MiniMed® 530G MMT-551NAL (UDI 00643169503649)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,938 adverse event reports that list this exact device (DI 00643169503649), received between May 10, 2017 and Jul 11, 2023 — classified as 6 deaths, 548 injuries, 1,384 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (373 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 1,938 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THE CUSTOMER REPORTED THE RESERVOIR CAP WAS BROKEN ON AN INSULIN PUMP AND THE RESERVOIR LIP WAS ALSO DAMAGED. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE AND THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295766 ↗
• MalfunctionJan 24, 2021Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALARMS. NO HARM WAS REQUIRED DURING MEDICAL INTERVENTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 11221125 ↗
• MalfunctionOct 6, 2020Display or Visual Feedback Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS CRACKED AT THE RESERVOIR COMPARTMENT. CUSTOMER REPORTED FAILED BATTERY TO THE INSULIN PUMP. THE BACK LIGHT WAS DIMMER. 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 10633488 ↗
• MalfunctionSep 17, 2020Communication or Transmission Problem; Patient Device Interaction Problem; Communication or Transmission Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP DID TWO HAIR LINE FRACTURES, ONE ALONG THE BATTERY CLOSURE AND ONE ABOVE THE SCREEN. 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 10545323 ↗
• MalfunctionAug 20, 2020Mechanical Problem; Battery Problem; Power Problem; Priming Problem; Mechanical Problem; Battery Problem; Power Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD FALSE/UNEXPLAINABLE NO DELIVERY ALARMS, HAD REJECTED NEW BATTERIES, AND HAD BEEN REQUIRED TO PRIME/REWIND MORE THAN ONCE. 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 10429434 ↗
• MalfunctionAug 12, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Power Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARDER TO PUSH AND BACK BUTTON WAS LESS RESPONSIVE. CUSTOMER STATED THAT THE INSULIN PUMP BACKLIGHT WONT CAME ON. INSULIN PUMP REJECTED NEW BATTERIES AND BATTERY CAP WAS REPLACED TWICE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394912 ↗
• MalfunctionAug 11, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED ERROR AND BLANK SCREEN. CUSTOMER WAS ABLE TO CLEAR ALARM. CUSTOMER DID NOT RECEIVED REWIND PROCESS. 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 10389228 ↗
• MalfunctionAug 6, 2020Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR AND RESERVOIR LIP RING CAME OFF. THE CUSTOMER STATED INSULIN PUMP REJECTED NEW ROOM TEMPERATURE BATTERIES. 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 10377226 ↗
• MalfunctionAug 5, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM 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 10366973 ↗
• MalfunctionAug 5, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10366726 ↗
• MalfunctionAug 4, 2020Mechanical Problem; Obstruction of Flow; Power Problem; Mechanical Problem; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. INSULIN PUMP HAD NO DELIVERY ALARM. INSULIN PUMP REJECTED NEW BATTERIES. 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 10361258 ↗
• MalfunctionAug 4, 2020Battery Problem; Power Problem; Patient Device Interaction Problem; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SCRATCHES ON SCREEN HAD TO TILT TO READ SEVERE. THE INSULIN PUMP HAD BATTERY LIFE RUNNING THROUGH NEW BATTERIES FASTER THAN BEFORE AND ALSO HAD FAILED TESTS AND REJECTED BATTERY AND ERROR MESSAGES. 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 10361085 ↗
• MalfunctionAug 4, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SQUIRTED INSULIN DURING PRIMING. 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 10360915 ↗
• MalfunctionJul 31, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING FILL TUBING. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. 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 10348678 ↗
• InjuryJul 30, 2020Failure to Cycle; No Apparent Adverse Event; Failure to Cycle; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 468 MG/DL AT THE TIME OF INCIDENT. THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE ALARM OCCURRED DURING PRIMING. THE CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10343245 ↗
• MalfunctionJul 30, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Insufficient Device Problem Information; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND E ERROR CODE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT INSULIN PUMP HAD BUTTONS ARE NON RESPONSIVE AND INSULIN SQUIRTING OUT DURING PRIME. THE INSULIN PUMP GRINDING DURING REWIND PROCESS AND DIMINISHED BATTERY LIFE FROM DAY 1 USED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10342736 ↗
• MalfunctionJul 28, 2020Device Alarm System; Battery Problem; Patient Device Interaction Problem; Device Alarm System; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A DAMAGED DISPLAY AND RAINBOW EFFECT WHICH MAKE IT HARD TO READ. CUSTOMER STATED THAT THERE WAS RANDOM NO DELIVERY ALARM. CUSTOMER STATED THAT INSULIN PUMP DID NOT GAVE LOW BATTERY WARNINGS. 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 10331635 ↗
• MalfunctionJul 28, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THEY WERE UNABLE TO CLEAR THE ALARM. THEY WERE UNABLE TO REWIND THE INSULIN PUMP. CUSTOMER REPORTED THE HISTORY OF MOTOR AND MOTOR PISTON ENCODE ERROR ALARMS. 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 10331103 ↗
• MalfunctionJul 21, 2020Premature Discharge of Battery; No Display/Image; Loss of Data; Intermittent Communication Failure; Premature Discharge of Battery; No Display/Image; Loss of Data; Intermittent Communication Failure

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY SCREEN. THE CUSTOMER ALSO STATED THAT, THE CUSTOMER RECEIVED WITH AN MULTIPLE INSULIN PUMP ERRORS. THE INSULIN PUMP WAS ABLE TO REWIND. THE UNEXPECTED RESTART ALARM WAS REOCCURRED WHEN INSULIN PUMP WAS IN 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 10300458 ↗
• MalfunctionJul 20, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Priming Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SQUIRTS INSULIN DURING PRIME ANS SOMETIMES HAD TO HIT BUTTONS MORE THAN ONCE TO GET THEM TO RESPOND ACT BUTTON. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND BROWN DISCOLORATION ON OPPOSITE SIDE OF BATTERY IN. 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 10295878 ↗
• MalfunctionJul 20, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER STATED THAT THEY WAS ABLE TO REWIND INSULIN PUMP BUT NUMBER DID NOT DISPLAY. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NOT NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10294229 ↗
• MalfunctionJul 16, 2020Mechanical Problem; Detachment of Device or Device Component; Environmental Compatibility Problem; Mechanical Problem; Detachment of Device or Device Component; Environmental Compatibility Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. DRIVE SUPPORT CAP WAS FLUSH. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10281785 ↗
• InjuryJul 16, 2020Adverse 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 LEVEL OF 500 MG/DL. THE CUSTOMER WAS ONLY OFF INSULIN PUMP FOR FEW HOURS AND NOT FOR MORE THAN 48 HOURS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10281243 ↗
• MalfunctionJul 15, 2020Mechanical Problem; Priming Problem; Mechanical Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SQUIRTING INSULIN. THE CUSTOMER STATED THAT THE INSULIN SQUIRTS ON OCCASION AND IT WAS PRIME OR REWIND AGAIN. 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 10281188 ↗
• MalfunctionJul 15, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY 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 10274931 ↗

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