MiniMed® 530G MMT-551NAP (UDI 00643169503656)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,246 adverse event reports that list this exact device (DI 00643169503656), received between May 12, 2017 and Apr 29, 2026 — classified as 5 deaths, 377 injuries, 864 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (265 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 1,246 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA. THE CUSTOMER ALSO REPORTED AN UNSPECIFIED ISSUE. BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 45 MG/DL. THE EVENT INVOLVED PRODUCT(S) MMT-551NAP. TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN WHETHER THE CUSTOMER WAS USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. IT IS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-551NAP WAS REQUESTED, AND THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 25026537 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER REPORTED INSULIN PUMP WAS DAMAGE (PHYSICAL OR COSMETIC). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-551NAP. TROUBLESHOOTING WAS PERFORMED IT WAS REPORTED LOCATION OF THE DAMAGE IS AT BATTERY COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT MMT-551NAP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19474244 ↗
• MalfunctionAug 23, 2021Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A DAMAGED RETAINER RING. CUSTOMER STATES THAT A PIECE OF PLASTIC FELL OFF THE RIM OF THE RESERVOIR COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12356993 ↗
• MalfunctionOct 13, 2020Loss of Data; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PUMP ERROR 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 10675605 ↗
• MalfunctionSep 18, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED SCRATCHES ON SCREEN AND BATTERY CAP AREA. INSULIN PUMP RECEIVED 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 10552560 ↗
• MalfunctionSep 9, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALARMS, THE SCREEN AND THE RESERVOIR CAP WAS SCRATCHED. 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 10512498 ↗
• MalfunctionAug 31, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY WHEN THERE WAS INSULIN IN RESERVOIR. CUSTOMER DECLINED TROUBLESHOOTING. 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 10474744 ↗
• MalfunctionAug 12, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING HAD CRACK. THE TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND FOUND THAT THE RESERVOIR WAS LOCKING IN 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 10394582 ↗
• MalfunctionAug 11, 2020No Display/Image; Power Problem; Patient Device Interaction Problem; No Display/Image; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER STATED THAT WHILE PERFORMING SELF TEST INSULIN PUMP DEAD. INSULIN PUMP HAD CRACKS ON BATTERY. INSULIN PUMP HAD BATTERY FAILED ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10389437 ↗
• MalfunctionAug 6, 2020Mechanical Problem; Obstruction of Flow; Insufficient Device Problem Information; Mechanical Problem; Obstruction of Flow; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. INSULIN PUMP HAD NO DELIVERY ALARM. INSULIN PUMP HAD INSULIN PUMP ERROR 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 10372243 ↗
• MalfunctionAug 5, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS WERE STICKING. CUSTOMER STATED THAT THE INSULIN PUMP HAD TO REWIND MULTIPLE TIME. CUSTOMER STATED THAT THE BATTERY COMPARTMENT WAS CRACKED. 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 10366972 ↗
• MalfunctionAug 4, 2020Failure to Cycle; Detachment of Device or Device Component; Patient Device Interaction Problem; Failure to Cycle; Detachment of Device or Device Component; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 10362819 ↗
• MalfunctionAug 4, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS DID NOT RESPOND THE FIRST TIME. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD TO REWIND MORE THAN ONCE. 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 10361330 ↗
• MalfunctionAug 3, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Priming Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR, SQUIRTED INSULIN WHILE PRIMING, UNEXPLAINED NO DELIVERY ALARMS, HAD REJECTED NEW BATTERIES AND BATTERY CAP WAS MISSING. 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 10355798 ↗
• MalfunctionJul 31, 2020No Display/Image; Battery Problem; Power Problem; Patient Device Interaction Problem; No Display/Image; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY SCREEN. THE CUSTOMER ALSO STATED THAT, THE INSULIN PUMP HAD FAILED BATTERY, BATTERY OUT LIMIT AND LOW BATTERY 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 10349499 ↗
• MalfunctionJul 30, 2020Device Alarm System; Device Difficult to Program or Calibrate; Device Alarm System; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT BUTTONS OF INSULIN PUMP GETTING HARDER TO PRESS. CUSTOMER STATED THAT INSULIN PUMP WAS JUST START VIBRATING WITHOUT A REASON. 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 10343219 ↗
• MalfunctionJul 28, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR AND BATTERY SIDE WAS CRACKED. CUSTOMER STATED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP. 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 10331045 ↗
• MalfunctionJul 23, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THE BATTERY WAS CHANGED MULTIPLE TIMES, BUT THE ISSUE WAS NOT RESOLVED. 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 10313100 ↗
• InjuryJul 22, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WERE EXPERIENCING HIGH BLOOD GLUCOSE AND NO DELIVERY ALARMS. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 400 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER STATED THE INSULIN EXITED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10306406 ↗
• MalfunctionJul 21, 2020Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A ERROR MESSAGE FROM RESERVOIR REFILL. CUSTOMER STATED THAT RUBBER BUTTON ON BOTTOM WAS CAME OUT AND THEY PUSHED IT BACK IN. CUSTOMER PUT SILICON CASE BACK OVER IT. 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 10301003 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 416 MG/DL. CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVEL OF 335 MG/DL. CUSTOMER BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10300742 ↗
• MalfunctionJul 16, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. BATTERY CAP HAD WORN OUT. 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 10281967 ↗
• MalfunctionJul 16, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN RESERVOIR WAS BROKEN OFF AT THE TOP. CUSTOMER STATED UNEXPLAINED NO DELIVERY ALARMS. CUSTOMER ALSO REPORTED THAT REWIND WAS SLOW DOWN. TROUBLESHOOTING WAS UNKNOWN. 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 10281473 ↗
• InjuryJul 16, 2020Detachment of Device or Device Component; No Apparent Adverse Event; Patient Device Interaction Problem; Priming Problem; Detachment of Device or Device Component; No Apparent Adverse Event; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE THEY EXPERIENCED DIABETIC KETOACIDOSIS. THE CUSTOMER¿S BLOOD GLUCOSE WAS 204 MG/DL AND 300 MG/DL. THE CUSTOMER STATED DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER STATED RETAINER RING WAS CRACKED AND RESERVOIR WAS ABLE TO LOCK IN PLACE. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. CUSTOMER WAS UNABLE TO COMPLETE THE REWIND PROCESS ON THERE INSULIN PUMP, CUSTOMER STUCK ON FILL TUBING. CUSTOMER WAS REPORTING AN ISSUE DURING PRIMING PROCESS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10281381 ↗
• MalfunctionJul 14, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE TOP OF BATTERY AND RESERVOIR COMPARTMENT HAD BROKEN PIECES. CUSTOMER STATED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP. 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 10269674 ↗

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