Paradigm® REAL-Time Revel™ MMT-723RNAS (UDI 00643169221505)Recalls & reported problems

Summary

The FDA's MAUDE database contains 672 adverse event reports that list this exact device (DI 00643169221505), received between May 26, 2016 and Sep 10, 2024 — classified as 19 deaths, 268 injuries, 385 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (100 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 672 reports, in the reporter's own words as published by the FDA.

• DeathSep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2019. CAUSE OF DEATH WAS CANCER AND ORGAN FAILURE. TROUBLESHOOTING WAS PERFORMED AND THE PUMP WAS NOT WORN AT THE TIME OF PASSING. THE LAST KNOWN PRODUCT(S) FOR THIS CUSTOMER ARE MMT-723RNAS. MMT-723RNAS WAS REQUESTED AND CUSTOMER HAS RETURNED THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 20181278 ↗
• MalfunctionAug 17, 2020Mechanical Problem; Mechanical Problem

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

  Patient problems: Hyperglycemia

  MAUDE report 10412152 ↗
• MalfunctionAug 4, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PARTIAL DISPLAY. CUSTOMER STATED THAT WHEN HE PRESSES THE ACT BUTTON THE SCREEN TURNS TWO DIFFERENT COLORS. CUSTOMER STATED INSULIN PUMP WAS NOT BUMPED OR DROPPED. 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 10361505 ↗
• MalfunctionAug 3, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. 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 10354698 ↗
• MalfunctionJul 28, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS HARD TO PRESS MORE THAN ONCE. CUSTOMER ALSO STATED CRACK ON INSULIN PUMP. 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 10330988 ↗
• MalfunctionJul 22, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER STATED THAT THE TIME CLOCK WAS ADVANCED. 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 10307896 ↗
• MalfunctionJul 16, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP MOTOR ERROR AND BUTTONS WERE NON RESPONSIVE. CUSTOMER STATED ACT BUTTON WAS NOT WORKING. 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 10281961 ↗
• MalfunctionJul 15, 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. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10275672 ↗
• MalfunctionJul 14, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS ISSUES. THE REWIND OF THE INSULIN PUMP WAS SLOWER AND LOUDER. 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 10270480 ↗
• MalfunctionJun 19, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED A MOTOR ERROR AND NO DELIVERY ALARM. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM AND WAS ABLE TO COMPLETE PUMP 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 10172561 ↗
• MalfunctionJun 18, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BUTTON ERROR 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 10166312 ↗
• MalfunctionJun 8, 2020Device Alarm System; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Device Alarm System; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT WORKING AND HAD A BUTTON ERROR ALARM. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND LOW RESERVOIR 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 10127674 ↗
• MalfunctionMay 27, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM BUT NOT ABLE TO COMPLETE 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 10091149 ↗
• MalfunctionMay 27, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTON ERROR ALARM AND INSULIN PUMP WAS NOT WORKING. CUSTOMER REPORTED THAT IT HAD NOT BEEN WORKING FOR OVER 1 WEEK. 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 10090547 ↗
• MalfunctionMay 19, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT BUTTONS OF THE INSULIN PUMP WERE NOT RESPONDING. IT WOULD NOT WORK WITH ANY BUTTONS AND SHE PRESSED ON TRIED DOWN ARROW BUTTON AND IT WAS NOTHING WORKED. CUSTOMER ALSO RECEIVED FAILED BATTERY ALARM. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10068505 ↗
• InjuryMay 12, 2020Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Power Problem; Patient Device Interaction Problem; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 499 MG/DL OR 400 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND CONTINUE FOR LOW BLOOD GLUCOSE. CUSTOMER STOPPED USING INSULIN PUMP AND HAD REVERTED TO SYRINGES. THE CUSTOMER WAS TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THEY DID ALLEGING INSULIN PUMP FOR UNDER DELIVERY DUE TO BOLUSES AND BLOOD GLUCOSE REMAIN HIGH AS WELL AS OVER DELIVERY. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REPORTS THEY DID NOT CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER DID SELF-TEST AND DISPLACEMENT TEST AND BOTH ARE PASSED. THE CUSTOMER STATED THAT THE INSULIN PUMP WORKING BUT IT WAS NOT WORKING NOW AND BROKEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10047662 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA AND HYPOGLYCEMIA WITH BLOOD GLUCOSE LEVEL OF OVER 500 MG/DL AND 47 MG/DL. CUSTOMER PRESSED THE ACT BUTTON BUT NOTHING HAPPENED. CUSTOMER STATED THAT SHE HAD AN EXCESSIVE AMOUNT FOR BREAKFAST. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10041918 ↗
• MalfunctionMar 19, 2020Battery Problem; Power Problem; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SHUT OFF AND NOT WORKING. CUSTOMER STATED THAT THEY DID NOT GOT ANY ALARMS OTHER THAN LOW BATTERY 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 9852009 ↗
• MalfunctionMar 17, 2020Display or Visual Feedback Problem; Obstruction of Flow; Priming Problem; Display or Visual Feedback Problem; Obstruction of Flow; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED REPORTED THAT THE INSULIN PUMP HAD RAINBOW EFFECT ON SCREEN, WHEN PRIMING INSULIN PUMP PISTONS WERE LOUDER AND 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 9841087 ↗
• MalfunctionMar 3, 2020Premature Discharge of Battery; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem; Power Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM MULTIPLE TIMES. CUSTOMER STATED THAT THE INSULIN PUMP DIED WITHOUT GIVING LOW BATTERY WARNING AND IT LOST SETTINGS THRICE IN THE LAST YEAR. CUSTOMER STATED THAT THE BATTERY CAP WAS WORN COULD NOT TIGHTEN UP AS IT SHOULD AND THEY HAD TO PRESS ACT AND DOWN ARROW MORE THAN ONCE. CUSTOMER STATED THAT THE INSULIN PUMP HAD SCRATCHES ON SCREEN AND SCREEN HAD RAINBOW EFFECT AND IT WAS MAKING GRINDING SOUND WHILE PRIMING AND REWINDING. CUSTOMER ALSO STATED THAT THEY WERE CHANGING OUT BATTERIES EVERY WEEK, BATTERY LIFE WAS DIMINISHED, INSULIN PUMP RECEIVED FAILED BATTERIES AND INSULIN PUMP 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 9779079 ↗
• MalfunctionFeb 25, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Premature Discharge of Battery; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER REPORTED THEY WERE UNABLE TO CLEAR THE 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 9748869 ↗
• MalfunctionFeb 17, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RING ON THE RESERVOIR AREA WAS BROKEN AND THE SCREEN WAS ALSO DAMAGED ON INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT RESERVOIR ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9718625 ↗
• MalfunctionJan 28, 2020Mechanical Problem; Environmental Compatibility Problem; Mechanical Problem; Environmental Compatibility Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR POSITION ENCODER ERROR ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO HIGH MAGNETIC FIELDS POSSIBLY MEDICAL RESONANCE INDEX. 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 9640315 ↗
• MalfunctionJan 26, 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 ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER STATED THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THE REWIND MESSAGE OCCURRED AFTER AN ALARM. CUSTOMER STATED DRIVE SUPPORT CAP WAS LOOSE. 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 9630598 ↗
• MalfunctionJan 24, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER WAS NOT ABLE TO REWIND THE INSULIN PUMP. 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 9625365 ↗

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-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-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-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-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