MiniMed® 530G MMT-751PNAHRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00643169507326), received between Jun 2, 2017 and May 11, 2020 — classified as 17 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (6 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY AND THE DOWN BUTTON WAS NOT WORKING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10042193 ↗
• InjuryJan 29, 2020Power Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND THEY DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO OFF NO POWER ALERT. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 530 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THE BATTERY WAS NOT PREVIOUSLY USED. CUSTOMER REPORTED THE INSULIN PUMP WAS NOT DROPPED. CUSTOMER STATED THE BATTERY CAP WAS NOT LOOSE, CRACKED OR DAMAGED. THIS WAS THE SECOND OCCURRENCE OF OFF NO POWER ALERT NOW WITHOUT A LOW BATTERY WARNING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9641045 ↗
• MalfunctionNov 12, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE BUTTONS WERE NOT RESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 127 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9309289 ↗
• MalfunctionSep 25, 2019Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE BATTERY LIFE HAD DIMINISHED AND REWINDS SLOWER THAN IT HAS IN THE PAST. CUSTOMER DECLINED TO SPEAK TECHNICAL SUPPORT DEPARTMENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9114576 ↗
• InjuryAug 20, 2019Incorrect, Inadequate or Imprecise Result or Readings; Calibration Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT A CALIBRATION ERROR OCCURRED, AND THERE WAS A DIFFERENCE BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE VALUES. THE CUSTOMER ALSO REPORTED EXPERIENCING LOW BLOOD GLUCOSE LEVELS. THE CUSTOMERS BLOOD GLUCOSE WAS 50 MG/DL WHILE THE SENSOR GLUCOSE VALUES WERE 135MG/DL. THE CUSTOMER DID NOT REPORT ANY SYMPTOMS OR TREATMENT METHODS. TROUBLESHOOTING WAS COMPLETED, AND A REPLACEMENT SENSOR WILL BE SENT. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8913200 ↗
• MalfunctionApr 27, 2019Device Alarm System; Device Difficult to Program or Calibrate; Battery Problem; Device Alarm System; Device Difficult to Program or Calibrate; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE HARDER TO RESPOND, LOW BATTERY DID NOT ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ALSO REPORTED THAT INSULIN PUMP BATTERY WAS NOT LASTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8559223 ↗
• MalfunctionApr 22, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Moisture or Humidity Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Moisture or Humidity Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF INSULIN PUMP WAS HARD TO PRESS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD TWO CRACKS AROUND BATTERY OPENING AND SMALL CRACK NEAR RESERVOIR OPENING. THE CUSTOMER ALSO STATED THAT THEY HAD REWIND THE INSULIN PUMP MORE THAN ONCE PER RESERVOIR CHANGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8535074 ↗
• MalfunctionApr 1, 2019Moisture or Humidity Problem; Moisture or Humidity Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD PUMP EXPOSED TO FLUID. CUSTOMER REPORTED PUMP FELL IN THE TOILET. CUSTOMER REPORTED THAT SHE WAS ABLE TO PICK UP THE PUMP AFTER IT FELL IT ONLY TOOK A COUPLE OF SECONDS IN THE WATER INSULIN PUMP DID NOT GO BLANK AND IT DID NOT ALARM OR VIBRATE OR ALERT ANY PUMP ERROR. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8468654 ↗
• MalfunctionFeb 27, 2019Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP REJECTS NEW BATTERIES, MOTOR SLUGGISH DURING REWIND AND ALSO HAD RANDOM NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER ALSO REPORTED RESERVOIR WINDOW WAS CRACK AND BACKLIGHT WAS DIMMER. ESC BUTTON HAS TO BE PUSHED IN SPECIFIC AREA TO WORK. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8373041 ↗
• InjuryDec 12, 2018Device Difficult to Program or Calibrate; No Apparent Adverse Event; Device Difficult to Program or Calibrate; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETO ACIDOSIS ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 1100 MG/DL. THE CUSTOMER'S CURRENT BLOOD GLUCOSE IS 300 MG/DL. THE CUSTOMER WAS TREATED BY MANUAL INJECTION. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. CUSTOMER SATES THAT BUTTON WAS NOT WORKING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8154077 ↗
• MalfunctionOct 19, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP BUTTONS GET STUCK AND ISSUES WITH BOLUSING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER DECLINED TO TRANSFER TO HELPLINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7987094 ↗
• InjurySep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 500 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 155 MG/DL. THE CUSTOMER TREATED WITH THE MANUAL INJECTION. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD A MOTOR ERROR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7896708 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 639 MG/DL AND THEN ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 520 MG/DL. THE CUSTOMER WAS TREATED BY INSULIN AND INTRAVENOUS FLUIDS. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. CUSTOMER WAS OFF THE INSULIN PUMP SINCE (B)(6) 2018. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7783161 ↗
• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 45 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WILL NOT RETURNED DEVICE FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7693767 ↗
• MalfunctionJul 3, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED VIA WEBSITE NO DELIVERY ISSUE. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. IT WAS REPORTED DIMINISHED BATTERY LIFE AND UNEXPLAINED NO DELIVERY ALARMS. NO TROUBLE SHOOTING WAS DONE AS THE CUSTOMER COULD NOT BE REACHED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657509 ↗
• InjuryJun 15, 2018Excess Flow or Over-Infusion

