MiniMed® 530G MMT-551NAS (UDI 00643169736054)Recalls & reported problems

Summary

The FDA's MAUDE database contains 226 adverse event reports that list this exact device (DI 00643169736054), received between Jun 2, 2017 and Oct 27, 2020 — classified as 1 death, 102 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (29 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 226 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS A CRACK ON BATTERY COMPARTMENT. 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 10741506 ↗
• MalfunctionAug 7, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE, NO DELIVERY ALARM, LOUDER DURING 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 10377946 ↗
• MalfunctionJul 21, 2020No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING DEVICE MALFUNCTION. NO FURTHER DETAILS GIVEN. RESERVOIR AND INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Loss of consciousness; No Consequences Or Impact To Patient

  MAUDE report 10304996 ↗
• MalfunctionJul 17, 2020Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER STATED THAT THERE WAS CRACK AT BOTTOM OF INSULIN PUMP. CUSTOMER STATED THAT RESERVOIR LIP RING WAS NOT 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 10287672 ↗
• MalfunctionJul 15, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF THE INSULIN PUMP WERE SLOW TO RESPOND AND THE INSULIN PUMP HAD 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 10275556 ↗
• InjuryJul 8, 2020Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 429 MG/DL. THE CUSTOMER¿S BLOOD GLUCOSE VALUE LEVEL AT THE TIME OF INCIDENT WAS 300 MG/DL. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS OF HIGH BLOOD GLUCOSE VALUE. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. BASED ON CUSTOMER¿S REPORT CUSTOMER DID NOT ALLEGE UNDER DELIVERY. THE CUSTOMER WAS USING THE INSULIN PUMP WHEN HIGH BLOOD GLUCOSE EVENT WAS REPORTED. THE CUSTOMER WAS REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10243416 ↗
• MalfunctionJun 29, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALERT. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER EXPERIENCED MULTIPLE ERRORS AFTER BATTERY CHANGE. 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 10205944 ↗
• MalfunctionJun 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RETAINER RING PART WAS CHIPPED. THE CUSTOMER STATED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 229 MG/DL AND TREATED WITH MANUAL INJECTION. CUSTOMER STATED THERE WAS PHYSICAL DAMAGE TO RETAINER RING AND RESERVOIR WAS ABLE TO LOCK IN PLACE. THE CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL DUE TO HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10204949 ↗
• MalfunctionMay 14, 2020Loss of Data; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AN INSULIN PUMP ERROR ALARM. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWIND THE 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 10055536 ↗
• MalfunctionApr 27, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP ALARMED WITH MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER WAS ABLE TO CLEAR ALARM AND ABLE TO REWOUND THE INSULIN. TROUBLESHOOTING WAS PERFORMED. ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER STATED THE INSULIN PUMP WAS NOT STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000065 ↗
• MalfunctionApr 11, 2020Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF THE INSULIN PUMP WERE STICKS. CUSTOMER STATED THAT THE INSULIN PUMP HAD A FAILED BATTERY TEST AND BATTERIES LAST TWO DAYS. 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 9951602 ↗
• MalfunctionApr 2, 2020Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP ERROR ALARM. NO HARM WAS REPORTED DURING THE INCIDENT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914764 ↗
• MalfunctionMar 3, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED INSULIN DID NOT CONTINUE TO DRIP AFTER LETTING GO OF THE ACT BUTTON. THE DRIVE SUPPORT CAP WAS 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 9783474 ↗
• MalfunctionFeb 27, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WAS UNRESPONSIVE. THE CUSTOMER STATED THAT TIME WAS ADVANCING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER STATED THAT THE UP BUTTON WAS NOT WORKING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9760871 ↗
• MalfunctionFeb 16, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP¿S PART WHERE THE RESERVOIR SCREWS IN THAT HAD COMPLETELY CAME OFF HOWEVER 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 9715464 ↗
• MalfunctionJan 12, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP NOT DELIVERING INSULIN AS MUCH INSULIN AS IT SUPPOSED TO DELIVERED. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9579453 ↗
• MalfunctionDec 27, 2019No Display/Image; Battery Problem; Patient Device Interaction Problem; No Display/Image; Battery Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS SHUT OFF FOR NO REASON. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT BATTERY LIFE WAS DIMINISHED AND CRACK NEAR RESERVOIR COMPARTMENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9522589 ↗
• MalfunctionDec 12, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP'S BUTTONS WERE HARD TO PRESS AND NEED TO PUT TOO MUCH PRESSURE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE TIME WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACKUP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9456619 ↗
• MalfunctionDec 11, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT UP AND DOWN ARROWS ARE GETTING HARD TO PUSH. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT TIME ADVANCED DURING THE KEYPAD ISSUE. 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 9451151 ↗
• MalfunctionDec 11, 2019Obstruction of Flow; Power Problem; Obstruction of Flow; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS POWERED OFF IMMEDIATELY AFTER BATTERY FAIL TEST. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES THE INSULIN PUMP RECEIVED REJECTED NEW BATTERY ALSO RECEIVED UNEXPLAINED NO DELIVERY ALARMS AND BATTERY FAIL ALERT. THE INSULIN PUMP WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9450060 ↗
• MalfunctionDec 9, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE NOT RESPONDING AND NEED TO PRESS BUTTONS MULTIPLE TIMES TO RESPOND. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE ESC BUTTON AND SOMETIMES THE ACT BUTTON DID NOT RESPOND LIKE THEY SHOULD. 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 DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9435644 ↗
• MalfunctionNov 20, 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 THE BUTTONS WERE LESS RESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ALSO REPORTED THAT INSULIN PUMP HAD DIMINISHED BATTERY LIFE, SOMETIMES CHANGING OUT BATTERY EVERY WEEK, RANDOM UNEXPLAINED NO DELIVERY ALARMS, PLASTIC OVER SCREEN WAS WEARING OFF. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346681 ↗
• MalfunctionNov 7, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE LEAKS INSULIN FROM RESERVOIR COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE CRACK ON BATTERY COMPARTMENT. THE RESERVOIR AND INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9293718 ↗
• MalfunctionNov 7, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP¿S ACT BUTTON WAS HARD TO PRESS AND NEED TO PRESS MORE THAN ONCE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALERT AND IT WAS SLOWER TO REWIND. IT WAS ALSO REPORTED THAT THERE WERE SCRATCHES ON SCREEN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9293131 ↗
• MalfunctionNov 1, 2019Obstruction of Flow; Patient Device Interaction Problem; Priming Problem; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SCREEN WAS HARD TO READ. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE LOW RESERVOIR WHEN IT¿S FULL, NO DELIVERY ALARMS OCCURS AND STRANGE REWIND NOISE WHEN PRIMING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265040 ↗

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