MiniMed® 530G MMT-551LNAL (UDI 00643169933019)Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00643169933019), received between Jan 23, 2018 and Oct 28, 2020 — classified as 1 death, 34 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (24 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 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER ALLEGED THAT INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVEL 350 MG/DL. CUSTOMER PERFORMED AND PASSED HIGH PRESSURE TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10745376 ↗
• InjuryJul 21, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 475 MG/DL. THE INSULIN PUMP HAD A NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301089 ↗
• MalfunctionJul 16, 2020Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PRIME FILL ANOMALY. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 10282368 ↗
• MalfunctionJul 10, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC A THAT THE BUTTONS NOT RESPONDING AND NOT ALLOWING TO NAVIGATE IN MAIN MENU ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD BEHAVIOR. NO HARM MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257135 ↗
• MalfunctionJun 29, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND BUTTONS ON INSULIN PUMP WERE SPORADIC. 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 10205676 ↗
• MalfunctionJun 26, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR ALARM. CUSTOMER STATED INSULIN DELIVERY HAS TEMPORARILY STOPPED TO ENSURE YOUR SAFETY. CUSTOMER STATED THAT INSULIN PUMP HAD NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER STATED THEY WERE UNSURE ABOUT THE DAMAGED TO DRIVE SUPPORT CAP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10199819 ↗
• MalfunctionJun 8, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY RECEIVED A NO DELIVERY ALARM. CUSTOMER DECLINED TO PROVIDE BLOOD GLUCOSE LEVEL. TROUBLESHOOTING WAS NOT COMPLETED FOR THE NO DELIVERY ALARM. IT WAS ALSO REPORTED THAT THE CUSTOMER HAD ISSUES WITH SHORTENED BATTERY LIFE AND BUTTONS THAT WERE HARD TO PRESS OR WERE STICKY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS. NO PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10131557 ↗
• MalfunctionMay 12, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR RING ON INSULIN PUMP WAS SLOWLY CRACKING OFF AND IT WAS STARTING TO SLIP OUT AT TIMES. 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 10048420 ↗
• MalfunctionMay 8, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK ON SCREEN. 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 10037605 ↗
• MalfunctionApr 24, 2020Excess Flow or Over-Infusion; Mechanical Problem; Insufficient Flow or Under Infusion; Excess Flow or Over-Infusion; Mechanical Problem; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP PISTON WAS STICKING OUT AND IT OVER DELIVERIES AND UNDER DELIVERIES ISSUE. CUSTOMER STATED THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL AND LOW BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE LEVEL AND GLUCOSE TABLET FOR LOW BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL AND LOW BLOOD GLUCOSE LEVEL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 9998739 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER¿S SON REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON APRIL 12 TO (B)(6) 2020 WITH BLOOD GLUCOSE OF 400 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH INSULIN PUMP. CUSTOMER STATED THEY CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS VOMITING. CUSTOMER PERFORMED HIGH PRESSURE TEST AND TEST PASS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Vomiting

  MAUDE report 9985061 ↗
• MalfunctionMar 31, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE O-RING WAS BROKEN AND RESERVOIR DID NOT 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 9902120 ↗
• MalfunctionMar 23, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS DAMAGED. RESERVOIR SIDE HAD CRACK. 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 9864338 ↗
• MalfunctionMar 11, 2020Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS TURNED OFF WITH A BATTERY CHANGE. 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 9816936 ↗
• MalfunctionMar 3, 2020Device Alarm System; Device Difficult to Program or Calibrate; Battery Problem; Device Alarm System; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WAS STUCK SOMETIMES AND UNRESPONSIVE. CUSTOMER STATED THAT BATTERY LIFE WAS DIMINISHED AND INSULIN PUMP DID NOT GAVE THE LOW RESERVOIR ALERT EVEN AFTER RESERVOIR WAS EMPTY. 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 9779115 ↗
• MalfunctionFeb 7, 2020Device 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

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD A CRACK, BUTTONS HAD TO BE PRESSED HARDER AND MULTIPLE TIME FOR RESPONSE AND UNEXPLAINED NO DELIVERY ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9680136 ↗
• MalfunctionJan 22, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A DAMAGED RETAINER RING. THE CUSTOMER STATED THAT THE RESERVOIR DOES NOT 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 9614920 ↗
• MalfunctionJan 9, 2020Mechanical 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 THE INSULIN PUMP HAD MOTOR ERROR AND BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN PUMP CRACK ON WHOLE SIDE OF RESERVOIR. INSULIN PUMP WAS MAKING GRINDING NOISE DURING REWIND AND IT WAS SLOWER TO REWIND. CUSTOMER STATED THAT THEY EXPERIENCED RANDOM AND UNEXPLAINED NO DELIVERY ALERTS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9568510 ↗
• MalfunctionNov 16, 2019Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT SOMETIMES BUTTONS OF INSULIN PUMP WAS STICK WHEN THEY PRESSED AND WAS UNRESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9332917 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 412 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THEY WOKE UP WITH BLOOD GLUCOSE 59 MG/DL THEN THEY TREATED WITH BOLUS AND BLOOD GLUCOSE GOES TO 370 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED SET.

  Patient problems: Hyperglycemia

  MAUDE report 9325184 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL BY THE CUSTOMER'S PARENT THAT THE CUSTOMER GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 30 MG/DL AT THE TIME OF THE INCIDENT. THE CALLER DID NOT MENTION HOW THE CUSTOMER WAS TREATED. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS BEING BELLIGERENT. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER WAS UNAVAILABLE AT THE TIME OF THE CALL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9254250 ↗
• InjuryOct 29, 2019Adverse 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 THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON OCTOBER 16, 2019 WITH BLOOD GLUCOSE OVER 500 MG/DL. THE CUSTOMER WAS TREATED WITH THE INSULIN. THE CUSTOMER HAD VOMITING. THE CUSTOMER DECLINED TO CONTINUE THE TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 9248910 ↗
• MalfunctionOct 25, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP WAS OVER DELIVERING INSULIN WHEN THE RESERVOIR IS LOW. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THE RESERVOIR TUBE LIP THREADING WAS WORN. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9236937 ↗
• MalfunctionOct 9, 2019Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN SQUIRTS WHILE PRIMING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THAT THE THERE WAS CHIPPING ON THE RESERVOIR. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9171896 ↗
• MalfunctionOct 5, 2019Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN SQUIRTED OUT OF INFUSION SET WHEN PRIMING INSTEAD OF DRIP. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE EDGE OF INSULIN PUMP WAS DISCOLORED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9159557 ↗

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