MiniMed® 530G MMT-551LNAP (UDI 00643169933026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00643169933026), received between Jan 24, 2018 and Jul 3, 2020 — classified as 16 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (10 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE INSULIN 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 10229245 ↗
• MalfunctionJul 1, 2020Mechanical Problem; Material Integrity Problem; Power Problem; Mechanical Problem; Material Integrity Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED MOTOR ERROR WHEN RESERVOIR WAS EMPTY INSTEAD OF NO DELIVERY. 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 10216967 ↗
• MalfunctionMay 6, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS, PLASTIC PIECES BREAK OFF OF THE RESERVOIR AND HAD SMALL HAIRLINE FRACTURES AT THE VERY TOP OF WHERE THE RESERVOIR GOES IN AND CLICKS RIGHT ABOVE THE RUBBER 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 10030613 ↗
• InjuryApr 22, 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 HAD EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE LEVEL OF 498 MG/DL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED WITH MANUAL INJECTION FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER REPORTED THAT THEY HAD CONTACTED THEIR HEALTH CARE PROFESSIONAL. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE LEVEL. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATED THAT THE DRIVES SUPPORT CAP WAS NORMAL. THE DEVICE WILL BE RETURNED FOR ANALYSIS WHILE THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Nausea

  MAUDE report 9986723 ↗
• MalfunctionApr 15, 2020Display or Visual Feedback Problem; Priming Problem; Display or Visual Feedback Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SQUIRTED INSULIN DURING PRIMING AND RAINBOW EFFECT ON SCREEN. 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 9961438 ↗
• MalfunctionMar 4, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP BUTTONS WERE STUCK AND UNRESPONSIVE. 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 9784427 ↗
• MalfunctionFeb 10, 2020Application Program Version or Upgrade Problem; Application Program Version or Upgrade Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD NEW SOFTWARE RELEASE DETECTED ALARM. CUSTOMER RECEIVED A SECOND NEW SOFTWARE RELEASE DETECTED AFTER CLEARING THE 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 9685610 ↗
• MalfunctionDec 5, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  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 THEY CHANGED BATTERIES MORE OFTEN THAN ORIGINALLY AND STICKY BUTTONS LEAD TO MISINFORMATION AND SMALL CRACK IN DISPLAY SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9414738 ↗
• MalfunctionNov 27, 2019Device Alarm System; Mechanical Problem; Device Difficult to Program or Calibrate; Device Alarm System; Mechanical Problem; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTON WAS LESS RESPONSIVE AND HARDER TO PRESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND CUSTOMER BACK ON INJECTIONS DUE TO INSULIN PUMP MALFUNCTIONING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9388070 ↗
• MalfunctionNov 13, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  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 ACT BUTTON WAS STUCK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313982 ↗
• MalfunctionOct 29, 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 BUTTON WAS HARDER TO PRESS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. INSULIN PUMP HAD NO DELIVERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9248983 ↗
• InjuryOct 16, 2019Adverse 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 WERE HOSPITALIZE DUE TO HIGH BLOOD GLUCOSE LEVEL WITH DIABETIC KETOACIDOSIS ON (B)(6) 2019. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 560 MG/DL, AT THE TIME OF HOSPITALIZATION. CUSTOMER HAD VOMITING AND POSITIVE KETONES TEST. CUSTOMER WAS TREAT WITH INSULIN DRIP AFTER ADMISSION. CUSTOMER DECLINED TO CONTINUE THE TROUBLESHOOTING FOR POSSIBLE CAUSE OF HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Vomiting

  MAUDE report 9196298 ↗
• MalfunctionOct 3, 2019Premature Discharge of Battery; Mechanical Problem; Obstruction of Flow; Premature Discharge of Battery; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN UNEXPECTED RESTART WHEN THEY PUT A NEW BATTERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP RECEIVED RANDOM NO DELIVERY ALARM AND REWIND PROCESS TAKES LONGER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9149611 ↗
• MalfunctionOct 2, 2019Device Alarm System; Power Problem; Device Alarm System; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S BATTERIES ARE NOT LASTING, NOT GETTING A LOW NOTIFICATION AND DIED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER DID NOT HEAR LOW BATTERY ALARM. THE CUSTOMER WAS ASSISTED WITH ABSENCE OF ALARM. THE CUSTOMER PERFORMED SELF TEST AND IT PASSED. CUSTOMER STATED DOES NOT HEAR OR FEEL THE LOW BATTERY WARNING AND JUST DIES. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9143764 ↗
• MalfunctionSep 9, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD TO PRESS BUTTON TWICE AND GOES BACK AND FORTH WITH IT TO WORK. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. IT WAS ALSO REPORTED THAT INSULIN PUMP RECEIVED NO DELIVERY ALARMS TWICE AND BATTERY DRAINED WHEN IT IS NEW. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8973545 ↗
• MalfunctionJun 7, 2019Premature Discharge of Battery; Premature Discharge of Battery

