MiniMed® 530G MMT-751LNAH (UDI 00643169933194)Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00643169933194), received between Jan 4, 2018 and Aug 11, 2020 — classified as 32 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (19 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. CUSTOMER WAS UNABLE TO CLEAR ALARM. 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 10389285 ↗
• MalfunctionAug 5, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Power Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Power Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTON WERE HARDER TO PRESS. THE CUSTOMER STATED THAT THE INSULIN PUMP REWIND MORE THAN ONCE, NO DELIVERY ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER STATED THAT THE INSULIN PUMP REJECT NEW BATTERY. 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 10366227 ↗
• InjuryApr 22, 2020Adverse 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 HAD EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE LEVEL OF OVER 400 MG/DL AND THE OTHER BLOOD GLUCOSE LEVEL WERE 200 MG/DL, 250 MG/DL AND 360 MG/DL AT THE TIME OF INCIDENT. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER REPORTED THAT THEY HAD CONTACTED THEIR HEALTH CARE PROFESSIONAL. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE LEVEL. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATED THAT THE DRIVES SUPPORT CAP WAS NORMAL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9985843 ↗
• MalfunctionApr 14, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED A MOTOR ERROR. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. 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 9956438 ↗
• InjuryMar 20, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 569 MG/DL. THE CUSTOMER WAS TREAT WITH MANUAL INJECTION AND BOLUS. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD KEYPAD ISSUE AND THEY HAD TO PRESS THE BUTTONS. CUSTOMER ALSO STATED THAT INSULIN PUMP RECEIVED NO DELIVERY ALARMS. CUSTOMER DECLINED TO TROUBLESHOOT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9858950 ↗
• MalfunctionFeb 18, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK AROUND RESERVOIR AND O-RING WAS MISSING FROM RESERVOIR COMPARTMENT. THE CUSTOMER STATED THAT THE RESERVOIR DID 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 9718924 ↗
• MalfunctionJan 8, 2020Premature Discharge of Battery; Mechanical Problem; Use of Device Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Mechanical Problem; Use of Device Problem; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS SHUT DOWN AND HAD TO RESET SETTINGS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN PUMP HAD MINOR SCRATCHES ON SCREEN, BACKLIGHT WAS STILL BRIGHT AND EXTREMELY DIMINISHED BATTERY LIFE THAT WAS ABOUT 10 TO 15 DAYS. CUSTOMER STATED THAT THE INSULIN PUMP HAD REJECTED NEW BATTERY, IT WAS SLOWER DURING REWIND AND RECEIVED RANDOM NO DELIVERY ALERTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9563339 ↗
• MalfunctionDec 16, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 70 MG/DL. CUSTOMER STATED THAT BATTERY IN INSULIN PUMP BECAUSE IT WAS RECEIVED LOW BATTERY AND THEN SHE WAS NOT ABLE TO GET INSULIN PUMP BACK UP AS WELL AS CUSTOMER WAS TRIED FIVE BATTERIES PRIOR TO CALLING. CUSTOMER STATED THAT THE CONTACT ON THE BATTERY CAP WAS NEITHER MISSING NOR DAMAGED. CUSTOMER STATED THAT BATTERY COMPARTMENT AND SPRING WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THAT DISPLAY DID NOT RETURN. TROUBLESHOOTING WAS PERFORMED FOR BLANK DISPLAY. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED, TO DISCONTINUE USE OF THE INSULIN 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 9473637 ↗
• MalfunctionDec 10, 2019Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SQUIRTED INSULIN DURING THE MANUAL PRIME PROCESS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE DRIVE SUPPORT CAP WAS FLUSHED AND HAD CRACK ON THE INSULIN PUMP. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9443093 ↗
• MalfunctionNov 25, 2019Mechanical Problem; Obstruction of Flow; Power Problem; Insufficient Device Problem Information; Priming Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Insufficient Device Problem Information; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND UNSPECIFIED INSULIN PUMP ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT INSULIN PUMP WAS SLOWER AND LOUDER DURING REWIND AND MOTOR SOUNDS LABORED, MOTOR MAKES GRINDING NOISE AND UNEXPLAINED NO DELIVERY ALERTS NOT DUE TO SITE ISSUES, INSULIN PUMP HAD REJECTED NEW BATTERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9373844 ↗
• InjuryNov 20, 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 LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 50 MG/DL AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9347866 ↗
• MalfunctionOct 29, 2019Computer Software Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Computer Software Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD ERROR CODES AND THE BUTTON WAS DIFFICULT TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THE BUTTON HAD TO BE PRESSED MULTIPLE TIMES AND THERE WAS CRACK ON SCREEN. CUSTOMER DECLINED TO REPORT TO MEDTRONIC 24 HOUR TECHNICAL SUPPORT DEPARTMENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249274 ↗
• MalfunctionOct 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE KEYS ON HER INSULIN PUMP ARE HARD TO PUSH AND WOULDN'T PUMP INSULIN. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. LEADING UP TO THE EVENT, THE CUSTOMER DIDN'T NOTICE ANY KEYPAD ISSUES. THE CUSTOMER COMPLETED TROUBLESHOOTING AND THE BUTTONS WERE STILL HARD TO PRESS, HAD TO PRESS THEM SEVERAL TIMES, AND THE INSULIN PUMP WOULDN'T PUMP INSULIN. THE CUSTOMER CONFIRMED THAT THE TIME ON THE SCREEN ADVANCED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP AND REVERT TO A BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9212368 ↗
• MalfunctionOct 9, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ACT BUTTONS SOMETIMES DID NOT RESPOND. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT BATTERY LIFE LAST FOR 2 WEEKS AND HAD RANDOM NO DELIVERY ALERTS. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9170611 ↗
• MalfunctionOct 3, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD SCROLL BUTTON WAS NOT WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 226 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP WAS STILL WORKING AND WAS ABLE TO DELIVER INSULIN PROPERLY SINCE THEY'RE NOT GETTING ANY DELIVERY ALARM ALERTS. CUSTOMER WAS PERFORMED SELF TEST AND IT WAS COMPLETE WITHOUT ANY ERROR MESSAGE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9149750 ↗
• MalfunctionSep 19, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9085750 ↗
• MalfunctionSep 10, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD HAZINESS AND CLOUDINESS ON SCREEN, GLARE ON SCREEN MAKES IT DIFFICULT TO READ, HARD TO PRESS BUTTONS OR UNRESPONSIVE, MULTIPLE MOTOR ERRORS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED DIMINISHED BATTERY LIFE AND RANDOM NO DELIVERY ALARMS. CUSTOMER DECLINED HELPLINE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8980303 ↗
• InjurySep 10, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF OVER 700 MG/DL AT THE TIME OF HOSPITALIZATION. CUSTOMER ALSO STATED THEY WAS IN EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH INTRAVENOUS FLUID AND MANUAL INJECTION IN THE HOSPITAL. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALERTS EVEN AFTER CHANGING TUBING. CUSTOMER STATED THE INSULIN DID EXIT. CUSTOMER STATED THE INSULIN PUMP DID NOT ALARM NO DELIVERY. CUSTOMER ALSO STATED INSULIN PUMP WORKING DESIGNED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8979390 ↗
• InjuryAug 28, 2019Obstruction of Flow; Power Problem; No Apparent Adverse Event; Obstruction of Flow; Power Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO UNKNOWN REASON AND INSULIN PUMP HAD NO DELIVERY ALARM WITH BLOOD GLUCOSE OF UNKNOWN ALSO STATED THEY EXPERIENCED LOW BLOOD GLUCOSE OF 57 MG/DL. CUSTOMER STATED INSULIN PUMP HAD FAILED BATTERY TEST, BAD BATTERIES ALERT AND NO DELIVERY ALERT. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Complaint, Ill-Defined; Hypoglycemia

