Paradigm® REAL-Time Revel™ MMT-523RNAL (UDI 00643169513075)Recalls & reported problems

Summary

The FDA's MAUDE database contains 438 adverse event reports that list this exact device (DI 00643169513075), received between May 16, 2017 and Jul 20, 2021 — classified as 229 injuries, 209 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (55 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 438 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN SHOWS SIGNS OF PHYSICAL DAMAGE ON TOP OF THE RESERVOIR COMPARTMENT. CUSTOMER STATES THE PLASTIC THAT HOLDS THE RESERVOIR INTO THE PUMP HAS BROKEN OFF. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194709 ↗
• MalfunctionSep 11, 2020Mechanical Problem; Obstruction of Flow; Power Problem; Mechanical Problem; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND NO DELIVERY ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARS 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 10520067 ↗
• MalfunctionAug 19, 2020Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S TOP OF THE RESERVOIR COMPARTMENT WAS BROKEN HOWEVER RESERVOIR WAS ABLE TO LOCK IN PLACE. THE CUSTOMER REPORTED THAT THE RESERVOIR FALLS OUT AND LOOSE. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10424518 ↗
• InjuryAug 7, 2020Premature Discharge of Battery; Battery Problem; Loss of Data; Power Problem; Premature Discharge of Battery; Battery Problem; Loss of Data; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA WITH BLOOD GLUCOSE VALUE 45 MG/DL. THE CUSTOMER BLOOD GLUCOSE VALUES RANGING LOW 45MG/DL TO HIGH 381 MG/DL. CUSTOMER ALSO STATED INSULIN PUMP RECEIVED MULTIPLE PUMP ERROR ALARMS. CUSTOMER STATED THEY DID RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. CUSTOMER STATES IT WAS LESS THAN 24 HOURS FROM THE LOW BATTERY ALERT TO THE OFF NO POWER ALERT. CUSTOMER STATED THE BATTERY CAP WAS NOT LOOSE, CRACKED OR DAMAGED. THE INSULIN PUMP WILL NOT RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10377378 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Battery Problem; Power Problem; Premature Discharge of Battery; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED ERROR. CUSTOMER ALSO REPORTED THAT ALARMED RECURRED AFTER INSERTING A NEW BATTERY. TROUBLESHOOTING WAS PERFORMED. THIS WAS THE SECOND OCCURRENCE OF OFF NO POWER WITHOUT A LOW BATTERY WARNING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10366329 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Battery Problem; Power Problem; Premature Discharge of Battery; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED ERROR. CUSTOMER ALSO REPORTED THAT ALARMED RECURRED AFTER INSERTING A NEW BATTERY. TROUBLESHOOTING WAS PERFORMED. THIS WAS THE SECOND OCCURRENCE OF OFF NO POWER WITHOUT A LOW BATTERY WARNING. 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 10366316 ↗
• MalfunctionAug 5, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTONS ARE HARDER TO PRESSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT INSULIN PUMP HAD SCRATCHES ON SCREEN AND MAKES IT HARD TO CONDUCT THERAPY AND NO DELIVERY ALARM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10366281 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366226 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366217 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366191 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366188 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366187 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366175 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366171 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366089 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366087 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366081 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. 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 10366069 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE ABLE TO REWIND INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. 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 10366066 ↗
• MalfunctionAug 5, 2020Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem; Premature Discharge of Battery; Obstruction of Flow; Battery Problem; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM. CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. CUSTOMER STATED THIS WAS SECOND OCCURRENCE OF OFF NO POWER WITHOUT LOW BATTERY WARNING. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE ABLE TO REWIND INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. 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 10366048 ↗
• MalfunctionJul 28, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT DELIVERING EXACT AMOUNT OF INSULIN. 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 10331621 ↗
• MalfunctionJul 20, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MISSING PIECE OF CASING ON THE RESERVOIR LIP RING AREA. 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 10294795 ↗
• MalfunctionJul 13, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARMS. UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED ERROR RECURRED AFTER BATTERY CHANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10262762 ↗
• MalfunctionJul 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS CHIPPED WHERE RESERVOIR WAS AND HALF WAS BROKEN OFF. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE. 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 10262533 ↗
• MalfunctionJul 10, 2020Premature Discharge of Battery; No Display/Image; Device Difficult to Program or Calibrate; Obstruction of Flow; Premature Discharge of Battery; No Display/Image; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS DIED WITHOUT ALERTING LOW BATTERY LIFE. THE CUSTOMER STATED THAT THEY HAD TO RESET THE SETTINGS. THE BUTTONS OF THE INSULIN PUMP WERE HARDER TO PRESS. THE INSULIN PUMP HAD AN UNEXPLAINED NO DELIVERY ALARM AND ANOTHER PUMP ERROR 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 10257320 ↗

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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-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