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE AND GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 29 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN INTRAVENOUS FLUIDS TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER BELIEVES THE PUMP IS OVER DELIVERING. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE CUSTOMER REPORTED PUMP PHYSICAL DAMAGE AND THE RESERVOIR CANNOT LOCK IN PLACE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7604822 ↗
• InjuryJun 11, 2018Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE DUE TO THE INFUSION SET DETACHING AT THE QUICK RELEASE. BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 394 MG/DL WHICH WAS TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS DECLINED. THE CUSTOMER THEN REPORTED EXPERIENCING LOW BLOOD GLUCOSE OF 54 MG/DL. THE CUSTOMER TREATED WITH FOOD. TROUBLESHOOTING WAS DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7589951 ↗
• InjuryJun 8, 2018Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL IN THE RANGE OF 575MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 575 MG/DL. CUSTOMER¿S BLOOD GLUCOSE 451 MG/DL AT THE TIME OF CALL. CUSTOMER WAS TREATED WITH INSULIN SHOT. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID NOT ALLEGE FOR UNDER DELIVERING. THE PRODUCT WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7581439 ↗
• MalfunctionJun 2, 2018Detachment Of Device Component; Component Falling; Crack

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 198 MG/DL. THE CUSTOMER REPORTED THAT THERE WAS A CRACK BY BATTERY AND CRACK BY RESERVOIR AND HOLSTER AND CLIP FELLED OFF. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED THE RESERVOIR LOCK IN PLACE THERE HAVE BEEN 1 OR 2 TIMES WHEN NOT ABLE TO LOCK. ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7563762 ↗
• MalfunctionMay 31, 2018Break

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY HAD CRACK AT TOP OF RESERVOIR COMPARTMENT AND THE LIP AROUND THE TOP WAS BROKEN AND O-RING CAME OUT ALSO IT WAS COMING LOOSE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTION. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7557168 ↗
• InjuryFeb 15, 2018Crack

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL WAS IN A RANGE OF 24-32B MG/DL THE CUSTOMER WAS TREATED WITH FOOD AND GLUCOSE TABLETS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT TIME OF INCIDENT. CUSTOMER'S CURRENT BLOOD GLUCOSE VALUE WAS 118 MG/DL. CUSTOMER STATED PUMP HAD A CRACK IN THE BATTERY RESERVOIR. CUSTOMER DECLINED TROUBLESHOOT FOR LOW BLOOD LEVEL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7275311 ↗
• MalfunctionFeb 5, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. CUSTOMER REPORTED A MOTOR POSITION ENCODER ERROR. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7242666 ↗
• InjuryOct 17, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 511 MG/DL AT THE TIME OF THE INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER DID NOT EXPERIENCED ANY SYMPTOMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6955297 ↗
• MalfunctionSep 20, 2017Device Stops Intermittently; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED AN EXTERNAL FLASH CRC ERROR AND COMPLETELY SHUTS DOWN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 115 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6881306 ↗
• MalfunctionSep 12, 2017Crack; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN UNEXPECTED RESTART. CUSTOMER STATED THE DEVICE STARTED BEEPING, COUNTING NUMBERS AND AFTER SETTING THE TIME AND DATE, IT STARTED COUNTING AGAIN. THE ALARM DID NOT OCCUR SHORTLY AFTER INSERTING A NEW BATTERY. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS NOT PROVIDED. CUSTOMER ALSO REPORTED THAT THE HAD A CRACK ON THE SCREEN TOWARDS THE RESERVOIR COMPARTMENT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6860210 ↗

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