MiniMed® 530G MMT-551NAH (UDI 00643169404267)Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 00643169404267), received between Jun 1, 2017 and Aug 7, 2020 — classified as 1 death, 58 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (32 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 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2020Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED A BATTERY OUT LIMIT ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND DID NOT RECEIVE REQUEST TO COMPLETE THE REWIND PROCESS. IT WAS ADVISED THAT THE CAUSE OF THE ALARM WAS DUE TO A DAMAGED BATTERY CAP. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. 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 10377505 ↗
• InjuryAug 3, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE AND HIGH BLOOD GLUCOSE. THE CUSTOMER LOW BLOOD GLUCOSE LEVEL WAS 42 MG/DL AND HIGH BLOOD GLUCOSE LEVEL WAS 320 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 193 MG/DL. CUSTOMER STATED THAT THEY INSTALLING NEW BATTERY, MONITORING INSULIN PUMP FOR 2 HOURS AND FROZEN DISPLAY RECURRED. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR LOW BLOOD GLUCOSE AND HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10355731 ↗
• InjuryApr 9, 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¿S MOTHER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF OVER 400 MG/DL. THE CUSTOMER TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS DECLINED FOR HIGH BLOOD GLUCOSE. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9942619 ↗
• MalfunctionApr 4, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A STUCK IN NO DELIVERY WHEN TRYING TO CHANGE THE INFUSION SET. CUSTOMER STATED THAT THE INSULIN DID EXIT. 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 9925964 ↗
• MalfunctionMar 30, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. INSULIN PUMP HISTORY SHOWED MOTION SENSOR TEST FAILURE ALARM. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND INSULIN PUMP AS WELL. 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 9896726 ↗
• MalfunctionFeb 12, 2020Premature Discharge of Battery; Mechanical Problem; Premature Discharge of Battery; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND UNEXPECTED RESTART ALARM. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE BOTH ALARMS. CUSTOMER STATED THEY ARE UNABLE TO 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 9703615 ↗
• MalfunctionJan 27, 2020Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM, NO DELIVERY ALARM AND CRACKED AROUND THE RESERVOIR CASING. CUSTOMER STATED THAT THE RESERVOIR WAS LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER ALSO STATED THAT BACK LIGHT DID NOT WORK. CUSTOMER STATED THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER STATED THE INFUSION SET AND RESERVOIR DID NOT SHOW SIGNS OF DAMAGE. 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 9630835 ↗
• InjuryJan 26, 2020Mechanical Problem; Obstruction of Flow; No Apparent Adverse Event; Mechanical Problem; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO UNKNOWN REASON ON AN UNKNOWN DATE. CUSTOMER¿S BLOOD GLUCOSE READING WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARMS AND WOULD NOT DELIVER INSULIN AS WELL AS UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9630595 ↗
• MalfunctionDec 6, 2019Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SHOT INSULIN DURING PRIMING PROCESS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE RESERVOIR CASE WAS CHIPPED AND HAD SCRATCHES ON SCREEN. CUSTOMER DECLINED HELPLINE TRANSFER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9421283 ↗
• MalfunctionNov 25, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED THE MOTOR POSITION ENCODED ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 149 MG/DL. CUSTOMER STATED THAT FORGOT TO REMOVE HER PUMP WHILE UNDERGOING MRI. CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9367804 ↗
• MalfunctionNov 20, 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 BUTTONS WERE LESS RESPONSIVE, SOMETIMES ACT BUTTON HAD TO PRESS TWICE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ALSO REPORTED THAT INSULIN PUMP HAD REJECTED NEW BATTERY, SLOWER DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346754 ↗
• MalfunctionNov 18, 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 WAS 106 MG/DL. THE TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE CUSTOMER STATED THAT THE ALARM WAS OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED AND 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 9339479 ↗
• MalfunctionNov 11, 2019Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  THE CUSTOMER¿S PARENT REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 60 MG/DL AT THE TIME OF INCIDENT. CUSTOMER¿S PARENT STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND THE BUTTONS WERE UNRESPONSIVE. NO SIGNIFICANT EVENTS LEADING TO BUTTON ERROR WERE OBSERVED. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. THE CUSTOMER¿S PARENT WAS ADVISED TO HAVE THE CUSTOMER DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9303555 ↗
• MalfunctionNov 7, 2019Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER INQUIRED VIA PHONE CALL ON HOW TO DETERMINE SENSITIVITY. CUSTOMER WAS ADVISED TO CONSULT THEIR HEALTHCARE PROVIDER ABOUT SENSITIVITY. CUSTOMER'S BLOOD GLUCOSE VALUE WAS NOT PROVIDED. CUSTOMER HAS RECEIVED A NEW GENERATION PUMP. THE CUSTOMER RETURNED THE OLD DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291571 ↗
• MalfunctionOct 12, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE PART WHERE THE RESERVOIR SCREWS IN OF INSULIN PUMP HAD CHUNKS AND COMING OFF FROM LIP RING AREA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE RESERVOIR ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9183567 ↗
• MalfunctionSep 24, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE INSULIN PUMP REWIND DUE TO INSULIN PUMP ALARM. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO DISCONTINUE USE OF THE INSULIN PUMP AND REFER TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9108045 ↗
• InjurySep 5, 2019Mechanical Problem; Detachment of Device or Device Component; No Apparent Adverse Event; Mechanical Problem; Detachment of Device or Device Component; No Apparent Adverse Event

