MiniMed® 530G MMT-551NAL (UDI 00643169736030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00643169736030), received between Jul 25, 2017 and Nov 22, 2020 — classified as 13 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (11 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING CAME OFF. CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO 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 10882045 ↗
• InjuryAug 6, 2020Environmental Compatibility Problem; Environmental Compatibility Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PARAMEDICS WAS CALLED ON AN UNKNOWN DATE DUE TO LOW BLOOD GLUCOSE LEVEL WITH AN UNKNOWN BLOOD GLUCOSE LEVEL. THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE CUSTOMER WAS UNRESPONSIVE TO HONEY SO THE PARAMEDICS TREATED WITH GLUCAGON AND THE CUSTOMER TREATED HIMSELF WITH FOOD. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE INSULIN PUMP WAS EXPOSED TO HIGH MAGNETIC FIELD. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 10372182 ↗
• MalfunctionJul 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HAD AND WERE GETTING STUCK. 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 10232467 ↗
• MalfunctionFeb 26, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY AND HAD HAIRLINE CRACK ON THE SCREEN OF 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 9755978 ↗
• MalfunctionJan 3, 2020Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT THE INSULIN SQUIRTING OUT OF CANNULA INSTEAD OF DRIPS AND REJECTED NEW BATTERIES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9543195 ↗
• MalfunctionDec 17, 2019Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP SCREEN HAD SCRATCHES AND WAS HARDER TO READ THE SCREEN DATA. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PUMP HAD TO REWOUND MORE THAN ONCE PER RESERVOIR CHANGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9480049 ↗
• MalfunctionNov 16, 2019Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THERE WAS CRACK ON RESERVOIR AREA, BATTERY AREA AND ON WINDOW. THE INSULIN PUMP HAD RANDOM UNEXPLAINED NO DELIVERY ALARM AND LOUDER REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9332805 ↗
• MalfunctionNov 11, 2019Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP DUE TO ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD NOT BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304531 ↗
• MalfunctionNov 7, 2019Display or Visual Feedback Problem; Overheating of Device; Device Difficult to Program or Calibrate; Obstruction of Flow; Moisture or Humidity Problem; Display or Visual Feedback Problem; Overheating of Device; Device Difficult to Program or Calibrate; Obstruction of Flow; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTON WAS HARDER TO PRESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALERTS, SOMETIMES BUTTONS PRESS TWICE AND SLOWER DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9289315 ↗
• MalfunctionSep 17, 2019Obstruction of Flow; Intermittent Communication Failure; Obstruction of Flow; Intermittent Communication Failure

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD SPI TO MOTOR PIC COMMUNICATION ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 254 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED THEY WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. CUSTOMER ASSISTED WITH PERFORMING A SELF TEST AND TEST WAS PASSED. CUSTOMER REPORTED THAT THEY GOT AGAIN INSULIN PUMP ERROR AFTER TROUBLESHOOTING. CUSTOMER REPORTED THEY WAS ABLE TO CLEAR THE ALARM. CUSTOMER NOT ABLE TO COMPLETE REWIND. 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 AS PER HEALTHCARE PROFESSIONAL INSTRUCTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076029 ↗
• InjurySep 10, 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 HAD A HIGH BLOOD GLUCOSE VALUE OF 400 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS DIZZY AND NOT FEELING WELL. THE CUSTOMER WAS TREATED WITH BOLUS. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8981743 ↗
• MalfunctionAug 26, 2019No Display/Image; Battery Problem; Power Problem; No Display/Image; Battery Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY AND UNEXPECTED POWER LOSS AND LOW BATTERY LIFE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THEY PLACED THE BATTERY CAP ON THE INSULIN PUMP SHOWED FULL BATTERY LIFE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8929123 ↗
• MalfunctionAug 15, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP'S BUTTONS WERE UNRESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS AND BATTERY LIFE ALSO DIMINISHED. CUSTOMER STATED THAT THE SCRATCHES ON THE SCREEN. CUSTOMER DECLINED TO SPOKE WITH TECHNICAL SUPPORT AFTER REVIEWING MALFUNCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8895997 ↗
• MalfunctionAug 6, 2019Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PARTIAL DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 105 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD SCREEN JUST BLACK AND THEY CAN NOT DO ANYTHING FURTHER. THE CUSTOMER STATED THAT THEY BACK STICKER HAD CAME OFF. 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8863762 ↗
• MalfunctionJul 16, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 140 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED. CUSTOMER STATED THE BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE SPRING WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THAT THE DISPLAY DID NOT RETURNED. 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 8792622 ↗
• MalfunctionJul 9, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD STOPPED WORKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 250 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED OR BUMPED. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8770255 ↗
• MalfunctionMay 23, 2019Failure to Cycle; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Failure to Cycle; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE BUTTONS WERE STICKY AND SOMETIME UNRESPONSIVE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEED TO BE REPLACED AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8635247 ↗
• InjuryApr 2, 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 EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 450 MG/DL. THE CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR AND RESERVOIR DID NOT LOCK INTO PLACE. THE CUSTOMER DID NOT PROVIDE INFORMATION ABOUT SYMPTOMS. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE VALUE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8472626 ↗
• MalfunctionMar 28, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS CRACKED FROM THE RESERVOIR COMPARTMENT. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 110 MG/DL. CUSTOMER REPORTED DAMAGE TO THE INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8459042 ↗
• MalfunctionMar 20, 2019Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PLASTIC THREADS WAS BREAKING OFF IN RESERVOIR COMPARTMENT AND UNEXPLAINED NO DELIVERY ALARM, HAS ALSO RECEIVED MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8435357 ↗
• MalfunctionMar 7, 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 WORKS INTERMITTENTLY, SOMETIMES IT WAS DELAYED AND SOMETIMES HAD TO PUSH IT SEVERAL TIMES TO GET IT TO WORK. 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 8398575 ↗
• MalfunctionFeb 21, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND NO REPORT OF PUMP SCREEN FLASHING WHEN SCREEN WAS TURNED ON AFTER BEING IN SLEEP MODE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE INSULIN PUMP NEED TO BE REPLACED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8360696 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Power Problem; Adverse Event Without Identified Device or Use Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED FOR A LOW BLOOD GLUCOSE OF 39 MG/DL ON (B)(6) 2019. THE CUSTOMER PASSED OUT AS A RESULT OF THE HYPOGLYCEMIA. THE CUSTOMER WAS TREATED WITH GLUCAGON. THE CUSTOMER ATTRIBUTED THE LOW TO AN INACCURATE SENSOR; THEIR SENSOR GLUCOSE READ 198 MG/DL DESPITE A BLOOD GLUCOSE OF 39 MG/DL. THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM DURING THE EVENT. ADDITIONALLY, THE CUSTOMER EXPERIENCED A HIGH BLOOD GLUCOSE OF 476 MG/DL. TROUBLESHOOTING DID NOT OCCUR ON THE INSULIN PUMP OR SENSOR. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. THE SENSOR WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8352781 ↗
• MalfunctionFeb 5, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD FELL AND SCREEN WAS CRACKED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 271 MG/DL. CUSTOMER STATED THAT THEY WAS NOT ABLE TO READ THE SCREEN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WILL NEED TO BE REPLACED AND DISCONTINUE USE OF THE INSULIN PUMP AND 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 8304101 ↗
• MalfunctionFeb 1, 2019Mechanical Problem; Obstruction of Flow; Priming Problem; Mechanical Problem; Obstruction of Flow; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN SQUIRTS DURING PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORT RANDOM NO DELIVERY ALARM AND MOTOR ERROR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8295890 ↗

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