MiniMed® 530G MMT-551NAS (UDI 00643169404298)Recalls & reported problems

Summary

The FDA's MAUDE database contains 781 adverse event reports that list this exact device (DI 00643169404298), received between May 2, 2017 and May 23, 2022 — classified as 3 deaths, 213 injuries, 565 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (148 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 781 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BOTTOM OF INSULIN PUMP GOT DAMAGED BY PUSHED OUT ON BATTERY SIDE OF THE INSULIN PUMP BOTTOM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14467955 ↗
• MalfunctionFeb 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BOTTOM OF INSULIN PUMP WAS CRACKED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 11256833 ↗
• MalfunctionAug 12, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ERROR WHILE CHANGING THE INSULIN SET. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395913 ↗
• MalfunctionAug 10, 2020Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS CRACKED ON THE SCREEN AND THE SCREEN WAS BLACK WITH INK SHOWING UNDERNEATH. 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 10383544 ↗
• MalfunctionAug 3, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCED SENSOR SYSTEM ERROR ALARM DURING FILL TUBING. 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 10355176 ↗
• MalfunctionJul 8, 2020Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER STATED THERE WAS UNEXPLAINED OR RANDOM NO DELIVERY ALARM. CUSTOMER REPORTED THERE WAS HAIRLINE FRACTURE IN RESERVOIR AT THE THREADING. 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 10243830 ↗
• MalfunctionJun 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BATTERY BARELY STAY BATTERY COMPARTMENT AND PLASTIC HOUSING WAS DISINTEGRATING. 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 10210583 ↗
• MalfunctionJun 26, 2020Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR AFTER FALLING IN THE POOL. CUSTOMER STATED THE PUMP WAS VIBRATING WITHOUT AN ALARM OR ALERT. 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 10199213 ↗
• MalfunctionJun 16, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP UP BUTTON AND ESC BUTTON WERE NOT WORKING. CUSTOMER STATED TIME WAS ADVANCED. TROUBLESHOOTING WAS PERFORMED. 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 10156412 ↗
• MalfunctionJun 12, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE. THE CUSTOMER ALLEGES THAT THE INSULIN PUMP WAS UNDER DELIVERING BECAUSE MANUAL INJECTIONS BRING HER GLUCOSE DOWN. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10147321 ↗
• MalfunctionJun 8, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WERE HARDER TO PRESS. 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 10127851 ↗
• MalfunctionMay 28, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS UNRESPONSIVE. INSULIN PUMP BATTERY CASE WAS BROKEN OFF. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10095366 ↗
• MalfunctionMay 28, 2020Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED BUTTON ERROR ALARM. CUSTOMER OBSERVE TIME CLOCK FOR ONE MINUTE AND TIME NOT ADVANCES. CUSTOMER REPORTED THAT THE INSULIN PUMP MONITOR FOR 3 MINUTES TO VERIFY TIME CLOCK WORKS PROPERLY AND FROZEN DISPLAY OR ALARMS DO NOT REOCCURRED. 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 10094845 ↗
• MalfunctionMay 20, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP STARTED BEEPING WHILE WORKING AND RECEIVED AN INSULIN PUMP ERROR ALARM. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT 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 10073585 ↗
• MalfunctionApr 28, 2020Failure to Cycle; Device Difficult to Program or Calibrate; Battery Problem; Failure to Cycle; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND BUTTON ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10003912 ↗
• MalfunctionApr 14, 2020Premature Discharge of Battery; Mechanical Problem; Obstruction of Flow; Battery Problem; Premature Discharge of Battery; Mechanical Problem; Obstruction of Flow; Battery Problem

  IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED WITH UNEXPECTED RESTART. A COLD RESET WAS PERFORMED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER'S INSULIN PUMP ALSO REJECTED NEW BATTERIES, NO DELIVERY ALERTS, AND LOUDER MOTOR SOUNDS. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957670 ↗
• MalfunctionApr 13, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY CHANGED OUT BATTERIES AND THE INSULIN PUMP SCREEN SHOWED IT REST AND THE BUTTONS WERE NOT RESPONDING. THE CUSTOMER REPORTED THAT THE ONE BUTTON WORKED AFTER REPLACEMENT BATTERY AND RECEIVED A UNEXPECTED RESTART. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND WERE ABLE TO COMPLETE THE REWIND PROCESS. THEY RECEIVED THE ALARM EVEN AFTER TROUBLESHOOTING. 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 9955329 ↗
• MalfunctionApr 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR OPENING AND BATTERY COMPARTMENT OPENING WAS MISSING. 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 9927697 ↗
• MalfunctionApr 6, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BUTTONS LESS RESPONSIVE AND BUTTONS WERE HARDER TO PRESS. THE CUSTOMER STATED THAT THE INSULIN PUMP SLOWER DURING REWIND AND 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 9927518 ↗
• MalfunctionApr 3, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING SEATING THE FORCE SENSOR DID NOT DETECT THE RESERVOIR. IT WAS REPORTED THAT THE CUSTOMER W AS TREATED MANUALLY. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9920041 ↗
• MalfunctionMar 27, 2020Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR COMPARTMENT HAD MISSING PIECES. CUSTOMER STATED THAT RESERVOIR CAN BE LOCKED IN PLACE WHEN INSERTED IN THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND THAT THEY WERE ABLE TO REWOUND. CUSTOMER ALSO STATED THAT 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 9892417 ↗
• MalfunctionMar 24, 2020Obstruction of Flow; Material Integrity Problem; Power Problem; Patient Device Interaction Problem; Obstruction of Flow; Material Integrity Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SMALL CHUNK OF BATTERY CAP WAS BROKE OFF AND INSULIN PUMP REJECTED NEW BATTERIES. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD UNEXPLAINED AND RANDOM NO DELIVERY ALARMS AND THERE WERE SCRATCHES ON SCREEN. 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 9870838 ↗
• MalfunctionMar 20, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PART WHERE THE RESERVOIR LOCKS IN BROKE OFF AND THE RUBBER CAME OFF. CUSTOMER DECLINED DAMAGED INSULIN PUMP TROUBLESHOOTING AND STATED SHE WANTED TO CONTINUE USING 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 9858585 ↗
• MalfunctionMar 13, 2020Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. TIME WAS ADVANCING AND KEYPAD WAS NOT RESPONDING. 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 9828288 ↗
• InjuryMar 6, 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 WERE HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVEL ON (B)(6) 2016. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 35 MG/DL. CUSTOMER HAD SEIZURE WHEN CUSTOMER DID NOT WOKE UP DUE TO LOW BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED IN THE EMERGENCY MEDICAL SERVICES FOR LOW BLOOD GLUCOSE LEVEL. CUSTOMER DID NOT ALLEGED THAT THE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER HAD BRITTLE DIABETIC AND THAT EVENT CAUSED LOW BLOOD GLUCOSE LEVEL. CUSTOMER WAS UNABLE TO CONFIRM THAT THE DRIVE SUPPORT CAP WAS DAMAGED OR NOT AS THE INSULIN PUMP WAS LOST. CUSTOMER WAS DECLINED TO TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Coma; Hypoglycemia; Seizures; Shock, Insulin

  MAUDE report 9797272 ↗

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