MiniMed® 530G MMT-551NAB (UDI 00643169503625)Recalls & reported problems

Summary

The FDA's MAUDE database contains 970 adverse event reports that list this exact device (DI 00643169503625), received between May 30, 2017 and Jun 22, 2021 — classified as 3 deaths, 351 injuries, 616 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (198 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 970 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2021Mechanical Problem; Obstruction of Flow; Environmental Compatibility Problem; Power Problem; Mechanical Problem; Obstruction of Flow; Environmental Compatibility Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM, REJECTED NEW BATTERIES AND NO DELIVERY ALERTS. THE CUSTOMER STATED INSULIN PUMP WAS EXPOSED TO HIGH MAGNETIC FIELD AND DRIVE SUPPORT CAP WAS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12038789 ↗
• MalfunctionFeb 2, 2021Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR AND BUTTON ERROR. THE CUSTOMERS BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR, BUTTON ERROR ALARMS AND NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 11270007 ↗
• MalfunctionAug 10, 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 WAS GETTING MOTOR ERROR ALARMS. THE CUSTOMER STATED THEY WERE HAVING ISSUES WITH BATTERY LONGEVITY, FAILED BATTERY ALARMS, AND UNEXPLAINED NO DELIVERY ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384375 ↗
• MalfunctionAug 7, 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

  CONFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARDER TO PRESS. INSULIN PUMP HAD NO DELIVERY ALARM. INSULIN PUMP REJECTED NEW BATTERIES. INSULIN PUMP HAD TO REWIND MORE THAN ONCE. 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 10378216 ↗
• MalfunctionAug 7, 2020Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM, UNEXPLAINED NO DELIVERY ALERTS, CHIPPED AT THE BATTERY CASING AND LITTLE LOUDER DURING THE 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 10377964 ↗
• MalfunctionAug 3, 2020Device Alarm System; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Device Alarm System; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE STICKY, HAD UNEXPLAINED NO DELIVERY ALARMS, NO LOW BATTERY WARNING AND HAD CRACK ON THE BACK ON THE INSULIN PUMP. 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 10355124 ↗
• MalfunctionJul 31, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE MOTOR ERROR AND MOTOR POSITION ENCODER ALARM AND ALSO HAD KEYPAD ANOMALY AFTER MOISTURE EXPOSURE. THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER STATED THAT, THE INSULIN PUMP STUCK IN THE REWIND PROCESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10348685 ↗
• MalfunctionJul 30, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER STATED THE TUBING WAS NOT BENT OR KINKED. CUSTOMER TRIED ALL THE REMEDIES. 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 10342878 ↗
• InjuryJul 23, 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 HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS ON UNKNOWN DATE WITH UNKNOWN BLOOD GLUCOSE LEVEL. THE CUSTOMER WAS EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10315970 ↗
• MalfunctionJul 23, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS HARD TO PRESS. CUSTOMER STATED THAT THE INSULIN PUMP LOUDER DURING REWIND AND ALSO HAD MINOR CRACK. 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 10312384 ↗
• MalfunctionJul 22, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SQUIRTING OUT INSULIN VERY FAST DURING PRIMING AND WAS NOT LIKE NORMAL. 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 10306879 ↗
• MalfunctionJul 21, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NOT 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 10301706 ↗
• MalfunctionJul 9, 2020No Display/Image; Moisture or Humidity Problem; Patient Device Interaction Problem; No Display/Image; Moisture or Humidity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THAT INSULIN PUMP EXPOSED TO MOISTURE AND DAMAGED. 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 10249057 ↗
• MalfunctionJul 8, 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 HARDER TO PRESS. 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 10243645 ↗
• InjuryJun 25, 2020Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 467 MG/DL. THE CUSTOMER WAS TREATED WITH THE MANUAL INJECTION. THE INSULIN PUMP HAD COMPROMISED SENSOR SYSTEM ALARM. THE TROUBLESHOOTING WAS PERFORMED FOR THE PRIME REWIND. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10193435 ↗
• MalfunctionJun 22, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE STICKY AND HAD TO PRESS MULTIPLE TIMES. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARMS AND CHANGES BATTERIES EVERY COUPLE OF 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 10178070 ↗
• MalfunctionJun 19, 2020Failure to Cycle; Detachment of Device or Device Component; Priming Problem; Failure to Cycle; Detachment of Device or Device Component; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER WAS PRIMING THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10173396 ↗
• InjuryJun 15, 2020Premature Discharge of Battery; No Display/Image; No Apparent Adverse Event; Intermittent Communication Failure; Premature Discharge of Battery; No Display/Image; No Apparent Adverse Event; Intermittent Communication Failure

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 452 MG/DL. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN PUMP. THE CUSTOMER WAS NOT USING THE INSULIN PUMP WITHIN 48 HOURS OF HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE CUSTOMER WAS REPORTED THAT THE INSULIN PUMP HAD BLANK DISPLAY. DISPLAY RETURNED AFTER CLEANING THE BATTERY CAP. INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10152911 ↗
• MalfunctionJun 8, 2020Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTON HARDER TO PRESSED AND REJECTED NEW BATTERIES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127630 ↗
• MalfunctionJun 8, 2020Mechanical Problem; Priming Problem; Mechanical Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY DID NOT PASS THROUGH THE RESERVOIR AND TUBING. CUSTOMER REPORTED THAT THEY WERE STUCK IN REWIND COMPLETE OR BOLUS DELIVERY LOOP. CUSTOMER STATED THAT THEY DID NOT RECEIVE 2ND SERIES OF BEEPS NOR DID NUMBERS APPEARED ON THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127317 ↗
• MalfunctionJun 5, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED INSULIN PUMP WAS ABLE TO CLEAR ALARM HOWEVER NOT ABLE TO REWIND THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10122343 ↗
• InjuryJun 2, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 100 MG/DL. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ALLEGING INSULIN PUMP FOR OVER DELIVERING BECAUSE CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10107548 ↗
• MalfunctionMay 27, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. 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 10090550 ↗
• MalfunctionMay 26, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS WERE HARD TO PRESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT THEY NEED TO CHANGE THE BATTERY MORE FREQUENTLY AND RECEIVE NO DELIVERY ALERTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086119 ↗
• MalfunctionMay 23, 2020Mechanical Problem; Battery Problem; Power Problem; Priming Problem; Mechanical Problem; Battery Problem; Power Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN SHOOT OUT OF THE CANNULA. CUSTOMER STATED THE INSULIN PUMP WAS SLOWER AND LOUDER DURING REWIND, LOW BATTERY ALARM AND THEN IN ONE HOUR NO POWER 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 10084618 ↗

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