MiniMed® 530G MMT-551NAH (UDI 00643169503632)Recalls & reported problems

Summary

The FDA's MAUDE database contains 671 adverse event reports that list this exact device (DI 00643169503632), received between May 17, 2017 and Sep 22, 2020 — classified as 2 deaths, 234 injuries, 435 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (137 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 671 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM DURING BOLUS. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10565834 ↗
• MalfunctionSep 2, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S RETAINER RING WAS LOOSENED. RESERVOIR WAS ABLE TO LOCK INTO 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 10486348 ↗
• MalfunctionJul 30, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER REPORTED 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 10344046 ↗
• MalfunctionJul 29, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Priming Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A SQUIRTS INSULIN WHEN PRIMING, STICKY AND UNRESPONSIVE BUTTONS, UNEXPLAINED NO DELIVERY ALARMS, NO LOW BATTERY WARNING AND FAILED BATTERY TEST. THE CUSTOMER STATED THE ISSUES REMAINED UNRESOLVED. 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 10337041 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 476 MG/DL AND 236 MG/DL. CUSTOMER REPORTED NOW HE GOT IT DOWN BY GIVING HER UNITS OF INSULIN BUT HE FOUND THAT THERE WAS NO INSULIN ON THE INSULIN PUMP. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10312959 ↗
• MalfunctionJul 21, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BLACK RING AROUND THE RESERVOIR COMPARTMENT WAS HANGING OUT AND THE TOP OF THE RESERVOIR COMPARTMENT WAS CRACKED OFF. CUSTOMER STATED THAT THE RESERVOIR DID LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 10300161 ↗
• MalfunctionJul 15, 2020Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCREEN OF INSULIN PUMP HAD BUTTON WAS HARDER TO PRESS AND INSULIN WAS SQUIRTED. CUSTOMER STATED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM AND BATTERY LIFE ABOUT A WEEK. CRACK ON INSULIN PUMP BATTERY COMPARTMENT AND LOWER 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 10275409 ↗
• MalfunctionJul 8, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP¿S BOLUS BUTTON WAS NOT WORKING, SQUIRTS INSULIN WHEN PRIMING AND WAS LOUD DURING 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 10244498 ↗
• MalfunctionJun 24, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK AND RECEIVED MOTOR ERROR ALARM. CUSTOMER STATED THE RESERVOIR LIP RING 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 10188105 ↗
• MalfunctionJun 23, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SQUIRTS INSULIN DURING PRIMING. 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 10183938 ↗
• MalfunctionJun 23, 2020Device Alarm System; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Device Alarm System; Mechanical Problem; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARM HARDER TO HEAR. CUSTOMER REPORTED THAT THE INSULIN PUMP REJECT NEW BATTERY, AND REWIND MULTIPLE TIME AND USE MORE INSULIN DURING PRIMING. 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 10183129 ↗
• MalfunctionJun 22, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ISSUE AND HAD CRACK ON SIDE AND EDGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10177978 ↗
• MalfunctionJun 22, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DEVICE WAS SQUIRTING INSULIN OUT DURING MANUAL PRIME PROCESS. THE DRIVE SUPPORT CAP APPEARS 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 10177940 ↗
• MalfunctionJun 18, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER STATED THAT HE DRIVE SUPPORT CAP APPEARS 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 10167670 ↗
• MalfunctionJun 8, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTON WAS UNRESPONSIVE. ALSO HAD CRACKS ON BATTERY COMPARTMENT, HAD RAINBOW EFFECT ON SCREEN AND SQUIRTED OUT INSULIN FROM CANNULA WHILE PRIMING. 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 10127740 ↗
• MalfunctionJun 8, 2020No Display/Image; Mechanical Problem; No Display/Image; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND WAS NOT WORKING. 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 10127300 ↗
• MalfunctionMay 28, 2020Display or Visual Feedback Problem; Mechanical Problem; Date/Time-Related Software Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Date/Time-Related Software Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CLOCK NEED TO BE REPROGRAMMED ONCE IN A WHILE. CUSTOMER REPORTED THAT BATTERY PORT WAS CRACKED AND REWIND WAS LOUDER AND SCREEN HAD RAINBOW EFFECT. 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 10097256 ↗
• MalfunctionMay 25, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE NOT WORKING. 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 10085210 ↗
• MalfunctionMay 12, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER BLOOD GLUCOSE AT THE TIME OF INCIDENT UNKNOWN. TROUBLESHOOT WAS NOT PERFORMED. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10046208 ↗
• MalfunctionMay 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PIECE OF PLASTIC WAS MISSING AND INSULIN PUMP HAD CRACK AROUND THE BATTERY. 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 10043743 ↗
• MalfunctionMay 11, 2020Failure to Cycle; No Apparent Adverse Event; Priming Problem; Failure to Cycle; No Apparent Adverse Event; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME. THE CUSTOMER STATED THAT 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 10042464 ↗
• MalfunctionMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY HAD HYPERGLYCEMIA AND THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10038112 ↗
• MalfunctionMay 8, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS ABLE TO COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10037504 ↗
• InjuryMay 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 REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 596 MG/DL AT THE TIME OF INCIDENT. CUSTOMER ALSO STATED THAT THE INSULIN PUMP RECEIVED INSULIN FLOW BLOCKED ALARM AND CANNULA WAS BENT. CUSTOMER DECLINED FOR TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10028152 ↗
• MalfunctionMay 4, 2020Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem

  INFORMATION INDICATED BY MEDTRONIC THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE INSULIN PUMP DID NOT HAVE MOISTURE DAMAGE. THE ISSUE WAS NOT RESOLVED. INSULIN PUMP WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020023 ↗

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