MiniMed® 530G MMT-551NAB (UDI 00643169404250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 259 adverse event reports that list this exact device (DI 00643169404250), received between Jun 2, 2017 and Jul 24, 2020 — classified as 80 injuries, 179 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (52 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 259 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2020No Display/Image; Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Moisture or Humidity Problem; No Display/Image; Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED KEYPAD ANOMALY AND FROZEN DISPLAY DUE TO WATER EXPOSURE. CUSTOMER CHANGED BATTERY BUT ISSUE NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10318924 ↗
• MalfunctionJul 15, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP WAS NORMAL. THE FORCE SENSOR WAS NO LONGER DETECTING RESERVOIR DURING SEATING. 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 10274382 ↗
• MalfunctionMar 9, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCED SENSOR SYSTEM ERROR WHEN TRYING TO REWIND. 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 9804576 ↗
• MalfunctionMar 4, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACKED AT 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 9784504 ↗
• MalfunctionDec 18, 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 AND IT DOES NOT RESPOND ANYMORE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 250 MG/DL. CUSTOMER ALSO ADVISED TO OBSERVED TIME CLOCK FOR ONE MINUTE TO VERIFY IF THE TIME ADVANCED. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT THE TIME WAS ADVANCED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9487319 ↗
• MalfunctionDec 4, 2019Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power 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 INSULIN PUMP REJECTED NEW BATTERIES, CRACK ALONG BATTERY COMPARTMENT, BUTTON ERROR AND HAD TO PRESS ESCAPE AND ACT BUTTON HARDER IN ORDER TO RESPOND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9408704 ↗
• MalfunctionNov 21, 2019Use of Device Problem; Power Problem; Use of Device Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DIMINISHED BATTERY LIFE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9353652 ↗
• MalfunctionNov 20, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR MAKES GRINDING NOISE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED INSULIN PUMP LOUDER DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9351621 ↗
• MalfunctionNov 20, 2019No Display/Image; Battery Problem; No Display/Image; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED. CUSTOMER STATED THAT THE BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED ALSO THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE DISPLAY RETURNED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9351070 ↗
• MalfunctionNov 15, 2019Device Difficult to Program or Calibrate; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UP ARROW BUTTON THAT WAS DIFFICULT TO PUSH. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE O RING WAS FALL OFF. THE INSULIN PUMP HAD REJECT BATTERY AND DAMAGED AT THE RESERVOIR STICK COMPARTMENT. INSULIN PUMP HAD SCREEN ERROR AND HAD UNKNOWN ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9326685 ↗
• MalfunctionNov 12, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Power Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Power Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE CUSTOMER HAD TO PRESS BUTTONS MORE THAN THE ONCE TO RESPOND . CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9308146 ↗
• MalfunctionNov 1, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A COMPROMISED FORCED SENSOR SYSTEM ALARM. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 230 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE INSULIN PUMP. THE DEVICE WILL RETURN FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265096 ↗
• MalfunctionOct 29, 2019Connection Problem; Power Problem; Patient Device Interaction Problem; Connection Problem; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. CUSTOMER¿S BLOOD GLUCOSE WAS 173 MG/DL . CUSTOMER STATED THAT INSULIN PUMP WAS NOT WORKING AND RESERVOIR COMPARTMENT WAS BROKEN AS WELL AS HAD MISSING PIECE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249006 ↗
• MalfunctionOct 23, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR LIP RING WAS CRACKED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE. CUSTOMER WAS REPORTED THAT THE INSULIN PUMP WAS CRACKED ON THE FRONT TO THE BOTTOM AND ON THE RESERVOIR COMPARTMENT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9222921 ↗
• InjurySep 25, 2019Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 48 MG/DL AT THE TIME OF INCIDENT AND TOOK JUICE, SWEETS TO BRING BLOOD GLUCOSE BACK. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM DURING MANUAL PRIME. TROUBLE SHOOTING WAS PERFORMED FOR NO DELIVERY ALARM AND ISSUE WAS RESOLVED BY CHANGING COMPLETE SET. CUSTOMER DID NOT WANT TO TROUBLE SHOOT HYPOGLYCEMIA AS THEY KNOW CAUSE OF HYPOGLYCEMIA. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9114642 ↗
• MalfunctionSep 23, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR LIP RING WAS LOOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE RESERVOIR DID LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105010 ↗
• MalfunctionSep 20, 2019Display 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

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SCREEN WAS DARK AND UNREADABLE, BUTTONS WERE STICKY AND WERE HARDER TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9098513 ↗
• InjuryAug 22, 2019Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HE EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER ALSO REPORTED THAT HE KEPT ON GETTING NO DELIVERY ALARM AND ALSO RECEIVED MOTOR ERROR. THE INSULIN PUMP HAD BEEN EXPOSED TO X RAY MACHINE. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING AND IT WAS REPORTED THAT HE WAS ABLE TO COMPLETE INSULIN PUMP REWIND. 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 8919341 ↗
• InjuryAug 22, 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 REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THEY RECEIVED A NO DELIVERY ALARM. THE CUSTOMER WAS DELIVERING A BOLUS WHEN THEY BEGAN EXPERIENCING THE ISSUES. THE CUSTOMER INFORMED THAT THE INSULIN EXITED. THEY WERE UNABLE TO REMOVE SET AT THIS TIME TO TEST SITE PORTION OF INFUSION SET. THE CUSTOMER WAS ADVISED TO CHANGE OUT THE ENTIRE INFUSION SET SYSTEM. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8919295 ↗
• MalfunctionJul 29, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 168 MG/DL. THE BUTTONS WERE NOT RESPONDING. THE TIME CLOCK WAS NOT ADVANCES. 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: No Consequences Or Impact To Patient

  MAUDE report 8835059 ↗
• MalfunctionJul 1, 2019No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem

  CUSTOMER'S SISTER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD EXPOSED MOISTURE. CUSTOMER STATES THAT THE INSULIN PUMP WAS NOT WORKING AND IT WAS BEEPING. CUSTOMER STATES A CONSTANT TONE WAS OCCURRING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 145 MG/DL. 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: No Consequences Or Impact To Patient

  MAUDE report 8747592 ↗
• MalfunctionJul 1, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY REQUESTED FOR BELT CLIP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8747510 ↗
• MalfunctionJun 11, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE LIP HAD BROKEN OFF RESERVOIR THREADING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8686896 ↗
• MalfunctionJun 10, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. CUSTOMER STATES SQUIRTING DURING MANUAL PRIMING PROCESS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682031 ↗
• MalfunctionJun 6, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DAMAGED AT THE CASE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674047 ↗

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