MiniMed® 530G MMT-551NAP (UDI 00643169404281)Recalls & reported problems

Summary

The FDA's MAUDE database contains 325 adverse event reports that list this exact device (DI 00643169404281), received between Jun 1, 2017 and Aug 24, 2023 — classified as 3 deaths, 75 injuries, 247 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (82 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 325 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2023Failure to Cycle; Failure to Cycle

  MEDTRONIC RECEIVED INFORMATION THAT THE INSULIN PUMP HAD AN A33 ALARM (COMPROMISED FORCE SENSOR SYSTEM). NO FURTHER DETAILS WERE PROVIDED. CUSTOMER HAS RECEIVED A NEW INSULIN PUMP AND NO REPLACEMENT NEEDED. NO DEVICE IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608917 ↗
• MalfunctionNov 9, 2021Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S RETAINER RING WAS MISSING. CUSTOMER STATED THAT INSULIN PUMP HAD COSMETIC DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783948 ↗
• MalfunctionSep 9, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS CHIPPED OFF. CUSTOMER STATED THAT THE BELT CLIP AREA WAS CHIPPED. 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 10505994 ↗
• MalfunctionJun 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 A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE DEVICE WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM AND THE DRIVE SUPPORT CAP APPEARS PROTRUDED. 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 10113794 ↗
• MalfunctionApr 6, 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 A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS LOOSE. 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 9927967 ↗
• MalfunctionMar 9, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED BUTTON ERROR. IT WAS ALSO REPORTED THAT TIME DID NOT ADVANCED ON 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 9804547 ↗
• MalfunctionFeb 13, 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 A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE DRIVE SUPPORT CAP STICKING OUT. 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 9705262 ↗
• MalfunctionJan 22, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WOULD STICK AND WERE HARD TO PRESS AT TIMES. THE CUSTOMER STATED THAT THE SCREEN HAD ISSUES AS WELL AS HAD DIMINISHED BATTERY LIFE. THE INSULIN PUMP WOULD MAKE GRINDING NOISE WHEN REWINDING. 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 9614446 ↗
• MalfunctionJan 9, 2020Mechanical 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 THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT INSULIN PUMP WAS SLOWER DURING REWIND AND RECEIVED RANDOM NO DELIVERY ALARM. CUSTOMER STATED THAT PLASTIC CORNER ON BATTERY COMPARTMENT WAS BROKE OFF. THE DEVICE WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9568270 ↗
• MalfunctionJan 7, 2020Display or Visual Feedback Problem; Battery Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD TWO LINES ON SCREEN FROM THE INSIDE AND CAN¿T BE CLEANED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT BATTERIES WERE DYING QUICKER AND WHERE BATTERY GOES IN, PART OF PUMP CASING WAS MISSING. CUSTOMER DECLINED TECHNICAL SUPPORT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9556908 ↗
• MalfunctionJan 3, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTON ERROR AND BUTTONS WERE NOT RESPONDING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT TIME CLOCK WAS ADVANCING. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO 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 9542509 ↗
• MalfunctionDec 23, 2019Device Difficult to Program or Calibrate; Material Integrity Problem; Power Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Power 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 BUTTONS WERE UNRESPONSIVE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9510051 ↗
• MalfunctionDec 5, 2019Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR WAS CHIPPED AROUND AND WHERE THE BATTERY GOES IN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT INSULIN PUMP HAD NO DELIVERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9421166 ↗
• MalfunctionDec 4, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device 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 ARROW BUTTONS WERE STICKING PUMP. IT WAS REPORTED THAT THEY HAD GRINDING NOISE WHEN IT REWINDS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9409405 ↗
• MalfunctionDec 3, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9400218 ↗
• MalfunctionNov 25, 2019Display or Visual Feedback Problem; Obstruction of Flow; Battery Problem; Display or Visual Feedback Problem; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DISPLAY WAS HARD TO READ. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED BATTERIES LASTED LESS THAN 7 DAYS HAPPENED SEVERAL TIME AND HAD UNEXPLAINED AND RANDOM NO DELIVERY ALARMS ONCE A MONTH CUSTOMER STATED THEY CHANGED INFUSION SET AND ERROR STOPPED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9373125 ↗
• MalfunctionNov 22, 2019Device Difficult to Program or Calibrate; Use of Device Problem; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Obstruction of Flow; 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 BUTTONS WERE NOT RESPONSIVE AND ALSO HAD DIMINISHED BATTERY LIFE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9363092 ↗
• MalfunctionNov 12, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Appropriate Device Problem Term/Code Not Available; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SEVERAL ISSUES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A BATTERY LIFE AND BACK LIGHT ISSUE, AND BUTTONS WERE HAD TO PUSH. CUSTOMER DECLINED TROUBLESHOOTING. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9308158 ↗
• InjuryNov 6, 2019Failure to Cycle; Insufficient Flow or Under Infusion; No Apparent Adverse Event; Failure to Cycle; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AS WELL AS INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 409 MG/DL AT THE TIME OF INCIDENT AND FASTING 170 MG/DL. CUSTOMER WAS TREATED WITH SYRINGE. CUSTOMER STATED THAT SHE TOOK FOUR UNITS BUT BELIEVES INSULIN WAS NOT DELIVERED. CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. TROUBLESHOOTING WAS PERFORMED FOR INSULIN PUMP ERROR ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9283292 ↗
• MalfunctionOct 1, 2019Obstruction of Flow; Battery Problem; Priming Problem; Obstruction of Flow; Battery Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SQUIRTED INSULIN WHILE PRIMING. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP RECEIVED BATTERY LIFE WAS DIMINISHED AND RANDOM NO DELIVERY ALARMS. CUSTOMER REPORTED THAT THE EVENT WAS RESOLVED BY CHANGING COMPLETE SET. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9140030 ↗
• MalfunctionSep 19, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM DURING REWIND. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9085454 ↗
• MalfunctionSep 13, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A COMPROMISED FORCED SENSOR SYSTEM ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY WERE CHANGING SITE AND DOING REWIND WHEN THE ALARM OCCURRED. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT UNABLE TO REWIND THE INSULIN PUMP. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9036873 ↗
• MalfunctionSep 2, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE BECAME UNRESPONSIVE AND HAS TO PUSH TWICE. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE INSULIN PUMP WAS CRACKED AT BATTERY AND RESERVOIR COMPARTMENT. THE CUSTOMER ALSO STATED THAT THE RESERVOIR LIP RING WAS DAMAGED. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED THE RESERVOIR DID LOCK IN PLACE. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8953305 ↗
• MalfunctionAug 28, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S KEYPAD WAS LESS RESPONSIVE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE RESERVOIR COMPARTMENT HAD CHIPPED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8939156 ↗
• MalfunctionAug 23, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 317 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT NUMBERS WERE RAMPING ON THE INSULIN PUMP AND ALL THE BUTTONS WERE AFFECTED. THE CUSTOMER STATED THAT THE TIME WAS ADVANCING. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924888 ↗

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