MiniMed® 530G MMT-751LNAS (UDI 00643169507784)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,923 adverse event reports that list this exact device (DI 00643169507784), received between May 10, 2017 and Jul 20, 2021 — classified as 5 deaths, 608 injuries, 1,310 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (367 reports).

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

1 other recall cover devices cleared under the same FDA submission (P120010); 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-1751-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,923 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Break; Battery Problem; Moisture or Humidity Problem; Patient Device Interaction Problem; Break; Battery Problem; Moisture or Humidity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD CONDENSATION INSIDE THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUP HAD BAD READINGS AT TIMES AND FREQUENCY OF THE BATTERY WAS CHANGED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12194668 ↗
• MalfunctionAug 12, 2020Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM, SCRATCHES ON SCREEN AND HAD UNEXPLAINED NO DELIVERY ALARMS. 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 10395201 ↗
• MalfunctionAug 10, 2020Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem; Power Problem; Device Difficult to Program or Calibrate; Battery Problem; Material Integrity Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE NOT RESPONDING. CUSTOMER STATED THE INSULIN PUMP HAD BATTERY LIFE LASTING UNDER A WEEK, REJECTED NEW BATTERIES AND BATTERY CAP STRIPPED AND HARD TO SECURE. 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 10384189 ↗
• MalfunctionAug 5, 2020Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD LOST SETTING AND HAD SEIZED, RAINBOW EFFECT ON THE SCREEN. CUSTOMER STATED THAT THE REWINDING WAS LOUD AND INSULIN PUMP REJECTED 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 10367080 ↗
• MalfunctionAug 5, 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 THE INSULIN PUMP HAD REJECTED NEW BATTERY, BUTTONS WERE HARDER TO PUSH, REWIND/ PRIME WAS SLOWER, AND THE INSULIN PUMP 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 10366320 ↗
• MalfunctionAug 4, 2020Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WAS DIM AND HARD TO READ. 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 10361972 ↗
• InjuryAug 4, 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. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 600 MG/DL. CUSTOMER STATED THAT THE INFORMATION OF THEIR METER WAS NOT SENDING TO THE INSULIN PUMP AFTER PULLING UP ACCOUNT. CUSTOMER ALSO STATED THAT THEY DID BOLUS DURING CALL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10360767 ↗
• MalfunctionAug 4, 2020Failure to Cycle; Priming Problem; Failure to Cycle; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND IT STARTED ALARMING THEN THE INSULIN WAS SQUIRTING OUT. 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 10360466 ↗
• MalfunctionJul 30, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Insufficient Device Problem Information; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT BUTTONS OF INSULIN PUMP HAD TO PRESS MULTIPLE TIMES. CUSTOMER STATED THAT INSULIN PUMP HAD UNSPECIFIED INSULIN PUMP ERROR ALARM AND UNEXPLAINED RANDOM NO DELIVERY ALARM. CUSTOMER STATED THAT INSULIN PUMP WAS STOPPED IN MIDDLE OF REWIND AND IT TAKES LOUDER 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 10343206 ↗
• MalfunctionJul 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR AND WHEN CHANGING BATTERIES HAD TO RESET DATE AND TIME. 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 10342792 ↗
• MalfunctionJul 30, 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 WERE HARD TO PRESS. CUSTOMER STATED THAT THE SCREEN WAS HARD TO READ. CUSTOMER STATED THAT THE TIME WAS ADVANCING. 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 10342672 ↗
• MalfunctionJul 30, 2020Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DRIVE SUPPORT CAP WAS DAMAGED. CUSTOMER STATED THAT THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER STATED THAT THE RESERVOIR AND INSULIN PUMP DOES NOT SHOW SIGNS OF DAMAGE. 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 10342669 ↗
• 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

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE. THE CUSTOMER¿S LOW BLOOD GLUCOSE WAS 45 MG/DL AND HIGH BLOOD GLUCOSE WAS 300 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10342635 ↗
• MalfunctionJul 29, 2020Mechanical Problem; Priming Problem; Mechanical Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM DURING THE PRIMING PROCESS. THE CUSTOMER STATED THAT SOMETIMES THE PUMP STOPS THE PRIMING PROCESS AND THE CUSTOMER HAS TO COMPLETELY REDO THE PRIMING PROCESS. CUSTOMER DECLINED TO PROVIDE THEIR BLOOD GLUCOSE. 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 10337486 ↗
• MalfunctionJul 24, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK BUT WORKING. 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 10318601 ↗
• MalfunctionJul 23, 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 KEYPAD ANOMALY. CUSTOMER STATED THE INSULIN PUMP'S ACT BUTTON WAS NOT REGISTERING PROPERLY WHEN PRESSING DOWN AND HAD TO PRESS TWICE AND SLOWER 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 10313875 ↗
• MalfunctionJul 22, 2020Display or Visual Feedback Problem; Overheating of Device; Display or Visual Feedback Problem; Overheating of Device

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BACKLIGHT OF INSULIN PUMP SCREEN WAS NO LONGER WORKING AND IT WAS NOT BRIGHT ENOUGH TO SAW. THE CUSTOMER STATED THAT INSULIN PUMP BECOME HOT WHILE REWINDING. CUSTOMER PERFORMED SELF TEST AND IT WAS PASSED. 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 10307707 ↗
• MalfunctionJul 22, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD ACT, UP AND DOWN BUTTONS ARE HARDER TO PRESSED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT THEY RECEIVED UNEXPLAINED NO DELIVERY ALARM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10307038 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND INSULIN DELIVERY TEMPORARILY STOPPED. 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 10306690 ↗
• MalfunctionJul 21, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE LESS RESPONSIVE. 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 10306016 ↗
• InjuryJul 21, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE IN EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE ON UNKNOWN DATE WITH UNKNOWN BLOOD GLUCOSE LEVEL. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD MOTOR ERRORS AND UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10300710 ↗
• MalfunctionJul 17, 2020No Display/Image; Mechanical Problem; Insufficient Flow or Under Infusion; Power Problem; No Display/Image; Mechanical Problem; Insufficient Flow or Under Infusion; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT WORKING AT ALL AND NOT GIVING INSULIN. ALSO HAD UNEXPLAINED NO DELIVERY ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10288299 ↗
• MalfunctionJul 14, 2020Mechanical Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. INSULIN PUMP HAD NO DELIVERY ALARM. INSULIN PUMP FAILED BATTERY TEST ALARM. CUSTOMER STATED THAT THE BATTERY CAP WAS CRACKED. 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 10269942 ↗
• MalfunctionJul 14, 2020Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Priming Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY AND INSULIN WAS SQUIRTING OUT DURING PRIME. THE CUSTOMER REPORTED THAT, THE BUTTONS CAN BE STICKY AND NON RESPONSIVE. THE CUSTOMER STATED THAT, THE SCREEN WAS BLANK HOWEVER BATTERY CAP WAS DAMAGED AND ALSO INSULIN PUMP HAD UNEXPLAINED 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 10269683 ↗
• MalfunctionJul 13, 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 THE INSULIN PUMP'S BUTTONS WERE HARDER TO PRESS. CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED UNEXPLAINED OR RANDOM NO DELIVERY ALARMS REGULARLY AND ENDS UP CHANGING SET. CUSTOMER HAD TO REWOUND THE INSULIN PUMP PER RESERVOIR CHANGE ALSO RECEIVED FAILED BATTERY TEST AND BATTERIES WERE REJECTED. 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 10262618 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120010. One submission often covers many models, so check the product and lot details in each record.

• 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