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART, A COLD RESET WAS PERFORMED AS WELL AS EXTERNAL RAM CRC ERROR AS WELL AS LOW BATTERY ALERT. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT THEY WERE ABLE TO COMPLETE REWIND. CUSTOMER STATES THAT ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE DEVICE WILL BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678842 ↗
• MalfunctionMay 16, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RESERVOIR COMPARTMENT WAS VERY HARD TO SCREW IN, SCRATCH TO SCREEN OBSTRUCTING VIEW, BUTTONS WERE STICKY OR NON RESPONSIVE, PRIME OR REWIND MORE THAN ONCE, NO DELIVERY ALARM AND E ERROR CODE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8614521 ↗
• InjuryMay 7, 2019Obstruction of Flow; Priming Problem; Obstruction of Flow; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WERE 574 MG/DL TO 36 MG/DL. THE CUSTOMER ALSO REPORTED OTHER BLOOD GLUCOSE VALUES SUCH AS OVER 200 MG/DL. THE CUSTOMER WAS REPORTED THAT THE INSULIN SQUIRTED DURING PRIMING. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8585033 ↗
• MalfunctionMar 27, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP BUTTONS WERE HARD TO PRESS. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455399 ↗
• MalfunctionMar 27, 2019Device Alarm System; Mechanical Problem; Battery Problem; Power Problem; Device Alarm System; Mechanical Problem; Battery Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN VIBRATE ANOMALY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP DID NOT VIBRATE TO ALERTS. THEY ALSO REPORTED COSMETIC DAMAGE AND BATTERY ISSUES. INSULIN PUMP WILL NOT RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8454944 ↗
• MalfunctionMar 18, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CHUNK OF PLASTIC MISSING BETWEEN THE RESERVOIR AND BATTERY COMPARTMENT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO STATED THAT THE LOCATION OF DAMAGE WAS ON TOP OF PUMP BETWEEN THE RESERVOIR AND BATTERY COMPARTMENT. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428290 ↗
• MalfunctionMar 18, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT O RING WAS HALF THERE AND TOP PART WAS CHIPPING OFF OF RESERVOIR COMPARTMENT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER REPORTS DAMAGE TO THE PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428124 ↗
• InjuryMar 7, 2019Premature Discharge of Battery; No Display/Image; Battery Problem; No Apparent Adverse Event; Unexpected Shutdown; Premature Discharge of Battery; No Display/Image; Battery Problem; No Apparent Adverse Event; Unexpected Shutdown

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED THE MULTIPLE PUMP ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 369 MG/DL. THE CUSTOMER STATED THAT INSULIN PUMP WAS NOT WORKING. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED AND THE DISPLAY DID NOT RETURNED. THE CUSTOMER STATED THAT THE CONTACT ON THE BATTERY CAP WAS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER STATED THAT THE SELF TEST WAS PASSED. THE CUSTOMER RECEIVED ANOTHER UNEXPECTED RESTART ALARM AFTER THE TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8398089 ↗
• MalfunctionMar 7, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 285 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED THAT THEY HAD UNEXPECTED RESTART ALARM AND WAS ABLE TO COMPLETE REWIND. IT WAS REPORTED THAT THE TROUBLESHOOTING WAS PERFORMED AND RECEIVED ANOTHER UNEXPECTED RESTART ALARM AFTER A BATTERY CHANGE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8398068 ↗
• MalfunctionMar 5, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  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 NOT RESPONDING ON THE INSULIN PUMP AND NO PREVIOUS ISSUES WITH THE PUMP IT WASN'T DROP OR BUMPED. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8390258 ↗

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