MiniMed® 530G MMT-551NAH (UDI 00643169736023)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00643169736023), received between Sep 22, 2017 and Jan 6, 2021 — classified as 14 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2021No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER STATED THEY WERE NOT ABLE TO RESOLVE THE BLANK DISPLAY ISSUE. THE CUSTOMER REPORTED THAT SOMETHING WAS WRONG WITH THEIR PUMP AND THEY HAD BEEN HAVING ERRATIC BLOOD GLUCOSE READINGS FOR 2 TO 3 WEEKS. THE CUSTOMER REPORTED GETTING A HIGH ON THE DAY OF THE CALL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE CUSTOMER REPORTED ISSUES WITH REPLACEMENT PUMP DRAINING BATTERIES FASTER THAN NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125713 ↗
• MalfunctionJul 15, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. THE TROUBLESHOOTING WAS PERFORMED AND CUSTOMER ALSO STATED THAT THEY DID NOT RECEIVED ANOTHER UNEXPECTED RESTART ALARM AFTER BATTERY CHANGE. CUSTOMER STATED THAT UNEXPECTED RESTART ALARM WAS RECURRING DURING NORMAL INSULIN PUMP USE. 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 10275754 ↗
• MalfunctionFeb 23, 2020No Display/Image; Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Insufficient Device Problem Information; No Display/Image; Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED UNSPECIFIED PUMP ERROR ALARM AND RANDOM NO DELIVERY ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER STATED THAT INSULIN PUMP HAD DIMINISHED BATTERY LIFE AND REWIND TAKE LONGER. CUSTOMER STATED THAT INSULIN PUMP ERASED SETTING WHEN PUTTING IN A NEW BATTERY AND HAD BEEN NON RESPONSIVE TO A BRAND NEW BATTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9743157 ↗
• MalfunctionSep 30, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S BUTTONS WERE HARDER TO PRESS AND HARD TO PUSH MORE THAN ONCE TO GET IT RESPONSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP REJECTED NEW BATTERIES. CUSTOMER DECLINE TO TROUBLESHOOTING WITH TECHNICAL SUPPORT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9133209 ↗
• MalfunctionSep 19, 2019Failure of Device to Self-Test; Failure of Device to Self-Test

