MiniMed® 530G MMT-551LNAS (UDI 00643169507739)Recalls & reported problems

Summary

The FDA's MAUDE database contains 835 adverse event reports that list this exact device (DI 00643169507739), received between May 10, 2017 and Jun 24, 2021 — classified as 4 deaths, 314 injuries, 517 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (131 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 835 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2021Adverse Event Without Identified Device or Use Problem; Power Problem; Adverse Event Without Identified Device or Use Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD WEAK BATTERY ALARM AND WAS ABLE TO CLEAR THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12055779 ↗
• MalfunctionSep 8, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING HAD CRACK. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE. 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 10500559 ↗
• MalfunctionAug 21, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BATTERY CASE WILL NOT CLOSE WITHOUT RUBBER BAND. ENTIRE EDGE AROUND BATTERY COMPARTMENT WAS BROKEN OR CRACKED OR MISSING AND HELD TOGETHER WITH TAPE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10436375 ↗
• MalfunctionJul 24, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER ALSO STATED THAT THE CHUNKS OF THE BATTERY COMPARTMENT WAS MISSING. 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 10318966 ↗
• MalfunctionJul 22, 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 ISSUE AND REJECTED BRAND NEW BATTERIES. 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 10306993 ↗
• MalfunctionJul 16, 2020Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR 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 10281615 ↗
• InjuryJun 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

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED WITH MANUAL INJECTIONS. CUSTOMER CANNOT GET BELOW 500 MG/DL VALUE. CUSTOMER HAD STROKES DUE TO WHICH SHE FORGOT TO TAKE BOLUS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Stroke/CVA

  MAUDE report 10211952 ↗
• MalfunctionJun 30, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS STUCK IN REWINDING. 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 10210973 ↗
• InjuryJun 29, 2020Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS BELOW 500 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. IT WAS REPORTED THAT INSULIN PUMP HAD BUTTON ISSUE. THE CUSTOMER WAS REPORTED THAT BUTTONS HAD TO PRESS MULTIPLE TIMES; INSULIN PUMP HAD LITTLE SCRATCHES ON SCREEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10205657 ↗
• MalfunctionJun 23, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED A COMPROMISED FORCED SENSOR SYSTEM ERROR ALARM WHILE REWINDING. THE INSULIN PUMP WAS NOT DROPPED OR BUMPED AND THE DRIVE SUPPORT CAP APPEARED 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 10183493 ↗
• MalfunctionJun 9, 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 INSULIN PUMP HAD MOTOR ERROR ALARMS. THE CUSTOMER STATED THEY ALSO HAD PUMP PHYSICAL DAMAGE, FREQUENT NO DELIVERY ALARMS, AND UNRESPONSIVE PUMP BUTTONS. 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: Hyperglycemia

  MAUDE report 10131653 ↗
• MalfunctionJun 8, 2020Failure to Cycle; Patient Device Interaction Problem; Failure to Cycle; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER REPORTED THAT THEY WERE NOT ABLE 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 10126953 ↗
• MalfunctionJun 2, 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 BUTTONS WAS STICKING. THE INSULIN PUMP HAD STARCHES ON SCREEN WHICH MADE SCREEN HARD TO SEE. THE INSULIN PUMP RECEIVED RANDOM NO DELIVERY ALERT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10107587 ↗
• MalfunctionJun 1, 2020Obstruction of Flow; Battery Problem; Priming Problem; Obstruction of Flow; Battery Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SQUIRTING OUT INSULIN DURING THE PRIME PROCESS. THE CUSTOMER STATED THEY WERE GETTING RANDOM NO DELIVERY ALERTS, THE PUMP WAS LOSING SETTINGS WITH NEW BATTERY INSERTION, AND IT WAS TAKING A LONG TIME TO RESTART THE PUMP AFTER NEW BATTERY INSERTION. 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 10104452 ↗
• MalfunctionMay 21, 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 INSULIN PUMP'S ESC BUTTONS WAS STUCK SOMETIMES. CUSTOMER STATED THE INSULIN PUMP SCREEN WAS CRACKED AND OCCASIONAL UNEXPLAINED NO DELIVERY ALERTS. 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 10078226 ↗
• MalfunctionMay 15, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER HAD TO PRESS THE ACTION BUTTON VERY HARD TO PERFORM PRIME. CUSTOMER DID CONFIRM ABOUT THE TIME CLOCK THAT IT WAS ADVANCING. 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 10061149 ↗
• MalfunctionMay 1, 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 RECEIVED MOTOR POSITION ENCODER ALARM. CUSTOMER STATED THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO CLEAR ALARM AND ABLE TO COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10016689 ↗
• MalfunctionApr 30, 2020Device Alarm System; Battery Problem; Power Problem; Device Alarm System; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP FAILED TO GIVE NO DELIVERY ALARM AND REJECTED 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 10015606 ↗
• MalfunctionApr 27, 2020Premature Discharge of Battery; Patient Device Interaction Problem; Premature Discharge of Battery; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND WERE NOT ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD BROKEN AT THE BATTERY SIDE. 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 10003317 ↗
• MalfunctionApr 27, 2020Mechanical Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PLASTIC HAD CHIPPED OFF OF RESERVOIR. THE CUSTOMER ALSO STATED THAT INSULIN PUMP HAD LIGHT SCRATCHES ON SCREEN, NEW BATTERIES HAVE BEEN REJECTED ON OCCASION AND HAD RESET THERE INSULIN PUMP SETTINGS, REWIND WAS LOUDER HAD TO PRIME 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 10002829 ↗
• MalfunctionApr 24, 2020Display or Visual Feedback Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL FAILED BATTERY TEST AND DISPLAY SCREEN WAS DIFFICULT TO READ ON THE INSULIN PUMP. TROUBLESHOOTING WAS NOT PERFORMED. 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 9994853 ↗
• MalfunctionApr 9, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE HALF THE SCREEN IS GONE 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 9942091 ↗
• InjuryApr 7, 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 CALL THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL OF 40 MG/DL. CUSTOMER WAS TREATED WITH FOOD. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9932425 ↗
• InjuryApr 7, 2020Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER¿S HUSBAND REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 428 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT THEY TRIED TO BOLUS AND IT WAS GIVING A NO DELIVERY. CUSTOMER STATED INSULIN EXITED AT THE QUICK RELEASE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9932421 ↗
• MalfunctionApr 4, 2020Obstruction of Flow; Power Problem; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP REJECTED NEW BATTERY. INSULIN PUMP HAD RANDOM NO DELIVERY ALARM. INSULIN PUMP FORCED PATIENT TO CHANGE THE SET. 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 9925847 ↗

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