MiniMed® 530G MMT-551LNAS (UDI 00643169933033)Recalls & reported problems

Summary

The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 00643169933033), received between Dec 14, 2017 and Sep 19, 2021 — classified as 76 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (47 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 223 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2021Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER REPORTED CRACK ON THE BATTERY COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12493575 ↗
• MalfunctionAug 7, 2020Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem; Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN HAD RAINBOW EFFECT ON SCREEN AND SCREEN WAS HARDER TO READ. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER HAD TO REWIND DOUBLE. 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 10378357 ↗
• MalfunctionJul 29, 2020Visual Prompts will not Clear; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Visual Prompts will not Clear; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RESERVOIR AREA WAS BUSTED AND INSULIN PUMP WAS FROZEN. CUSTOMER STATED THERE WAS CRACK AT ESCAPE BUTTON AND ALSO RECEIVED UNEXPLAINED NO DELIVERY ALARMS. INSULIN PUMP LOST SETTING WHEN BATTERY CHANGE AND REJECT NEW BATTERY OFTEN. INSULIN PUMP REWIND MORE THAN ONCE PER PRIME. 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 10336550 ↗
• MalfunctionJul 27, 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 THE INSULIN PUMP HAD UP AND DOWN BUTTONS WERE HARD TO PRESS. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALARMS, CRACKS IN CASING OF INSULIN PUMP. 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 10325121 ↗
• MalfunctionJun 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE LIP RING ON INSULIN PUMP WAS BROKEN. TROUBLESHOOTING WAS DONE FOR COSMETIC DAMAGE. THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO 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 10126702 ↗
• MalfunctionMay 3, 2020Mechanical Problem; Mechanical Problem

  INFORMATION INDICATED BY MEDTRONIC THAT THE INSULIN PUMP RECEIVED A MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 350 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10019890 ↗
• InjuryMay 1, 2020Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AS WELL AS LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 40 MG/DL, 300 MG/DL. CUSTOMER REPORTED THAT INSULIN PUMP HAD BAD BATTERY ERROR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10018422 ↗
• MalfunctionApr 29, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SOMETIMES STUCK IN REWIND MODE. 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 10011579 ↗
• MalfunctionApr 14, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP BUTTONS WERE UNRESPONSIVE AND HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER MENTIONED THE PUMP WAS EXPOSED TO MOISTURE ONCE. THE CUSTOMER REPORTED GETTING SENSOR CALIBRATION ERRORS AND ISSUES WITH GOING HIGH WITH NO ALARMS, OR HIGH ALERTS WHEN THEY WERE NOT HIGH. TROUBLESHOOTING WAS NOT COMPLETED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9959882 ↗
• MalfunctionApr 14, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR LIP RING WAS FALLEN OFF. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN 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 9956105 ↗
• MalfunctionApr 13, 2020Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND REWIND TAKE LONGER. HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP HAD BATTERY ISSUE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9955166 ↗
• MalfunctionApr 9, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD ALL UNRESPONSIVE BUTTONS. CUSTOMER REPORTED INSULIN PUMP BECAME UNRESPONSIVE AT THAT TIME. CUSTOMER REPORTED 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 9946703 ↗
• MalfunctionApr 8, 2020Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND REWIND TAKE LONGER. HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP HAD BATTERY ISSUE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938547 ↗
• MalfunctionMar 11, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN WAS SQUIRTED FROM INFUSION SET WHEN 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 9816568 ↗
• MalfunctionMar 5, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE TOO EASY TO PRESS. CUSTOMER STATED THAT ITS LOOK LIKE THE OPPOSITE SIDE OF THE RESERVOIR WAS COMING APART. 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 9791385 ↗
• MalfunctionFeb 12, 2020No Apparent Adverse Event; Wireless Communication Problem; No Apparent Adverse Event; Wireless Communication Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9698714 ↗
• MalfunctionFeb 5, 2020Device Alarm System; Battery Problem; Power Problem; Priming Problem; Device Alarm System; Battery Problem; Power Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC THAT THE INSULIN PUMP WAS LOSING INSULIN AT THE TIME OF PRIME. CUSTOMER STATED THAT THE INSULIN PUMP WAS MAKING GRINDING NOISE DURING REWINDING. INSULIN PUMP REJECTED NEW BATTERY AND HAD NO DELIVERY ALARM. 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 9674794 ↗
• MalfunctionFeb 3, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THEY WERE UNABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS REPORTED 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 9662057 ↗
• MalfunctionFeb 3, 2020Device Difficult to Program or Calibrate; Date/Time-Related Software Problem; Device Difficult to Program or Calibrate; Date/Time-Related Software Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP LOSES CORRECT TIME QUICKLY AND MUST BE RESET AND THE BUTTONS WERE HARDER TO PRESS TO GET THE INSULIN PUMP TO FUNCTION. 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 9658589 ↗
• MalfunctionJan 29, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD A CRACK ON BATTERY COMPARTMENT DUE TO DROPPING IT AND IT WAS NO LONGER WORKING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9645400 ↗
• MalfunctionJan 27, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTON OF THE INSULIN PUMP NEED TO PRESS MORE THAN ONCE ON OCCASION OF REWIND OR PRIME. CUSTOMER REPORTED THAT THE RESERVOIR CHIPS OFF. 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 9630721 ↗
• MalfunctionJan 11, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ISSUE. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER WAS REPORTED THAT INSULIN PUMP HAD UNEXPLAINED RANDOM NO DELIVERY ALARMS, DECEASED BATTERY LIFE. IT WAS REPORTED THAT THE ACT BUTTON HAD TO PRESS HARD TO KEEP CONTACT ON IT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9579076 ↗
• InjuryJan 8, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 38 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED FOOD TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER ALLEGED PUMP OVER DELIVERY. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9563262 ↗
• InjuryJan 7, 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 THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 520 MG/DL AT TIME OF INCIDENT. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER STATED THAT THEY DID DISCONNECT FROM THE FROM THE QUICK RELEASE DURING SHOWER, BUT THEY COULD NOT RECONNECT IT. CUSTOMER REPORTED A PROBLEM WITH THE BATCH OF QUICKSET INFUSION SET. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9556800 ↗
• InjuryJan 7, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 490 MG/DL. INSULIN PUMP HAD MOTOR ERROR ALARM. DIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9556442 ↗

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