  THE CUSTOMER¿S FATHER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA; THE INSULIN PUMP HAD A MOTOR ERROR ALARM, AND THE DRIVE SUPPORT CAP WAS PUSHING OUT THE END OF THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ADVISED TO ENSURE THEY ARE DISCONTINUED FROM THE INSULIN PUMP AND FOLLOW THEIR MEDICALLY PRESCRIBED BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8963521 ↗
• MalfunctionJul 22, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Material Integrity Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Material Integrity Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE BUTTONS WERE LESS RESPONSIVE, SCRATCHES ON DISPLAY OF INSULIN PUMP AFFECTED ABILITY TO READ THE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT IN CASING AT BATTERY CAP AND RESERVOIR AREA OF INSULIN PUMP HAD CRACK, SLOWER DURING PRIME, RANDOM UNEXPLAINED NO DELIVERY ALERTS, SLOWER DURING REWIND, DIMINISHED BATTERY LIFE. THE CUSTOMER WAS ADVISED TO REPLACE AND 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: Hyperglycemia

  MAUDE report 8810617 ↗
• MalfunctionJul 18, 2019Device 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

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY AND FAILED BATTERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE INSULIN PUMP REJECTED NEW BATTERY, BUTTONS WERE LESS RESPONSIVE AND ALSO HAD RANDOM NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8801326 ↗
• MalfunctionJul 9, 2019Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP HAD A BUTTON ERROR AND SHE COULD NOT CLEAR IT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING. 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 8770280 ↗
• InjuryJul 4, 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 LEVEL OF 505, 469 AND 493 MG/DL. THE CUSTOMER DID NOT PROVIDE THE SYMPTOMS REGARDING HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8762983 ↗
• MalfunctionJun 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. TROUBLESHOOTING FOR BUTTON ERROR/KEYPAD ANOMALY WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE ACT BUTTON WAS UNRESPONSIVE. THE CUSTOMER ALSO STATED THAT THERE WAS NO SIGNIFICANT EVENT LEADING TO THE KEYPAD ISSUES. THE CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING AND ADVISED THAT THEY WILL JUST MONITOR THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8715439 ↗
• MalfunctionJun 14, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS WERE SLOW TO RESPOND TO COMMANDS AND INSULIN PUMP HAD CODE ERRORS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE MOTOR SOUND DURING REWIND, CHANGING BATTERIES EVERY 2 WEEKS AND OFTEN REJECTS NEW BATTERIES. THE CUSTOMER ALSO STATED THAT INSULIN PUMP HAD NO DELIVERY ALARM AND LARGE CRACKS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8698962 ↗
• MalfunctionJun 13, 2019No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY AND CRACK ON THE RESERVOIR COMPARTMENT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 220 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS NOT ASSISTED WITH TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695066 ↗
• MalfunctionMay 27, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE HALF OF RESERVOIR OPENING WAS BROKEN. 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 8643938 ↗

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