MiniMed® 530G MMT-551LNAL (UDI 00643169507715)Recalls & reported problems

Summary

The FDA's MAUDE database contains 708 adverse event reports that list this exact device (DI 00643169507715), received between Jun 1, 2017 and Aug 7, 2020 — classified as 3 deaths, 265 injuries, 440 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (114 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 708 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2020Wireless Communication Problem; Wireless Communication Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD RF PIC FAILED SELFTEST ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND PERFORMED SELF TEST AND IT WAS FAILED. 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 10379899 ↗
• InjuryAug 4, 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 CUSTOMER HAD TO VISIT EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE ON JULY 26, 2020. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 526 MG/DL AND OTHER WAS 431 MG/DL AND 185 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION AND INSULIN PEN AND HOSPITALIZATION TREATMENT WAS INTRAVENOUS INSULIN INFUSION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10360496 ↗
• MalfunctionJul 31, 2020Display or Visual Feedback Problem; Mechanical Problem; Insufficient Flow or Under Infusion; Display or Visual Feedback Problem; Mechanical Problem; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC THE USER ALLEGED THE INSULIN PUMP WAS UNDER DELIVERING INSULIN. CUSTOMER WAS DELIVERING A BOLUS BUT THEIR BLOOD GLUCOSE DID NOT COME DOWN. THE USER EXPERIENCED HIGH BLOOD GLUCOSE WHICH WAS TREATED WITH THE INSULIN PUMP AND SOMETIMES THEY HAD TO CHANGE THE SET TO RESOLVE THE ISSUE. THE CUSTOMER ALSO REPORTED THAT THE REWINDS WERE LOUDER AND SLOWER. THE BACKLIGHT WAS DIMMER. THE DRIVE SUPPORT CAP WAS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10348720 ↗
• MalfunctionJul 29, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARD TO PRESS. THE TIME ON THE INSULIN PUMP ADVANCED. 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 10337295 ↗
• MalfunctionJul 21, 2020Mechanical Problem; Mechanical Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306030 ↗
• MalfunctionJul 20, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS DAMAGED. CUSTOMER REPORTS THEY WERE UNABLE TO DESCRIBE THE POSSIBLE DAMAGE TO THE DRIVE SUPPORT CAP AND SELF TEST WAS PASSED. 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 10294248 ↗
• MalfunctionJul 14, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ACT BUTTON WAS STICKING. CUSTOMER STATED INSULIN DELIVERY SUSPECTED IRREGULARLY AND UNEXPLAINED NO DELIVERY ALERTS. CUSTOMER STATED CONDENSATION INSIDE THE SCREEN. 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 10269590 ↗
• InjuryJun 24, 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. BLOOD GLUCOSE READING WAS 400 MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE HIGH BLOOD GLUCOSE INCIDENT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED HIGH BLOOD GLUCOSE LEVEL WITH INSULIN PUMP AND PEN. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10188545 ↗
• MalfunctionJun 19, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR CHAMBER WAS CRACKED AND HAD CHIPPED PIECE. CUSTOMER REPORTED THAT THERE WAS PHYSICAL DAMAGE TO THE INSULIN PUMP'S RETAINER RING AND THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO 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 10172885 ↗
• MalfunctionJun 19, 2020Battery Problem; Power Problem; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT, THE INSULIN PUMP GOT ERRORS AFTER REPLACING THE BATTERIES. 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 10172314 ↗
• InjuryJun 18, 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 HOSPITALIZED IN EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE LEVEL WAS 11 MG/DL. THE CUSTOMER CURRENT BLOOD GLUCOSE LEVEL WAS 218 MG/DL. THE CUSTOMER WAS TREATED WITH FOOD AND CUPS OF COFFEE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10166088 ↗
• MalfunctionJun 12, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THEY DID NOT RECEIVE 2ND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. 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 10147290 ↗
• InjuryJun 10, 2020Mechanical Problem; Obstruction of Flow; No Apparent Adverse Event; Mechanical Problem; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 429 MG/DL, 200 MG/DL TO 300 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER STATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND NO DELIVERY ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. CUSTOMER DID NOT REPORT MOTOR POSITION ENCODER ERROR. CUSTOMER ALSO STATED THAT INSULIN PUMP WAS NOT WORKING PROPERLY. CUSTOMER STATED THAT EVENT WAS RESOLVED BY CHANGING COMPLETE SET. CUSTOMER WAS PERFORMED SELF AND DISPLACEMENT TEST AND IT WAS PASSED. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10137874 ↗
• MalfunctionMay 29, 2020Premature Discharge of Battery; Loss of Data; Power Problem; Premature Discharge of Battery; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND A COLD RESET WAS PERFORMED. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM AND ALSO WAS ABLE TO REWIND THE PUMP. CUSTOMER ALSO REPORTED THAT ALARMED RECURRED AFTER INSERTING A NEW BATTERY. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10100063 ↗
• MalfunctionMay 27, 2020Device Difficult to Program or Calibrate; Priming Problem; Device Difficult to Program or Calibrate; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN SQUIRTS WHILE PRIMING AND BUTTONS STICKY. 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 10091166 ↗
• MalfunctionMay 23, 2020Failure to Cycle; Mechanical Problem; Detachment of Device or Device Component; Failure to Cycle; Mechanical Problem; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND MULTIPLE MOTOR ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED BEFORE THE MOTOR ERRORS STARTED. THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER STATED THAT SHE HAD NOT APPLIED ANY PRESSURE TO THE DRIVE SUPPORT CAP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10084617 ↗
• MalfunctionMay 23, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT BUTTONS WERE HARD TO PRESS MULTIPLE TIMES AND ALL BUTTONS AND ACT BUTTON WERE NOT RESPONDING. 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 10084542 ↗
• MalfunctionApr 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACKS AND CHIPS ON THE PUMP, MISSING PIECES AROUND THE EDGE OF THE RESERVOIR COMPARTMENT. THE CUSTOMER DECLINED TO PROVIDE THEIR BLOOD GLUCOSE LEVELS. THE CUSTOMER DECLINED BEING TRANSFERRED TO TECHNICAL SUPPORT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10012759 ↗
• DeathApr 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2020. THE CAUSE OF DEATH WAS DUE TO A FATAL CAR ACCIDENT WHERE THE CUSTOMER WAS THE DRIVER. THE CALLER STATED THAT THE CUSTOMER HAD NO OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS USING A COMPETITOR'S SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death

