICKING OUT OR FLUSH. 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 10481045 ↗
• MalfunctionAug 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PISTON WAS FLUSHING OUT AS WELL AS BUTTONS OF INSULIN PUMP WERE DAMAGED. 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 10390449 ↗
• MalfunctionAug 11, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND WAS ABLE TO REWIND THE INSULIN PUMP. THE 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 10389480 ↗
• MalfunctionAug 10, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR AND UNRESPONSIVE BUTTONS. CUSTOMER STATED THE INSULIN PUMP HAD POOR BATTERY LIFE, SLOWER TO REWIND AND RANDOM NO DELIVERY ALERT. 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 10383775 ↗
• MalfunctionAug 7, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE LESS RESPONSIVE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. 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 10379082 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER WAS EXPERIENCED LOW BLOOD GLUCOSE THAT CAUSE FALL AND SHE BROKE HER FOOT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10377332 ↗
• InjuryAug 6, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 503 MG/DL. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR AND NO DELIVERY ALERT. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10371841 ↗
• MalfunctionAug 5, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM OCCURRED DURING BOLUS. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS CORRECT. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NO DROPPED OR BUMPED. CUSTOMER WAS UNABLE TO REWIND THE INSULIN PUMP. 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 10366615 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Moisture or Humidity Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Moisture or Humidity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM MULTIPLE TIMES DURING A BOLUS. CUSTOMER STATED THAT, THERE WERE CRACKS IN THE PUMP. 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 10366532 ↗
• MalfunctionAug 5, 2020Display or Visual Feedback Problem; Obstruction of Flow; Insufficient Device Problem Information; Display or Visual Feedback Problem; Obstruction of Flow; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED PUMP ERROR ALARM. CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED UNEXPLAINED NO DELIVERY ALARMS AND THERE WAS A RAINBOW EFFECT ON THE SCREEN. CUSTOMER DECLINED TO TROUBLESHOOTING WITH HELPLINE. 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 10366256 ↗
• MalfunctionAug 4, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND EXPERIENCED UNEXPLAINED NO DELIVERY OF INSULIN. NO TROUBLESHOOTING WAS PERFORMED ON THE PUMP DUE TO THE CUSTOMER DECLINED TO REPORT THE EVENT TO THE MEDTRONIC 24 HOUR TECHNICAL SUPPORT DEPARTMENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10361229 ↗
• MalfunctionAug 4, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER STATED THEY INSULIN PUMP ALSO HAD NO DELIVERY 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 10361122 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 400 MG/DL. THE CUSTOMER REPORTED THAT THE CANNULA WAS BENT. THE CUSTOMER DECLINED THE BENT CANNULA AND HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE TAPE WAS NOT STICKING. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10345183 ↗
• MalfunctionJul 29, 2020Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCREEN OF THE INSULIN PUMP WAS SCRATCHED AND WAS NOT ABLE TO SEE IT WHILE OUTSIDE. ALSO THE TOP WHERE THE BATTERY GOES WAS ALL STRIPPED OUT. 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 10337606 ↗
• MalfunctionJul 29, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS ISSUES LESS RESPONSIVE AND STICKING AND HARD TO PRESS. 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 10336741 ↗
• MalfunctionJul 28, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF THE INSULIN PUMP WERE STICKING WHEN PRESSED. ALSO HAD RANDOM NO DELIVERY ALARMS AND THE RESERVOIR NO LONGER GAVE ALERT WHEN EMPTY. 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 10332235 ↗
• MalfunctionJul 28, 2020Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Insufficient Device Problem Information; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PARTIAL DISPLAY. CUSTOMER STATED THAT THERE WAS RANDOM NO DELIVERY ALARM, BACKLIGHT WAS NOT BRIGHT AND SCREEN WAS VERY HARD TO VISUALIZE AS IT WAS DIM. CUSTOMER REPORTED THAT THEY HAD TO REWIND THE INSULIN PUMP MORE THAN ONCE AND IT TOOK LONGER TIME TO REWIND. 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 10331722 ↗
• MalfunctionJul 27, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Priming Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARD TO PUSH. INSULIN PUMP HAD NO DELIVERY ALARM. INSULIN PUMP DID NOT ALARM LOW RESERVOIR. CUSTOMER STATED THAT THE MOTOR SOUNDS LIKE IT WAS WORKING HARD TO REWIND. 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 10325041 ↗
• MalfunctionJul 24, 2020Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP GOT WET AND NOW IT IS NOT WORKING. CUSTOMER JUMPED IN THE WATER AND FORGOT TO TAKE IT OFF AND IT GAVE A STUCK BUTTON ERROR. THE CUSTOMER STATED WAS UNABLE TO CLEAR THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319754 ↗
• MalfunctionJul 24, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE HARDER TO PRESS AND MORE THAN OFTEN. CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALARMS AND BATTERY LIFE WAS OF SIX DAYS OR LESS. CUSTOMER DECLINED TO TROUBLESHOOTING WITH 24 HOURS HELPLINE. 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 10318466 ↗
• MalfunctionJul 22, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THAT INSULIN PUMP STOPPED WORKING, IT WAS JUST A BLANK SCREEN AND THE TOP OF HER RESERVOIR COMPARTMENT WAS CRACKED WITH PLASTIC MISSING. 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 10308228 ↗
• MalfunctionJul 21, 2020Excess Flow or Over-Infusion; Device Difficult to Program or Calibrate; Battery Problem; Excess Flow or Over-Infusion; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM OVER DELIVERING INSULIN AND BUTTON WAS SLUGGISH. CUSTOMER REPORTED THAT BATTERY LASTING LESS. 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 10305994 ↗
• MalfunctionJul 21, 2020Device Alarm System; Mechanical Problem; Obstruction of Flow; Device Alarm System; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SHOWED NO DELIVERY AND DID NOT GIVE NOTICE. THE INSULIN PUMP WAS TAKING A LONG TIME TO REWIND. 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 10300754 ↗
• MalfunctionJul 17, 2020Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Battery Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM, BUTTONS WERE STICKING. CUSTOMER STATED INSULIN PUMP HAD DIMINISHED BACK LIGHT, INSULIN PUMP RANDOMLY RESETS, BATTERY LIFE LAST LESS THEN SEVEN DAYS, REJECTS NEW BATTERIES. 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 10288048 ↗

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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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