MiniMed® 530G MMT-551LNAH (UDI 00643169933002)Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00643169933002), received between Jan 4, 2018 and Jul 19, 2020 — classified as 23 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (13 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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2020Device Difficult to Program or Calibrate; Material Integrity Problem; Moisture or Humidity Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Moisture or Humidity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN GETTING CLOUDY MAKING IT HARDER TO READ. CUSTOMER REPORTED THAT THE BUTTON WAS HARD TO PRESS AND ISSUES WITH BATTERY CAP GETTING JAMMED. 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 10293721 ↗
• MalfunctionMay 6, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER ALSO STATED THAT, THERE WERE DAMAGE UNDER THE BUTTON AND TOP BATTERY LIP. 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 10027476 ↗
• MalfunctionMay 1, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER STATED THAT THE BUTTONS WERE NOT RESPONDING. IT WAS REPORTED THAT THE TIME WAS ADVANCING. 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 10016919 ↗
• InjuryJan 3, 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 HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. CUSTOMER WAS TREATED WITH THE BOLUS. THE CUSTOMER WAS DECLINED THE TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9542438 ↗
• MalfunctionDec 31, 2019Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN WAS COMING OUT TOO FAST ALMOST LIKE A STREAM OR SQUIRT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9534086 ↗
• MalfunctionNov 19, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ACT AND UP ARROW BUTTONS WERE STUCK AND ALSO STATED THAT DOWN ARROW KEY WAS STICKING BUT NOT AS BAD AS ACT AND UP BUTTON. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT MOTOR WAS SLOWER AND LOUDER DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9340442 ↗
• InjuryNov 5, 2019Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) WITH BLOOD GLUCOSE OF 800 MG/DL. THE CUSTOMER WAS TREATED MANUAL INJECTION OF INSULIN. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD BATTERY OUT LIMIT ALARM BUT TEST WAS PASS AND ABLE TO REWIND THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9277075 ↗
• MalfunctionOct 12, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT RESERVOIR LIP RING HAD CRACK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK INTO PLACE. 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 9183532 ↗
• InjuryOct 5, 2019Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 426 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARM AND INSULIN WAS EXITED. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9159949 ↗
• MalfunctionAug 19, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Obstruction of Flow; Premature Discharge of Battery; Device Difficult to Program or Calibrate; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT ACT BUTTONS ON INSULIN PUMP WERE STICKING. CUSTOMER¿S BLOOD GLUCOSE WAS 100 MG/DL. CUSTOMER ALSO REPORTED THAT INSULIN PUMP ALARMED FOR NO DELIVERY DURING BASAL OR BOLUS AND INSULIN PUMP HAD UNEXPECTED RESTART EVEN AFTER BATTERY CHANGE. CUSTOMER STATED THAT TIME CLOCK WAS ADVANCING WHILE OBSERVING FOR 1 MINUTE. 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 8904727 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE IN (B)(6) 2019 WITH BLOOD GLUCOSE OF 40 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 153 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS GIVEN INTRAVENOUS FLUIDS TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THIS WAS A PAST EVENT. THE CUSTOMER MENTIONED ISSUES WITH THEIR INFUSION SET CONNECTOR LOCKING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS, BUT THE INFUSION SET WILL BE RETURNED.

  Patient problems: Hypoglycemia

  MAUDE report 8796951 ↗
• InjuryJun 28, 2019Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED VIA PHONE CALL THAT THE THEY EXPERIENCED HYPERGLYCEMIA ALSO INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 582 MG/DL. CUSTOMER STATED THEY DID NOT FEEL OKAY TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED SET.

  Patient problems: Hyperglycemia

  MAUDE report 8742927 ↗
• MalfunctionJun 26, 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 ALARMS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS THEY WERE UNABLE TO CLEAR THE ALARM BUT ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATES ALARM DID NOT OCCUR SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER ALSO HAS A SENSOR NOT CONNECTED ALERT AND WENT THROUGH THE SEARCH FOR SENSOR BUT DECIDED TO JUST CHANGE THE SENSOR BECAUSE THEY DID NOT WANT TO GET ANY ALARM DURING BEDTIME. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8734416 ↗
• MalfunctionJun 25, 2019Battery Problem; Patient Device Interaction Problem; Priming Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT DURING PRIMING THE INSULIN PUMP SQUIRTS OUT INSULIN INSTEAD OF DRIPPING. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE BATTERY LIFE LASTING ONLY A MONTH. THE CUSTOMER DECLINED TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8729977 ↗
• MalfunctionMay 29, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP ACT BUTTON DID NOT ALWAYS RESPOND. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD CRACKS IN THE CASING, BATTERY CAP BOTH ENDS AND RESERVOIR CRACKED AND NO DELIVERY RESULTING IN A SITE CHANGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8649147 ↗
• MalfunctionMay 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 THE INSULIN PUMP HAD A MOTOR ERROR AND UNEXPLAINED NO DELIVERY ALARM THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8614825 ↗
• MalfunctionMay 9, 2019Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Battery Problem; 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 THE UP AND DOWN BUTTON AND LIGHT BUTTON HAS TO PUSH HARD AND ALSO HAD CRACK WHERE RESERVOIR GOES IN ABOUT THREADING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8593899 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 506 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE OF THE PATIENT IS UNKNOWN. CUSTOMER ALSO STATES THAT CRACKED ON THE RESERVOIR COMPARTMENT. CUSTOMER STATES RESERVOIR UNABLE TO LOCK IN PLACE. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8526266 ↗
• MalfunctionApr 17, 2019No Display/Image; Device Difficult to Program or Calibrate; Power Problem; No Display/Image; Device Difficult to Program or Calibrate; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS NEEDS TO BE PRESSED MULTIPLE TIMES BEFORE WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. TROUBLESHOOTING WAS PERFORMED FOR CRITICAL PUMP ERROR. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8521758 ↗
• MalfunctionApr 17, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE GETTING STUCK AND HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED TO 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 8521415 ↗
• MalfunctionApr 11, 2019Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD KEYPAD ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD SUDDEN POWER DOWNS WITH NO LOW BATTERY WARNING, REJECTED NEW BATTERIES, DIMINISHED BATTERY LIFE SINCE DAY 1 USE, LOST DATE AND TIME WITH BATTERY CHANGE, STICKY, NON-RESPONSIVE BUTTONS. THE TROUBLESHOOTING WAS DECLINED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503200 ↗
• MalfunctionApr 3, 2019Date/Time-Related Software Problem; No Apparent Adverse Event; Date/Time-Related Software Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD TIME CLOCK ANOMALY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 126 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATES THAT THE CLOCK WAS LOSING TIME. CUSTOMER STATED THAT THE INSULIN PUMP HAD BATTERY OUT LIMIT AND THEY WERE ABLE TO CLEAR THE ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8477481 ↗
• MalfunctionFeb 14, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE UP AND DOWN ARROW BUTTONS WERE NOT WORKING PROPERLY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED TO 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 8341618 ↗
• MalfunctionJan 16, 2019Moisture or Humidity Problem; Patient Device Interaction Problem; Moisture or Humidity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT BATTERY COMPARTMENT AND SCREEN WAS CRACKED. BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT INSULIN PUMP WAS EXPOSED TO MOISTURE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8251790 ↗
• MalfunctionDec 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD COSMETIC DAMAGE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8140974 ↗

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