  MAUDE report 10003985 ↗
• MalfunctionApr 22, 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. CUSTOMER STATED DRIVE SUPPORT CAP WAS STICKING OUT. 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 9986706 ↗
• InjuryApr 8, 2020Failure to Cycle; No Apparent Adverse Event; Failure to Cycle; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED THE HIGH BLOOD GLUCOSE OF 500 MG/DL AND INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER REPORTED THAT DRIVE SUPPORT CAP WAS NORMAL. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9936252 ↗
• InjuryApr 7, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE, DIABETIC KETO ACIDOSIS ON (B)(6) 2020 WITH BLOOD GLUCOSE LEVEL WAS 767 MG/DL. CUSTOMER WAS EXPERIENCED SYMPTOMS SUCH AS NAUSEA, VOMITING, ABDOMINAL PAIN, DIFFICULTY BREATHING. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS TREATED WITH INTRAVENOUS DRIP. CUSTOMER ALLEGE INSULIN PUMP WAS UNDER DELIVERING. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Abdominal Pain; Dyspnea; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Vomiting

  MAUDE report 9932128 ↗
• MalfunctionApr 3, 2020Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT BUTTON WAS NOT ALWAYS RESPONSIVE. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE FOR A WEEK AND CRACK IN CASING AT BATTERY COMPARTMENT. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP¿S SCREEN WAS SCRATCHED BUT IT DID NOT IMPAIRED VISIBILITY. CUSTOMER DECLINED TROUBLESHOOTING. 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 9923997 ↗
• MalfunctionApr 2, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR LIP RING WAS CRACKED. THE CUSTOMER STATED THAT THE RESERVOIR 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 9918556 ↗
• MalfunctionMar 16, 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 A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE INSULIN PUMP WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM AND THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 9834705 ↗

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