MiniMed® 530G MMT-551LNAH (UDI 00643169507708)Recalls & reported problems

Summary

The FDA's MAUDE database contains 351 adverse event reports that list this exact device (DI 00643169507708), received between May 30, 2017 and Apr 14, 2023 — classified as 3 deaths, 144 injuries, 204 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (56 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 351 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2023Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED A MOTOR ERROR ALARM. THE CUSTOMER ALSO REPORTED BATTERY FAILED ALARM, REMOVED THE BATTERY AND CONNECTED A NEW BATTERY. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740609 ↗
• MalfunctionNov 9, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RETAINER RING WAS CHIPPED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT RESERVOIR ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10807258 ↗
• MalfunctionAug 11, 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

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTON HARDER TO PRESS, UNRESPONSIVE AND STICK. CUSTOMER REPORTED THAT THE INSULIN PUMP REJECTED NEW BATTERIES AND UNEXPLAINED NO INSULIN DELIVERY ALERT. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD CRACK ON RESERVOIR AND SQUIRTS ON 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 10389332 ↗
• MalfunctionAug 5, 2020Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WAS CRACKED AND HARD TO READ DISPLAY. CUSTOMER STATED INSULIN PUMP HAD MORE NOISE AND SLOWER WHEN REWINDING. 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 10366432 ↗
• InjuryJul 31, 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 AND LOW BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 400 MG/DL AND THEN COULD NOT CORRECT UNTIL SHE WAS OVER 350 MG/DL. CUSTOMER OTHER BLOOD GLUCOSE VALUES WERE 42 MG/DL AND COULD NOT BE AWAKENED NOT GET IT TO GO UP AND SHE COULD NOT GET IT OVER 100 MG/DL AND NOW THIS MORNING WAS 348 MG/DL AND THEN 143 MG/DL. CUSTOMER STATED THAT THERE WAS CRACK AT TWO PLACES BATTERY COMPARTMENT AND RESERVOIR COMPARTMENT. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE AS SHE SAID SHE FEELS IT WAS DUE TO DAMAGE AND JUST NEEDS IT REPLACED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10349863 ↗
• InjuryJul 31, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA AS WELL AS HYPOGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 42 MG/DL TO 400 MG/DL. THE INSULIN PUMP WAS CRACKED AT THE BATTERY COMPARTMENT AND RESERVOIR COMPARTMENT. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH AS WELL AS LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED INF SET.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10348691 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL AS WELL AS LOW BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 400 MG/DL, 42 MG/DL. CUSTOMER STATED INSULIN PUMP HAD CRACK AT BATTERY COMPARTMENT AND RESERVOIR COMPARTMENT. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL AS WELL AS LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10348617 ↗
• MalfunctionJul 20, 2020Moisture or Humidity Problem; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP STOPPED WORKING. CUSTOMER REPORTED THAT INSULIN PUMP WAS EXPOSED TO MOISTURE. 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 10294333 ↗
• MalfunctionJul 1, 2020Premature Discharge of Battery; Use of Device Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Use of Device Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RESET WHEN PLACING NEW BATTERY AND CRACKED ON RESERVOIR COMPARTMENT. 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 10217157 ↗
• MalfunctionJun 4, 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 BUTTON OF INSULIN PUMP WERE HARD TO PRESS AND INSULIN PUMP RECEIVED 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 10117864 ↗
• MalfunctionJun 3, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE UP AND DOWN BUTTONS OF INSULIN PUMP WERE HARDER TO PRESS OR LESS RESPONSIVE. 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 10117328 ↗
• MalfunctionMay 20, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE STICKING AND MAKING IT DIFFICULT TO OPERATE INSULIN PUMP. 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 10074911 ↗
• MalfunctionMay 19, 2020Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND FAILED BATTERY TEST ALARM. 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 10068509 ↗
• MalfunctionMay 19, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER STATED THEY DRIVE SUPPORT CAP WAS 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 10068488 ↗
• MalfunctionMay 11, 2020Display or Visual Feedback Problem; Battery Problem; Adverse Event Without Identified Device or Use Problem; Priming Problem; Display or Visual Feedback Problem; Battery Problem; Adverse Event Without Identified Device or Use Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN WAS SQUIRTING DURING PRIME. CUSTOMER STATED THAT THE DISPLAY LIGHT WAS DIMMER AND HAD TO PLACE IN LIGHT TO READ THE SCREEN. CUSTOMER STATED THAT THE INSULIN PUMP BATTERY WAS OUT OF RANGE AND REJECTS NEW BATTERIES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP NOT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10042285 ↗
• MalfunctionMay 6, 2020Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SOMETIMES SHOOTS OR SQUIRTS INSULIN FROM INFUSION SET DURING PRIMING. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD REJECTED NEW BATTERIES, HAD CRACKS IN INSULIN PUMP CASING NEAR BATTERY THREADING AND HAD UNEXPLAINED OR 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 10027809 ↗
• MalfunctionApr 11, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED A MOTOR ERROR. THE CUSTOMER DID NOT COMPLETE TROUBLESHOOT GUIDE. 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 9951415 ↗
• InjuryApr 8, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND INSULIN PUMP HAD CRACKED RESERVOIR RING. THE BLOOD GLUCOSE OF CUSTOMER WAS 548 MG/DL. CUSTOMER WAS TREATED FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9937396 ↗
• MalfunctionMar 11, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A SCRATCHED DISPLAY SCREEN. CUSTOMER STATED THAT THE RESERVOIR AREA WAS CHIPPING. CUSTOMER STATED THAT HE INSULIN PUMP WAS SLOWER 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 9815623 ↗
• MalfunctionFeb 14, 2020Device Difficult to Program or Calibrate; Use of Device Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP BUTTONS WERE SOMETIMES STICKY OR HARDER TO PRESS. CUSTOMER STATED THAT THE CASING HAS CHIPPED NEAR THE BATTERY CAP AND THE INSULIN PUMP LOST DATE AND TIME SETTINGS. 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 9710713 ↗
• MalfunctionFeb 14, 2020Battery Problem; Patient Device Interaction Problem; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SCRATCHES ON SCREEN THAT MAKE IT HARD TO READ. 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 9710700 ↗
• InjuryFeb 13, 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 EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 48 MG/DL. THE CUSTOMER TREATED FOR LOW BLOOD GLUCOSE VALUE WITH (B)(6). THE CUSTOMER WAS DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9709830 ↗
• MalfunctionFeb 13, 2020Device Alarm System; Mechanical Problem; Device Difficult to Program or Calibrate; Device Alarm System; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD STICKY BUTTONS. CUSTOMER STATED INSULIN PUMP HAD NOT FULLY COMPLETED REWIND AND HAD TO START OVER ALSO THEY DID NOT RECEIVED LOW RESERVOIR ALERT. 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 9705165 ↗
• MalfunctionFeb 11, 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 INSULIN PUMP¿S ACT BUTTON WAS STICKING USUALLY DURING REWIND PROCESS. CUSTOMER STATED THE INSULIN PUMP HAD CRACK ALONG BATTERY COMPARTMENT. 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 9691680 ↗
• MalfunctionJan 30, 2020Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND NO DELIVERY ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER STATED THAT INSULIN PUMP CRACKED ON RESERVOIR COMPARTMENT BY BATTERY COMPARTMENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9650476 ↗

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