MiniMed® 530G MMT-551NAS (UDI 00643169503663)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,944 adverse event reports that list this exact device (DI 00643169503663), received between May 2, 2017 and Jul 15, 2021 — classified as 5 deaths, 818 injuries, 2,121 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (689 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 2,944 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2021Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE KEYPAD OF THE INSULIN PUMP IS NOT WORKING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12171596 ↗
• MalfunctionMay 28, 2021Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT THE INSULIN WAS LEAKED INSIDE THE INSULIN PUMP. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO CLEAR THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 11901076 ↗
• MalfunctionDec 1, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING HAD MISSING PIECES AND BATTERY COMPARTMENT WAS CRACKED. CUSTOMER REPORTED THAT THE RESERVOIR WAS ABLE TO LOCKING IN PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10925666 ↗
• MalfunctionNov 19, 2020Obstruction of Flow; Battery Problem; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE POOR BATTERY LIFE AND RANDOM NO DELIVERY ALARMS. 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 10866921 ↗
• MalfunctionOct 18, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PIECE OF PLASTIC CASING WAS MISSING AROUND THE BATTERY COMPARTMENT. 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 10695062 ↗
• MalfunctionOct 15, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP REWIND SLOWER THAN IT HAD IN THE PAST AND HAD A CRACK BY THE BATTERY SENSORS WAS NOT CONNECTING TO 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 10683163 ↗
• MalfunctionOct 8, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS DEEP CRACK IN THE RESERVOIR PART THAT EXTENDS ALL THE WAY TO THE ESCAPE BUTTON. CUSTOMER STATED THAT THERE WAS SCRATCHES ON THE BOTTOM PART OF THE 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 10646847 ↗
• MalfunctionOct 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BROKEN BATTERY COMPARTMENT. TROUBLESHOOTING WAS DONE FOR COSMETIC 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 10646738 ↗
• MalfunctionOct 1, 2020No Display/Image; Material Integrity Problem; Patient Device Interaction Problem; No Display/Image; Material Integrity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THAT THE CONTACTS ON THE BATTERY CAP ARE 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 10611211 ↗
• MalfunctionSep 29, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK UPPER RIGHT HAND OF SCREEN AND THEY RECEIVED RANDOM NO DELIVERY ALARMS. 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 10598000 ↗
• MalfunctionSep 22, 2020Communication or Transmission Problem; Communication or Transmission Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER WAS CALLING FOR THE WARRANTY DATE. 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 10565382 ↗
• MalfunctionSep 11, 2020Mechanical Problem; Moisture or Humidity Problem; Patient Device Interaction Problem; Mechanical Problem; Moisture or Humidity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD CASING CRACKED AND CONCERNED OF WATER DAMAGE, LOUD TO REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10519673 ↗
• InjurySep 8, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY A CUSTOMER'S ATTORNEY INDICATES THAT A CUSTOMER SUFFERED HYPOGLYCEMIA THAT RESULTED IN A SEIZURE ON (B)(6) 2017. THE ATTORNEY STATES THAT THE CUSTOMER HAD A MALFUNCTION FROM THEIR INSULIN PUMP THAT CAUSED AN OVER DELIVERY OF INSULIN TO THE CUSTOMER. THE CUSTOMER WAS FOUND UNCONSCIOUS AND UNRESPONSIVE AND WAS RUSHED TO THE EMERGENCY ROOM BY PARAMEDICS. THE ATTORNEY STATES THAT THE CUSTOMER SEVERE BRAIN TRAUMA DUE TO THE INCIDENT AND REQUIRED SURGICAL PROCEDURES. THE CUSTOMERS SYMPTOMS AND BLOOD GLUCOSE LEVELS AT THE TIME OF THE EVENT WERE NOT PROVIDED. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Loss of consciousness; Seizures

  MAUDE report 10505832 ↗
• MalfunctionAug 12, 2020Mechanical Problem; Detachment of Device or Device Component; Priming Problem; Mechanical Problem; Detachment of Device or Device Component; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND THE DRIVE SUPPORT CAP WAS PROTRUDED. ALSO THERE WAS ISSUES WITH THE PRIMING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395206 ↗
• MalfunctionAug 12, 2020Loss of Data; Detachment of Device or Device Component; Priming Problem; Loss of Data; Detachment of Device or Device Component; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED INSULIN PUMP ERROR ALARM, HAD ISSUES WITH PRIMING AND THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 10395165 ↗
• MalfunctionAug 11, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE HARDER TO PRESS. CUSTOMER DID NOT ANSWER TO 24 HOURS HELPLINE. 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 10390372 ↗
• MalfunctionAug 11, 2020Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP DID NOT REWIND WHEN BATTERY WAS LOW. CUSTOMER STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALARMS. INSULIN PUMP BACKLIGHT SOMETIME DID NOT RESPOND. INSULIN PUMP REJECTED BRAND NEW BATTERY AND BATTERY LIFE WAS DIMINISHED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10389429 ↗
• MalfunctionAug 11, 2020Device Alarm System; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Alarm System; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WAS SCRATCHED AND HARD TO READ. CUSTOMER STATED THAT THE BUTTONS OF THE INSULIN PUMP WAS UNRESPONSIVE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT THE BATTERY LIFE DIMINISHED NOT LESS THAN 7 DAYS. 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 10389408 ↗
• MalfunctionAug 10, 2020Display or Visual Feedback Problem; Obstruction of Flow; Connection Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR OF INSULIN PUMP DID NOT CLICK IN TO PLACE. THE CUSTOMER STATED THAT THE BACKLIGHT OF INSULIN PUMP DID NOT ALWAYS WORK AND HAD NO DELIVERY ALARMS. 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 10384403 ↗
• MalfunctionAug 10, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A STICKY BUTTONS AND SOMETIME BECAME STALLED. INSULIN PUMP REJECTED THE NEW BATTERIES AND RECEIVED UNEXPLAINED NO DELIVERY ALARMS. CUSTOMER HAD TO CHANGE THE BATTERIES EVERY WEEK. 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 10383679 ↗
• MalfunctionAug 10, 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 BUTTONS OF INSULIN PUMP WERE WORN. THE CUSTOMER STATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND REJECTED NEW BATTERIES. 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 10383462 ↗
• MalfunctionAug 7, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A LIGHT BUTTON STICKING ISSUES WITH BACKLIGHT DIMMER AND FEW UNEXPLAINED NO DELIVERY ALARMS. 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 10379646 ↗
• InjuryAug 7, 2020Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 480 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE VALUE WAS 132 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE VALUES WERE 140 MG/DL, 130 MG/DL AND OVER 500 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER REPORTED THAT THEY RECEIVED NO DELIVERY ALARM. CUSTOMER REPORTED THAT THE EVENT WAS RESOLVED BY INFUSION SET. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10379558 ↗
• MalfunctionAug 7, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER REPORTED THAT INSULIN PUMP HAD A TINY CRACK NEAR THE ESCAPE BUTTON GOING TOWARD THE RESERVOIR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10377717 ↗
• MalfunctionAug 7, 2020No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY AND NOT TURNING ON. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. CUSTOMER STATED THAT THE BUTTONS WERE NOT RESPONSIVE. INSULIN PUMP FAILED SELF TEST. 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 10377696 ↗

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