MiniMed® 530G MMT-551PNAHRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169507272), received between Jun 21, 2017 and Jan 29, 2019 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BATTERY COMPARTMENT AREA WAS CRACK. CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE PUMP WILL BE REPLACED AS PER TROUBLESHOOT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284251 ↗
• InjuryOct 15, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 520 MG/DL, OVER 400 MG/DL AND 560 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT THE INSULIN PUMP HAD CRACK ON THE TOP RIGHT HAND CORNER FRONT TO THE SIDE 1/2 INCH, UNDER ESC BUTTON INTO THE WINDOW WHERE 1 INCH, BATTERY COMPARTMENT ON THE THREAD PART OF THAT OPENING. CUSTOMER DECLINE TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. 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: Hyperglycemia

  MAUDE report 7964576 ↗
• MalfunctionJun 18, 2018Failure to Deliver; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS DELIVERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 230 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7608987 ↗
• InjuryJun 21, 2017Air Leak; Bent

  THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. THE CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 398 MG/DL AND IT WAS ALSO THE SAME READING AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT SHE HAS NOT TREATED YET. THE RECENT HIGH BLOOD GLUCOSE EVENT BEGAN ON (B)(6) 2017. TROUBLESHOOTING WAS PERFORMED AND AIR BUBBLES WERE FOUND ALONG THE TUBING LENGTH. CUSTOMER STATED THAT THE INSULIN EXITED AT THE QUICK RELEASE. CUSTOMER WAS ADVISED THAT POSITIONING IN THE MOTOR MAY HAVE SHIFTED. THE AIR BUBBLES WERE NOT SUCCESSFULLY REMOVED. CUSTOMER WAS ADVISED TO DO A COMPLETE SET CHANGE TO RESOLVE THE NO DELIVERY AND AIR BUBBLE ISSUE. CUSTOMER ALSO REPORTED THAT SHE HAD A BENT SENSOR. CUSTOMER WAS ADVISED THAT THE SENSOR MAY NOT BE WORKING OR MAY BE DAMAGED. THE RESERVOIR AND THE SENSOR WILL BE RETURNED FOR ANALYSIS. THE INSULIN PUMP WILL NOT BE RETURNED.

  Patient problems: Hyperglycemia

  MAUDE report 6658946 ↗
• MalfunctionJun 21, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD LOW BATTERY AND SENSOR END ALERTS. THE CUSTOMER¿S BLOOD GLUCOSE WAS 150 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATES THEY WERE TRYING TO REWIND BUT THE INSULIN PUMP BEGAN TO ALARM. THE CUSTOMER STATED THE BUTTONS WERE HARD TO PUSH AND NOW THEY ARE NOT WORKING. THE CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES, FOUND TIME IS STILL ADVANCING. CUSTOMER WAS ALSO CALLING BACK AFTER LETTING THE INSULIN PUMP REST FOR TWO HOURS DUE TO A CONSTANT TONE. CUSTOMER STATED THE BUTTONS WERE NOT FUNCTIONAL. 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 6658422 ↗

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