MiniMed® 530G MMT-751NAB (UDI 00643169736061)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00643169736061), received between Aug 8, 2017 and Dec 11, 2020 — classified as 19 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Feb 13, 2026Class IIOpen, Classified

   All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

   Z-1751-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM EVERY FEW MINUTES. CUSTOMER STATED THAT THE INSULIN WAS LEAKED INSIDE THE INSULIN PUMP. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE INSULIN PUMP 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 10990528 ↗
• MalfunctionApr 9, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT WORKING. THE CUSTOMER STATED THAT THERE WERE CRACKED AROUND THE BATTERY COMPARTMENT. CUSTOMER STATED THE INSULIN PUMP HAD COSMETIC DAMAGE. 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 9943052 ↗
• MalfunctionApr 8, 2020Mechanical Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL FAILED BATTERY TEST AND REWIND ANOMALY ON THE INSULIN PUMP. TROUBLESHOOTING WAS NOT PERFORMED. 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 9934085 ↗
• MalfunctionMar 18, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND ACT BUTTON HAD TO BE PUSHED MULTIPLE TIMES TO WORK. CUSTOMER STATED THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM AND CUSTOMER WAS GETTING HIGHS AFTER RUNNING AND WHEN SLEEPING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9847045 ↗
• MalfunctionJan 28, 2020Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE, WATERMARK ON SCREEN AND NO DELIVERY ALARMS OCCASIONAL. 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 9635862 ↗
• InjuryJan 17, 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 PATIENT HOSPICE CARE. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2019. THE CAUSE OF DEATH WAS CANCER. THE CALLER STATED THAT THE CUSTOMER HAD CANCER THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 500 MG/DL AT THE TIME OF ADMISSION. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death; Hyperglycemia

  MAUDE report 9600195 ↗
• MalfunctionJan 16, 2020Device Alarm System; Mechanical Problem; Obstruction of Flow; Device Alarm System; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVER ALARM, GRINDS TO REWIND AND LOW RESERVOIR ALARM DOES NOT WORK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595208 ↗
• MalfunctionJan 15, 2020Device Difficult to Program or Calibrate; No Apparent Adverse Event; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS HAD TO BE TO BE DOUBLE PUSHED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE SCREEN WAS PRETTY SCRATCHED UP AND HAD RAINBOW EFFECT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9590030 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 60 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED FOOD AND GLUCOSE TABLETS TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER NEEDED ASSISTANCE CHANGING THEIR PUMP SETTINGS. TROUBLESHOOTING WAS COMPLETED AND NO ISSUES WERE FOUND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9567337 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 405 MG/DL AND 379 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH INSULIN PUMP DELIVERY ONLY. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER DID NOT MENTION ANY SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NOT ALLEGING INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER REPORTED THAT THEY HAVE CONTACTED THEIR HEALTHCARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT THEY WERE NOT ADMITTED TO EMERGENCY ROOM, NOR HOSPITAL OR NOR TO EMERGENCY MEDICAL SERVICE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9449355 ↗
• MalfunctionNov 22, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE THAT THE BUTTONS WERE HARD TO PUSH. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9361712 ↗
• MalfunctionSep 24, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR CAP WAS BROKEN AND THEY HAD TO WATCHED THE RESERVOIR. CUSTOMER BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9109290 ↗
• MalfunctionSep 18, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS POLARIZED EFFECT ON SCREEN MAKES IT HARD TO VIEW. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE BUTTONS WAS LESS RESPONSIVE, HARDER TO PRESS AND SOMETIMES NEED TO PRESS BUTTONS TWICE. IT WAS ALSO STATED THAT THE INSULIN PUMP WAS REJECTING NEW BATTERIES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081485 ↗
• MalfunctionAug 13, 2019No Display/Image; Obstruction of Flow; No Display/Image; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP¿S SCREEN WENT BLANK AND WAS NOT DELIVERING INSULIN CORRECTLY. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8886993 ↗
• InjuryJul 4, 2019Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED THE HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 430 MG/DL. THERE WAS BATTERY OUT LIMIT ALARM. THE CUSTOMER WAS ADVISED TO PERFORMED THE TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE AND BATTERY OUT LIMIT ALARM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8761763 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Power Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; Power Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 430 MG/DL AT THE TIME OF INCIDENT. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE EVENT. CUSTOMER DID NOT MENTION ANY TREATMENTS AND SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8756979 ↗
• MalfunctionJun 18, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE STICKY, INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 130 MG/DL AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8706495 ↗
• MalfunctionJun 6, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. 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 8673690 ↗
• MalfunctionMay 27, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE HARDER TO PRESS AND RECEIVED ERRORS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8643397 ↗
• MalfunctionMay 6, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS OF THE INSULIN PUMP ARE HARD TO PRESS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS MORE THAN 300 MG/DL AND 280 MG/DL AT TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING OUT OF THE PUMP WHENEVER SHE FILLS THE CANNULA. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED AND TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8581774 ↗
• MalfunctionMar 26, 2019Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Priming Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8451471 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO THE HIGH BLOOD GLUCOSE LEVEL AND DIABETIC KETOACIDOSIS ON (B)(6) 2019. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF THE HOSPITALIZATION WAS 380 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS DRIP AND MANUAL INJECTIONS. THE CUSTOMER HAD CHEST PAIN, RAPID HEART RATE AND WAS THROWING UP AND BLOOD PRESSURE WAS LOW. CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8377196 ↗
• InjuryFeb 14, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; No Apparent Adverse Event; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED LOW BLOOD GLUCOSE AND INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 26 MG/DL. THE CUSTOMER REPORTED THAT THE RUNNING THROUGH MORE BATTERIES THAN WHEN NEW BATTERY OUT AND BUTTONS NO LONGER LABELED CLEARLY. IT WAS REPORTED THAT THE REWIND WAS MORE THAN ONCE PER PRIME AND REWINDS SLOWER THAN WHEN NEW AND ALSO HAD UNEXPLAINED NO DELIVERY ALARMS. THE CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8338749 ↗
• MalfunctionFeb 12, 2019Excess Flow or Over-Infusion; Device Difficult to Program or Calibrate; Power Problem; Excess Flow or Over-Infusion; Device Difficult to Program or Calibrate; Power Problem

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP WAS HAVING BATTERY LONGEVITY ISSUES AND STICKING BUTTONS THAT CAUSED THE PUMP TO OVER DELIVER 20 UNITS INTO THE CUSTOMER. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER HAS TO REMOVE THE BATTERY FROM THE PUMP AND LET THE PUMP SIT OR A WHILE TO GET IT WORKING.TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330667 ↗
• InjuryFeb 12, 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 WERE WENT TO EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE AND ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 30 MG/DL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 36 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S CURRENT BLOOD GLUCOSE IS 164 MG/DL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE CUSTOMER WAS UNCONSCIOUS AS A RESULT OF LOW BLOOD GLUCOSE VALUE. THE CUSTOMER TREATED LOW BLOOD GLUCOSE VALUE WITH GLUCAGON. BASED ON CUSTOMER¿S REPORT CUSTOMER DOES NOT ALLEGE OVER DELIVERY BECAUSE OF LOW BLOOD GLUCOSE. THE CUSTOMER WAS NOT RECALL INSULIN DRIPPING OR SQUIRTING FROM END OF SET BEFORE CONNECTING AT THEIR SITE. THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS ABLE TO UPLOAD TO CARELINK. CUSTOMER WAS UNABLE TO COMPLETE CARELINK UPLOAD. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 8330490 ↗

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-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