MiniMed® 530G MMT-551NAP (UDI 00643169736047)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169736047), received between Aug 10, 2017 and Jul 13, 2020 — classified as 7 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2020Power Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A POWER LOSS ALARM. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPLACED THE BATTERY HOWEVER THE ISSUE REMAINED UNRESOLVED. 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 10262870 ↗
• MalfunctionMar 12, 2020Unexpected Therapeutic Results; Unexpected Therapeutic Results

  INFORMATION RECEIVED BY MEDTRONIC THE INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR GLUCOSE VALUE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 120 MG/DL AND SENSOR GLUCOSE WAS 92 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS NOT OUTSIDE THE ACCEPTABLE RANGE. 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 9822076 ↗
• MalfunctionJan 7, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND STUCK BUTTONS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD RANDOM AND UNEXPLAINED DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9556892 ↗
• InjuryApr 18, 2019Moisture or Humidity Problem; No Apparent Adverse Event; Moisture or Humidity Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE WAS OVER 600 MG/DL. THE CUSTOMER STATES THAT PUMP LEAKING INSULIN. THE CUSTOMER STATES THAT LOCATION OF THE LEAKING IS RESERVOIR O RING. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS SUCH AS A RESULT OF HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8525991 ↗
• MalfunctionApr 17, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD BUTTONS ARE VERY HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200 MG/DL 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 DEVICE WILL NOT RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8521752 ↗
• MalfunctionApr 11, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS DID STICK OCCASIONALLY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THE INSULIN PUMP HAD REJECTED NEW BATTERY, CRACK WHERE RESERVOIR GOES IN, INSULIN HAD SQUIRT OUT DURING PRIMING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8502753 ↗
• MalfunctionMar 22, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP SCREEN AND RESERVOIR COMPARTMENT WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAS DAMAGED. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED THE RESERVOIR SECURELY LOCK IN PLACE. 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 8442969 ↗
• MalfunctionMar 14, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTON STICKS DOWN AND CAUSING CARBS TO INCREASE WHEN IT SHOULD NOT. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 194 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS BATTERY DID NOT WORK THE FIRST TIME, HAD TO TAKE OUT AND REPLACE AND BLOW INTO BATTERY AREA AND THERE WAS A SCRATCH ON THE UPPER RIGHT CORNER OF THE SCREEN. CUSTOMER ALSO STATES WHEN THEY PUT IN 46 GRAMS OF CARBS AND THEN SOME REASON THE INSULIN PUMP UPS THE CARBS ON IT OWN AND THE INSULIN PUMP OVERSHOOT THE CARB INTAKE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8419307 ↗
• MalfunctionMar 11, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER'S WEIGHT HAS BEEN CHANGED TO (B)(6).

  Patient problems: Hyperglycemia

  MAUDE report 8407142 ↗
• MalfunctionJan 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA CALL THAT THE PART WHERE THE RESERVOIR GOES IN THERE WAS A CRACK AND THE BLACK RUBBER CIRCLE THAT WAS IN THE RESERVOIR COMPARTMENT IT WAS NOT IN THE PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATE THAT PIECE WAS MISSING. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288256 ↗
• MalfunctionDec 5, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD COSMETIC DAMAGE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8136429 ↗
• MalfunctionOct 19, 2018Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RECEIVED REWIND TAKE LONGER THAN BEFORE AND REJECTED NEW BATTERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT DIMINISHED BLACK LIGHT AND PIECE OF PLASTIC CHIPPING OFF. CUSTOMER TROUBLESHOOT WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985036 ↗
• MalfunctionAug 13, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAS A CRACK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180 MG/DL. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED THE RESERVOIR WAS UNABLE TO LOCK IN PLACE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7778617 ↗
• MalfunctionMay 22, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 200 MG/DL AT THE TIME OF THE INCIDENT. BUTTON NOT WORKING AND ACT WORKS SOMETIMES. 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 7532377 ↗
• MalfunctionMay 10, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BATTERY OUT LIMIT ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 169 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502130 ↗
• MalfunctionMar 15, 2018Failure to Read Input Signal; Noise, Audible

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 290 MG/DL AT THE TIME OF INCIDENT AND DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP WAS MAKING A HIGH PITCHED NOISE AND THE BUTTONS WERE UNRESPONSIVE. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7344051 ↗
• InjuryFeb 2, 2018Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT VIBRATING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 270MG/DL. THE LAST COUPLE OF DAYS WHERE ITS BEEN 300MG/DL, 250MG/DL ,275MG/DL. CUSTOMER TREATED WITH THE PUMP. CUSTOMER ALSO BELIEVED THAT HIS PUMP IS NOT DELIVERING BASALS. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7238671 ↗
• InjuryJan 16, 2018Inaccurate Delivery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS DELIVERING BOLUS SLOWER THAN EXPECTED . THE CUSTOMER'S BLOOD GLUCOSE WAS 164 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7195225 ↗
• MalfunctionDec 29, 2017Break; Detachment Of Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A DAMAGE ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THEY HAD DAMAGE TO RESERVOIR COMPARTMENT AND CUSTOMER ALSO STATED THAT THE BLACK O-RING WAS BROKEN OFF. THE CUSTOMER STATED THAT THE RESERVOIR WAS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN PER HEALTH CARE PROFESSIONAL¿S RECOMMENDATION. THE CUSTOMER WAS ADVISED THAT THE PUMP NEEDS TO BE REPLACED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7155747 ↗
• InjuryNov 28, 2017Air Leak; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS UNDER DELIVERING INSULIN AND THE BLOOD GLUCOSE WAS HIGH AS 600 MG/DL. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE VALUE WAS 300 MG/DL. THE CUSTOMER TREATED WITH A PUMP. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE CUSTOMER STATES HAD AN AIR BUBBLE OF 2 INCHES FROM THE RESERVOIR. ASSISTED CUSTOMER WITH REMOVING BUBBLES FROM TUBING. THE CUSTOMER COULD NOT COMPLETE THE TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7064469 ↗
• InjuryNov 14, 2017Low Test Results

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PATIENT¿S BLOOD GLUCOSE WAS LOW. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 54MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THEY TREATED THE LOW BLOOD GLUCOSE WITH A FOOD, TROUBLE SHOOTING WAS OFFERED DURING CALL AND THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7030165 ↗
• InjurySep 19, 2017Failure to Deliver

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 405 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO STATED THAT THEY GOT NO DELIVERY ALARM. ASSISTED CUSTOMER IN PERFORMING A 5.0 UNIT FIXED PRIME. CUSTOMER STATED THE INSULIN EXITED. PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6876334 ↗
• InjuryAug 10, 2017Device Operates Differently Than Expected; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 440 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE READING. CUSTOMER ALSO REPORTED POWER ISSUE AND FAILED BATTERY TEST. INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6786867 ↗

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