MiniMed® 530G MMT-551LNAP (UDI 00643169507722)Recalls & reported problems

Summary

The FDA's MAUDE database contains 499 adverse event reports that list this exact device (DI 00643169507722), received between May 11, 2017 and Sep 15, 2020 — classified as 218 injuries, 281 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (73 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 499 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2020Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SLOWER TO REWOUND AND CRACK ON TOP OF SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. UPDATED SUMMARY: INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM IN THE LAST 3 WEEKS BUT THERE WAS NO ISSUE WITH REWIND PROCESS. CUSTOMER WAS ALSO GETTING NO DELIVERY ALARM. CUSTOMER STATED THERE WAS A SCRATCH AND CRACK ON THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10538282 ↗
• MalfunctionAug 14, 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 HAD BUTTONS NOT RESPONDING AND HAD A CRACK AND BUTTONS HAVE BEEN STICKING. 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 10405963 ↗
• MalfunctionAug 12, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON THE INSULIN PUMP WERE VERY HARD TO PRESS. 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 10395132 ↗
• MalfunctionAug 6, 2020Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE STICKING. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT THE MOTOR HAD SLUGGISH AND LOUDER DURING REWIND. CUSTOMER STATED THAT THE INSULIN SHOOTS OUT 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 10372860 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED BY THE CUSTOMER VIA PHONE CALL THAT SHE WAS TREATED BY EMERGENCY MEDICAL SERVICE FOR A LOW BLOOD GLUCOSE LEVEL AND UNRESPONSIVENESS ON (B)(6)2020. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 23 MG/DL. SHE WAS TREATED WITH GLUCAGON. CUSTOMER STATED SHE USES A DIFFERENT BASAL PATTERN OVERNIGHT AND FORGOT TO CHANGE IT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10342504 ↗
• MalfunctionJul 21, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS CRACKED AND RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO 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 10300980 ↗
• InjuryJul 6, 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 HAD HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10231418 ↗
• MalfunctionJul 6, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THE 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 10231308 ↗
• MalfunctionJul 2, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM WHEN PRIMING THE INSULIN PUMP. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NOT 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 10223183 ↗
• MalfunctionJun 23, 2020No Display/Image; Battery Problem; Patient Device Interaction Problem; No Display/Image; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT DISPLAY OF INSULIN PUMP WAS BLANK. CUSTOMER STATED THAT INSULIN PUMP SHOW LOW BATTERY SO CUSTOMER TRIED CHANGING BATTERY BUT THEY ALREADY TRIED MULTIPLE TIMES AND INSULIN PUMP WAS NOT TURNING ON AT ALL. CUSTOMER ALSO STATED THAT BATTERY CAP WAS LOOKS FINE. CUSTOMER STATED THAT THERE WAS 3 CRACKS ON THE CORNER OF THE RESERVOIR COMPARTMENT. THE CUSTOMER ALSO REPORTED THAT 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 10184414 ↗
• MalfunctionJun 19, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PIECE OF PLASTIC FROM RESERVOIR WAS MISSING. THERE WAS CHIPPING AROUND BATTERY AREA AND THE BATTERY TERMINALS DID NOT ALWAYS WORK. 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 10172815 ↗
• InjuryMay 22, 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 IN THE EMERGENCY ROOM ON (B)(6) 2020 DUE TO LOW BLOOD GLUCOSE LEVEL WITH A BLOOD GLUCOSE LEVELS OF 37 MG/DL AND 47 MG/DL. THE CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE FOR TWO WEEKS AND TREATED WITH GLUCOSE TABLETS. THE CUSTOMER ALSO REPORTED STOMACH RELATED ISSUES. THE CUSTOMER WAS TREATED WITH CARBOHYDRATES, CRACKERS AND APPLE JUICES AT THE EMERGENCY ROOM. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP APPEARED NORMAL AND THE CUSTOMER DID NOT BELIEVE THAT THE INSULIN PUMP WAS OVER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10081475 ↗
• InjuryMay 19, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 408 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE LEVEL EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10068660 ↗
• InjuryMay 12, 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 HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL WHICH WAS TREATED WITH INSULIN SHOT. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NOT COMFORTABLE WITH THE INSULIN PUMP ANYMORE. CUSTOMER WAS DECLINED TO CONTINUE INSULIN PUMP TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Discomfort; Hyperglycemia

  MAUDE report 10045991 ↗
• MalfunctionApr 29, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALARM. CUSTOMER HAD CHANGED SET AND RESERVOIR MULTIPLE TIMES BUT STILL RECEIVING NO DELIVERY ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10009208 ↗
• MalfunctionApr 16, 2020Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PARTIAL DISPLAY AND NO DELIVERY ALARM. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE PARTIAL DISPLAY AND NO DELIVERY ALARM. THE CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWOUND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968312 ↗
• MalfunctionApr 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT AND HAD EXPERIENCED HIGH BLOOD GLUCOSE AND TREATED WITH MANUAL BOLUS. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9946866 ↗
• MalfunctionApr 6, 2020Computer Software Problem; Failure to Cycle; Computer Software Problem; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THE DRIVE SUPPORT CAP WAS FLUSHED. 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 9927539 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 41 MG/DL. THE CUSTOMER WAS TREATED WITH GLUCOSE TABLETS. THE CUSTOMER REPORTED THAT THE INFUSION SET COMES OFF FROM THE NEEDLE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9871018 ↗
• MalfunctionMar 23, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM BUT NOT ABLE TO COMPLETE THE REWIND PROCESS. 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 9864252 ↗
• MalfunctionMar 19, 2020Device Alarm System; Premature Discharge of Battery; Battery Problem; Power Problem; Device Alarm System; Premature Discharge of Battery; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM, NOT GIVING LOW BATTERY ALERT. THE CUSTOMER ALSO STATED THAT THE BATTERIES GOING THROUGH MORE QUICKLY, INSULIN PUMP SHUT OFF WHEN BATTERY WAS DEAD. 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 9852566 ↗
• MalfunctionMar 4, 2020Premature Discharge of Battery; Power Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCREEN OF INSULIN PUMP WAS CRACKED AND IT HARDER 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 9783949 ↗
• MalfunctionMar 3, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE REWIND. 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 9778543 ↗
• MalfunctionMar 2, 2020Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCRATCHES ON THE RESERVOIR CASING. INSULIN PUMP HAD 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 9773341 ↗
• MalfunctionFeb 12, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BUTTON ERROR. THE CUSTOMER STATED THAT THE ERROR USUALLY CAME UP WHEN SHE PRESSED THAT DOWN BUTTONS MULTIPLE TIMES. THE TIME ON THE INSULIN PUMP WAS ADVANCING. 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 9698962 ↗

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