Paradigm® REAL-Time Revel™ MMT-723NAL (UDI 00643169507234)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,504 adverse event reports that list this exact device (DI 00643169507234), received between May 15, 2017 and Nov 3, 2023 — classified as 9 deaths, 432 injuries, 1,063 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (269 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 1,504 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2023Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER MENTIONED PUMP HAD INSULIN FLOW BLOCK ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. IT WAS UNKNOWN IF THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS AND IF THE AUTO-MODE/SMARTGUARD FEATURE WAS ACTIVE AT THE TIME OF HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WILL DISCONTINUE USE OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 18065824 ↗
• MalfunctionFeb 19, 2021Obstruction of Flow; Power Problem; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS REJECTING NEW BATTERIES AND HAD UNEXPLAINED RANDOM NO DELIVERY ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 11348276 ↗
• MalfunctionDec 11, 2020Mechanical Problem; Mechanical Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10990531 ↗
• MalfunctionOct 28, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NO DROPPED OR BUMPED. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER 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 10745251 ↗
• MalfunctionOct 13, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THEY WERE ABLE TO SUCCESSFULLY CLEAR THE ALARM AND WAS 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 10668700 ↗
• MalfunctionSep 10, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND NO DELIVERY ALARM. THE CUSTOMER STATED THEY WERE ABLE TO COMPLETE REWIND PROCESS AND DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT INSULIN PUMP WAS EXPOSED TO HIGH MAGNETIC FIELD. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10512584 ↗
• MalfunctionAug 11, 2020Excess Flow or Over-Infusion; Obstruction of Flow; Power Problem; Excess Flow or Over-Infusion; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP OVER DELIVERING THE INSULIN TO CUSTOMER. THE CUSTOMER STATED THAT, THE INSULIN WAS DELIVERED TO HIM WHEN IT SHOULD NOT BE ESPECIALLY AT NIGHT. THE INSULIN PUMP HAD NO DELIVERY ALARM AND REJECTED BRAND 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 10389964 ↗
• MalfunctionAug 11, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE STUCK ON THE INSULIN PUMP. CUSTOMER STATED INSULIN PUMP WAS NOT EXPOSED TO MOISTURE. 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 10389385 ↗
• MalfunctionAug 7, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. THE CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM AND NOT ABLE TO REWIND THE INSULIN PUMP. THE DRIVE SUPPORT CAP APPEARED 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 10379233 ↗
• MalfunctionAug 7, 2020Device Alarm System; Power Problem; Device Alarm System; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BEEP ANOMALY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WAS NOT GETTING LOW BATTERY ALERTS. CUSTOMER PERFORMED SELF TEST AND INSULIN UMP DID NOT BEEP DURING THE TONE TEST. CUSTOMER STATED THEY DID RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. CUSTOMER STATED THE BATTERY WAS NOT PREVIOUSLY USED. CUSTOMER STATED THE BATTERY CAP WAS NOT LOOSE, CRACKED OR DAMAGED. CUSTOMER STATED THIS WAS THE SECOND OCCURRENCE OF OFF NO POWER WITHOUT A LOW BATTERY WARNING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10377627 ↗
• MalfunctionAug 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT ACT BUTTON OF INSULIN PUMP WAS NOT WORKING AND THEY HAD TO PRESS IT SEVERAL TIMES TO GET IT TO WORK. 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 10372227 ↗
• MalfunctionAug 6, 2020Device Alarm System; Premature Discharge of Battery; No Display/Image; Device Alarm System; Premature Discharge of Battery; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY SCREEN. THE CUSTOMER ALSO STATED THAT, THE DISPLAY DID NOT RETURN AFTER PUMP RESTART. THE CUSTOMER ALSO STATWED THAT, THE INSULIN PUMP HAD UNEXPECTED RESTART 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 10371501 ↗
• MalfunctionAug 5, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT BUTTON OF INSULIN PUMP WAS NOT WORKING. THE CUSTOMER STATED THAT THEY HAD TO PRESS IT SEVERAL TIMES TO GET IT TO WORK. 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 10366457 ↗
• MalfunctionAug 4, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT BUTTON WAS UNRESPONSIVE AND MAKING PRESS MULTIPLE TIMES TO GET RESPOND. INSULIN PUMP WAS SLOWER DURING 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 10361289 ↗
• InjuryAug 3, 2020Device Alarm System; Failure to Cycle; Detachment of Device or Device Component; Moisture or Humidity Problem; No Apparent Adverse Event; Device Alarm System; Failure to Cycle; Detachment of Device or Device Component; Moisture or Humidity Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 421 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NOT NORMAL. CUSTOMER STATED THAT INSULIN PUMP WAS VIBRATING WITHOUT AN ALARM OR ALERT. CUSTOMER STATED THAT THERE WAS LEAK FROM RESERVOIR BARREL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10355181 ↗
• MalfunctionJul 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. THE TROUBLESHOOTING WAS PERFORMED AND CUSTOMER ALSO STATED THAT THEY DID NOT RECEIVED ANOTHER UNEXPECTED RESTART ALARM AFTER BATTERY CHANGE. CUSTOMER ALSO STATED THAT ALARM DID NOT OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER STATED THAT UNEXPECTED RESTART ALARM WAS RECURRING DURING NORMAL INSULIN PUMP USE. 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 10343198 ↗
• MalfunctionJul 30, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY ERROR AND MOTOR POSITION ENCODER ERROR. CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM. 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: No Consequences Or Impact To Patient

  MAUDE report 10342645 ↗
• MalfunctionJul 28, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE HARD TO PRESS, STUCK, REJECTED BATTERY AND RECEIVED NO DELIVERY ALARMS. 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 10331047 ↗
• MalfunctionJul 28, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR AND BUTTON ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP RECEIVED UNEXPLAINED NO DELIVERY ALARM AND DIMINISHED BATTERY LIFE FROM DAY 1 USED AS WELL AS REJECT NEW BATTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10330942 ↗
• MalfunctionJul 27, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10325231 ↗
• InjuryJul 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL AND LOW BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT, 227 MG/DL AND 55 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. CUSTOMER WAS NOT USING AUTO MODE OF INSULIN PUMP. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID NOT ALLEGE THAT THE INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10324999 ↗
• MalfunctionJul 24, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. IT WAS STATED THAT THERE WAS UNUSUAL DOSING OF INSULIN, IT MIGHT HAVE NOT BEEN DOSING INSULIN THROUGH INSULIN PUMP, THERE WERE MINOR SCRATCHES ON THE SCREEN, INSULIN PUMP WAS REJECTING BATTERIES. IT WAS STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALERTS, KINK IN THE LINE BUTTONS, UP BUTTON LAGS AND NEED TO PRESS SEVERAL TIMES AND HAD TO PRESS HARD FOR A LONG TIME. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. NOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10318713 ↗
• MalfunctionJul 23, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP TURNED OFF. CUSTOMER INSERTED NEW BATTERY IN IT. 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 10318200 ↗
• MalfunctionJul 21, 2020Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP LOCKED UP AND BECAME UNRESPONSIVE. CUSTOMER STATED INSULIN PUMP HAD REJECT NEW BATTERIES EVEN AFTER GOT NEW BATTERY CAP, REWIND MORE THAN ONCE PER RESERVOIR CHANGE, NO DELIVERY ALARM, BATTERIES LAST LESS THAN SEVEN DAYS. 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 10301721 ↗
• MalfunctionJul 21, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS WORN DOWN AND SCREEN SCRATCHED MAKING IT DIFFICULT TO READ. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND BATTERY LIFE DIMINISHED. 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 10301211 ↗

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-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-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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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