MiniMed® 530G MMT-551LNAB (UDI 00643169507692)Recalls & reported problems

Summary

The FDA's MAUDE database contains 370 adverse event reports that list this exact device (DI 00643169507692), received between May 10, 2017 and Aug 3, 2020 — classified as 166 injuries, 204 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (57 reports).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 370 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTION SENSOR TEST FAILURE ALERT. 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 10354745 ↗
• MalfunctionJul 20, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DOWN BUTTON REQUIRES MULTIPLE OR LONGER PRESSES TO RESPOND. THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS AND BUTTONS WERE FADED. 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 10294361 ↗
• MalfunctionJul 16, 2020Date/Time-Related Software Problem; Battery Problem; Power Problem; Patient Device Interaction Problem; Date/Time-Related Software Problem; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD LOST DATE AND TIME DURING BATTERY CHANGE AND ALWAYS HAD TO RESET. ALSO REPORTED THAT IT REJECTED NEW BATTERIES, BATTERY LIFE HAD DECREASED FROM FIRST DAY, THERE WAS HAIRLINE CRACK NEAR RESERVOIR, UNEXPLAINED RANDOM NO DELIVERY, AND ALSO THERE WAS SCRATCHES ON SCREEN. 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 10281604 ↗
• MalfunctionJul 1, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD SEVERE SCRATCHED ON THE SCREEN. 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 10222432 ↗
• MalfunctionJun 4, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ESC AND ACT BUTTON NEED TO PRESS MULTIPLE TIMES TO WORK. 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 10117709 ↗
• MalfunctionMay 21, 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 WAS ABLE TO CLEAR BUT NOT ABLE TO REWIND THE INSULIN PUMP. 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 10078111 ↗
• InjuryMay 15, 2020Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT AND OTHER BLOOD GLUCOSE VALUE WAS 153 MG/DL. CUSTOMER REPORTED THAT THEY RECEIVED MOTOR ERROR ALARM. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID NOT RECEIVED MOTOR POSITION ENCODER ALARM. CUSTOMER STATED THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO COMPLETE REWIND THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10062474 ↗
• MalfunctionMay 12, 2020Failure to Cycle; Power Problem; Patient Device Interaction Problem; Failure to Cycle; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. TROUBLESHOOTING WAS NOT PERFORMED. CUSTOMER BLOOD GLUCOSE READING WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10045936 ↗
• InjuryApr 9, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 400 MG/DL AND 153 MG/DL. CUSTOMER STATED INSULIN PUMP HAD MOTOR ERROR. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9943600 ↗
• MalfunctionApr 9, 2020No Display/Image; Application Program Version or Upgrade Problem; Loss of Data; Patient Device Interaction Problem; No Display/Image; Application Program Version or Upgrade Problem; Loss of Data; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REPEATED INSULIN PUMP ERROR AND BLANK DISPLAY. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED INSULIN PUMP HAD CRACK CHIPPED PIECE. 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 9942735 ↗
• InjuryApr 4, 2020No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL. THE CUSTOMER STATED THAT THE CRACK ON BACK OF THE INSULIN PUMP, SCREEN AND BATTERY COMPARTMENT. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK INTO PLACE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9925762 ↗
• InjuryApr 4, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE BLOOD GLUCOSE OF THE CUSTOMER WAS 500 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT INSULIN PUMP WAS CRACKED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9925760 ↗
• MalfunctionFeb 12, 2020Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED E CODE ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER STATED THE INSULIN PUMP WAS TURNED OFF AND ON TO GET FUNCTIONING AND DIMINISHED BATTERY LIFE, LASTING MORE THAN A WEEK. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9698789 ↗
• MalfunctionFeb 12, 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 INSULIN PUMP¿S BUTTONS WERE BECOMING HARDER TO PRESS, DIMINISHED BATTERY LIFE AND 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 9698767 ↗
• MalfunctionFeb 7, 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 ACTION BUTTON WAS HARDER TO PRESS. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS CRACKED AROUND BATTERY COMPARTMENT. 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 9681144 ↗
• MalfunctionJan 29, 2020Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP WAS OVER AND UNDER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GETTING HIGHS AND LOWS AND WAS GOING TO DISCONTINUE PUMP USE. NO FURTHER INFORMATION WAS PROVIDED. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 9640517 ↗
• MalfunctionJan 15, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS WERE LESS RESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT UP OR DOWN OR ACT BUTTONS WERE HARDER TO PRESS AND SOMETIMES HAS TO PRESS BUTTONS TWICE. THE CUSTOMER STATED THAT THE PISTON DELAY AT TIME WHEN CHANGING THE RESERVOIR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9589967 ↗
• MalfunctionDec 20, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS HARDER TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED INSULIN PUMP SLOWER AND LOUDER DURING REWIND. CUSTOMER STATED INSULIN PUMP BUTTONS SOMETIMES HAD TO PRESS TWICE. CUSTOMER ALSO STATED UNEXPLAINED NO DELIVERY ALERTS AND HAD CRACK AROUND THE RESERVOIR TREADING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9502393 ↗
• MalfunctionDec 12, 2019Failure to Cycle; Failure to Cycle

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 121 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. THE CUSTOMER WAS ADVISED TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9456930 ↗
• MalfunctionDec 12, 2019No Display/Image; No Display/Image

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9456520 ↗
• MalfunctionDec 9, 2019Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHES ON SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT INSULIN PUMP HAD CRACKED NEAR RESERVOIR, NO DELIVERY ALARMS IN PAST AND BATTERY LIFE LASTING ONLY TWO WEEKS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9442573 ↗
• MalfunctionDec 7, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR WHILE CHANGING RESERVOIR. CUSTOMER¿S BLOOD GLUCOSE WAS 320 MG/DL. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL AND INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9434690 ↗
• MalfunctionDec 6, 2019Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD INSULIN DELIVERY ISSUE AND INSULIN PUMP DID NOT NOTIFY WITH NO DELIVERY ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9427866 ↗
• MalfunctionDec 5, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ACT BUTTON REQUIRE MULTIPLE PRESS TO REGISTER IT. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9414608 ↗
• MalfunctionDec 4, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE BUTTONS WERE UNRESPONSIVE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9407972 ↗

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-1751-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 530G Insulin Pump (MMT-551, MMT-751)
• 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