Paradigm® REAL-Time Revel™ MMT-723LNAS (UDI 00763000161132)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,909 adverse event reports that list this exact device (DI 00763000161132), received between Oct 19, 2018 and Jul 25, 2022 — classified as 18 deaths, 1,152 injuries, 1,739 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (628 reports).

1 FDA recall record name this device's identifier, 1 still open.

13 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.

Recalls naming this device

1. Feb 13, 2026Class IIOpen, Classified

   All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

   Z-1750-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,909 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2022Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD REWIND ANOMALY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15091939 ↗
• MalfunctionMay 17, 2021Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND INSULIN PUMP. CUSTOMER STATED THAT THEY PERFORMED DISPLACEMENT TEST AND INSULIN PUMP DID PASS IT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11830535 ↗
• MalfunctionApr 18, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BACK LIGHT INSTANT WORKING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 11683597 ↗
• MalfunctionNov 3, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER REPORTS THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND AND DISPLACEMENT TEST ALSO PASSED. 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 10782757 ↗
• MalfunctionOct 28, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEIR INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID NOT RECEIVE MOTOR POSITION ENCODER ALARM. CUSTOMER STATED THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10745340 ↗
• InjurySep 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS ALMOST 600 MG/DL AND TREATED IT WITH INSULIN PUMP. IT WAS REPORTED THAT RESERVOIR COMPARTMENT WAS CRACKED ALL THE WAY AROUND AND BLACK PLASTIC RING WAS CRACKED. CUSTOMER STATED THERE WAS PHYSICAL DAMAGE TO RESERVOIR RING AND RESERVOIR WAS ABLE TO LOCK IN PLACE. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10600625 ↗
• MalfunctionSep 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BROKE WHEN THE CUSTOMER FELL OFF WHILE RIDING THE BIKE. 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 10598499 ↗
• MalfunctionSep 29, 2020Obstruction of Flow; Battery Problem; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED RANDOM NO DELIVERY ALARM AND HAS TO REPLACED THE BATTERY MORE THAN ONCE IN WEEK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10597996 ↗
• MalfunctionSep 18, 2020Communication or Transmission Problem; Communication or Transmission Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT DELIVERING PROPER AMOUNT OF INSULIN. 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 10552345 ↗
• MalfunctionAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD DIFFICULTY TO PROGRAM. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 236 MG/DL BUT THEY HAD ALREADY TREATED IT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10441779 ↗
• MalfunctionAug 18, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND THE PISTON ON THE INSULIN PUMP WAS NOT MOVING LIKE IT NORMALLY. 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 10419946 ↗
• MalfunctionAug 13, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD KEYPAD ANOMALY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER HAD TO PRESS THE ACT AND ESCAPE BUTTON A FEW TIME AND RESPONDING REALLY SLOW. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10400887 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER HAD HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS MORE THAN 500 MG/DL. THE CUSTOMER STATED THAT, THIS MORNING THE BLOOD GLUCOSE WENT HIGH TO MORE THAN 600 MG/DL. THE SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE WERE THIRSTY AND METALLIC TASTE IN MOUTH. THE HIGH BLOOD GLUCOSE WAS TREATED WITH BOLUS. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10400852 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Power Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; Power Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 524 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED POWER LOSS ALARM AND WAS ABLE TO CLEAR THE ALARM AND WAS ABLE TO REWIND THE INSULIN PUMP. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10400697 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS NOT USING THE 670G INSULIN PUMP SO, THE AUTO MODE WAS NOT ACTIVE. CUSTOMER SAID THEY GAVE THEMSELVES TOO MUCH INSULIN THROUGH MANUAL BOLUS.

  Patient problems: Hypoglycemia

  MAUDE report 10400600 ↗
• InjuryAug 13, 2020Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUES WERE 473, 454 AND 416 MG/DL AT THE TIME OF THE INCIDENT. INSULIN PUMP HAD NO DELIVERY ALERTS. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. FRN-MMT-326-RSVR, UNOMED INF SET.

  Patient problems: Hyperglycemia

  MAUDE report 10400294 ↗
• InjuryAug 12, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS BETWEEN 250 MG/DL TO 300 MG/DL AND 40 MG/DL TO 50 MG/DL. THE CUSTOMER ALSO STATED THAT THEY DID ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM NOR ADMITTED INTO HOSPITAL. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10396202 ↗
• InjuryAug 12, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA CALL THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL OF 40 TO 50 MG/DL. CUSTOMER HAD BLOOD GLUCOSE LEVEL OF 250 TO 300 MG/DL. CUSTOMER WAS ALLEGING INSULIN PUMP FOR UNDER DELIVERING BECAUSE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT GOING DOWN. CUSTOMER STATED THAT THERE WAS NO AIR BUBBLES AND LEAK. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10396108 ↗
• MalfunctionAug 12, 2020Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE NOT RESPONDING. CUSTOMER STATED THEY PRESS ACT BUTTON AND UNABLE TO UNLOCK THE INSULIN PUMP. CUSTOMER STATED BATTERY POWER NOT RESPONDING AT ALL. 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 10396059 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10394984 ↗
• MalfunctionAug 12, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE DRIVE SUPPORT CAP WAS NORMAL-SLIGHTLY INDENTED. THE INSULIN PUMP HAD MOTOR ERROR AGAIN. 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 10394698 ↗
• InjuryAug 12, 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, TREATED WITH INSULIN PUMP. THE CUSTOMER STATED THAT CURRENT BLOOD GLUCOSE VALUE WAS 110 MG/DL, AND SHE USES DEXCOM FOR SUGARS TAKES FINGER STICK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10394618 ↗
• MalfunctionAug 11, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER WAS NOT ABLE TO CLEAR ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. INSULIN PUMP RECEIVED MECHANICAL ERROR WHICH CUSTOMER WAS ABLE TO CLEAR BUT NOT ABLE 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 10391569 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCE HIGH BLOOD GLUCOSE AND LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL, 508 MG/DL AND 163 MG/DL. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION SYRINGE. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL. DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10390096 ↗
• InjuryAug 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

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 400 MG/DL, WHICH WAS TREATED WITH INSULIN PUMP. THE CUSTOMER STATED THAT CURRENT BLOOD GLUCOSE VALUE WAS 110 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10390087 ↗

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-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-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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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