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY DID HIGH PRESSURE TEST ON THE INSULIN PUMP AND IT WAS FAILED AND DID NOT GET ANY ALARM FOR NO DELIVERY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS HIGH OF 253 MG/DL SINCE SUNDAY NIGHT. CUSTOMER DID NOT CALLED BACK TO PERFORM HIGH PRESSURE TEST. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER FELT OK TO TROUBLESHOOTING HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WISHED TO CONTINUE INSULIN PUMP TROUBLESHOOTING FOR POSSIBLE CAUSES OF HIGH BLOOD GLUCOSE. CUSTOMER WAS EXPLAINED THE TWO HIGH BLOOD GLUCOSE RULE. CUSTOMER WAS ADVISED TO CHANGE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT PER HEALTHCARE PROFESSIONAL'S INSTRUCTIONS. CUSTOMER WAS ADVISED TO CALL BACK FOR ASSISTANCE IF HIGH BLOOD GLUCOSE PERSIST. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9096177 ↗
• MalfunctionSep 16, 2019Mechanical Problem; Moisture or Humidity Problem; Mechanical Problem; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 111 MG/DL. CUSTOMER STATED THAT SHE WENT INTO POOL WITH WEARING HER INSULIN PUMP. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE INSULIN PUMP REWIND. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO DISCONTINUE USE OF THE INSULIN PUMP AND REFER TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9070427 ↗
• MalfunctionAug 27, 2019Device Alarm System; Mechanical Problem; Insufficient Flow or Under Infusion; Obstruction of Flow; Power Problem; Priming Problem; Device Alarm System; Mechanical Problem; Insufficient Flow or Under Infusion; Obstruction of Flow; Power Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS PRIME AND REWIND MORE THAN ONCE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THERE WAS NO LOW BATTERY WARNING. THE CUSTOMER STATED THAT INSULIN PUMP DID NOT HELP TO DECREASE BLOOD GLUCOSE EVEN WHEN INSULIN WAS GIVEN. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935601 ↗
• MalfunctionJul 23, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S BUTTONS WERE NOT FUNCTIONING. BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS 157 MG/DL. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8814719 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED THE HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS ABOVE 400, 413 MG/DL. THE CUSTOMER WAS TREATED WITH THE INSULIN PUMP. THE CUSTOMER DECLINED THE HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE CUSTOMER STATED THAT THE INFUSION SET WAS LEAK. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8756825 ↗
• InjuryJul 2, 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 HAD EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 34 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS IN THE AMBULANCE. THE CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8751944 ↗
• MalfunctionJun 28, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS REWINDING SLOWER, BUTTON HAD TO BE PRESSED TWICE, INSULIN WAS SHOOTING OUT DURING PRIMING, HAD SCUFFS ON THE SCREEN AND WAS MAKING GRINDING NOISE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8743111 ↗
• InjuryMay 13, 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 EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS IN THE RANGE OF 481 MG/DL TO 500 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH GLUCOSE. CUSTOMER STATED THAT THE CANNULA WAS BENT. THE INSULIN PUMP WILL NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8603079 ↗
• MalfunctionFeb 20, 2019Patient 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 8352770 ↗
• MalfunctionFeb 19, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE UP BUTTON WAS HARDER TO HOLD AND PRESS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8352737 ↗
• MalfunctionDec 5, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD COSMETIC DAMAGE AND CRACK. 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 8136442 ↗
• MalfunctionNov 20, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PIECE OF RESERVOIR COMPARTMENT WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 126 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVISED THE INSULIN PUMP HAS TO BE REPLACED AND REVERT TO BACK-UP PLAN PER HEALTH CARE PROVIDER'S INSTRUCTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8089086 ↗
• MalfunctionNov 8, 2018Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALARM. THE BLOOD GLUCOSE LEVEL WAS 370 MG/DL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOT. CUSTOMER STATE THAT THEY HAD TRIED ALL REMEDIES. THE PRODUCT WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8049748 ↗
• InjuryNov 6, 2018Adverse 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 THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH INSULIN PUMP AND MANUAL INJECTION FOR HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8044979 ↗
• MalfunctionOct 23, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP UP AND DOWN ARROW WAS A LITTLE STICKY, REWINDING WAS SLOWER, HAD RECEIVED NO DELIVERY ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997603 ↗
• MalfunctionOct 5, 2018No Display/Image; No Display/Image

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BLANK DISPLAY. THE BLOOD GLUCOSE LEVEL WAS AT 174 MG/DL THE TIME OF INCIDENT. CUSTOMER STATED THAT THE CRACK TO THE RESERVOIR COMPARTMENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7938043 ↗
• InjuryOct 4, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 470 MG/DL. THE CUSTOMER ALSO REPORTED NO DELIVERY ALARM. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN EXITED DURING MANUAL PRIME. THE INSULIN PUMP WILL BOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR. UNOMED SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7937083 ↗
• InjuryAug 28, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE. THE PRODUCT WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7821591 ↗
• MalfunctionJul 4, 2018No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 300 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND CUSTOMER REPORTS DISPLAY WAS BLANK CURRENTLY. CUSTOMER STATES THE DISPLAY DID NOT RETURNED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WILL BE REPLACED AS PER TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7661903 ↗
• MalfunctionJun 25, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AS WELL AS LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER'S HIGH BLOOD GLUCOSE LEVEL WAS 400 MG/DL THE CUSTOMER'S LOW BLOOD GLUCOSE LEVEL WAS 36 MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE AND LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7632880 ↗
• InjuryMay 25, 2018Crack

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER WAS TREATED BY DELIVERING A BOLUS OFFERED. THE CUSTOMER ALSO STATED THAT BATTERY COMPARTMENT WAS CRACKED AND SHE CHANGED THE BATTERY TWICE IN A WEEK. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE AND CRACKED BATTERY COMPARTMENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7544278 ↗

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