  MAUDE report 8938845 ↗
• MalfunctionAug 5, 2019Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Intermittent Communication Failure; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Intermittent Communication Failure

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MULTIPLE PUMP ERROR ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD VIRTUAL WATCH DOG ALARM, MOTION SENSOR TEST FAILURE AND MOTOR ERROR ALARM. CUSTOMER DECLINED FOR TROUBLESHOOTING. CUSTOMER WAS ABLE TO CLEAR THE ALARMS, HOWEVER UNABLE TO COMPLETE INSULIN PUMP REWIND. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND WAS RECOMMENDED TO REFER BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8860752 ↗
• InjuryAug 5, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 400 MG/DL AND INSULIN PUMP RECEIVED NO DELIVERY ALARM ALMOST THE ENTIRE DAY. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY FROM PAST SEVEN DAYS. CUSTOMER DECLINED TO PROCEED WITH TROUBLESHOOTING AND STATED THAT SHE WILL JUST PROCEED IN CHANGING THE ENTIRE SET AND WILL CALL BACK IF ISSUE PERSISTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8858598 ↗
• MalfunctionJul 26, 2019Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ESC BUTTONS WERE BEING UNRESPONSIVE AND INSULIN PUMP HAD REJECTED NEW BATTERIES AND ALSO STATED THAT BATTERY LIFE HAD DEFINITELY DIMINISHED. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8830255 ↗
• MalfunctionJul 22, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Mechanical Problem; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE THAT INSULIN PUMP HAD PRIME AND REWIND PROCESS MULTIPLE TIMES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS AND BATTERY LIFE DIMINISHED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8810602 ↗
• MalfunctionJun 27, 2019Premature Discharge of Battery; Connection Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A UNEXPECTED RESTART ALARM AND RESERVOIR WAS NOT STAY IN INSULIN PUMP DUE TO O RING WAS MISSING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 253 MG/DL AT THE TIME OF THE INCIDENT. THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. THE CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. 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 8742794 ↗
• MalfunctionJun 27, 2019No Display/Image; No Display/Image

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND CUSTOMER REPORTS DISPLAY WAS BLANK CURRENTLY. CUSTOMER STATES TRIED TO PLACE IN A NEW BATTERY BUT STILL NOT WORKING FULL BLACK SCREEN. CUSTOMER STATES THE PUMP WAS NEITHER EXPOSED TO EXTREME TEMPERATURES NOR DIRECT SUNLIGHT. 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: No Consequences Or Impact To Patient

  MAUDE report 8738658 ↗

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