MiniMed® 630G MMT-1755KRRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000179632), received between Feb 12, 2019 and Jul 12, 2022 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Power Problem” (3 reports).

5 FDA recall records name this device's identifier, 5 still open.

7 other recalls cover devices cleared under the same FDA submission (P150001); 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.

Recalls naming this device

1. Feb 13, 2026Class IIOpen, Classified

   All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

   Z-1740-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 31, 2024Class IOpen, Classified

   Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

   Z-0001-2025 · Root cause: Device Design · Recall details · FDA record ↗

3. Jul 31, 2024Class IOpen, Classified

   Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

   Z-0002-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. Sep 20, 2022Class IIOpen, Classified

   Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.

   Z-0193-2023 · Root cause: Component change control · Recall details · FDA record ↗

5. May 23, 2022Class IIOpen, Classified

   Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.

   Z-1353-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THEY RECEIVED AUTO SUSPEND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14984041 ↗
• MalfunctionJul 15, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS FELL OFF. THE CUSTOMER STATED THAT THE RESERVOIR DID LOCK INTO PLACE. CUSTOMER STATED THAT THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER STATED THAT THE RESERVOIR AND INSULIN PUMP DOES NOT SHOW SIGNS OF DAMAGE. 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 10274696 ↗
• MalfunctionJun 25, 2020Moisture or Humidity Problem; Power Problem; Moisture or Humidity Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR ALARM. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD OPEN BOOK IMAGE ON THE SCREEN. CUSTOMER JUMPED INTO THE POOL AND INSULIN PUMP MALFUNCTIONED. CUSTOMER MENTIONED THAT THERE WERE NO ANY OTHER ALARMS DISPLAYED PRIOR TO OPEN BOOK IMAGE ON 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 10193944 ↗
• MalfunctionJun 5, 2020Power Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD OPEN BOOK IMAGE ON THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10123636 ↗
• MalfunctionJan 30, 2020No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DISPLAY WAS FLASHING WHITE. CUSTOMER STATED THAT THE INSULIN PUMP HAD BLANK DISPLAY AFTER RECEIVING THE NEW BATTERY CAP. 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 9645967 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCE HYPERGLYCEMIA AND THIRSTY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 517 MG/DL, 493 MG/DL AND 159 MG/DL AT TIME OF INCIDENT. CUSTOMER REPORTED THAT THEY DID NOT FEEL OKAY TO TROUBLESHOOTING. CUSTOMER STATED THAT THEY DELIVERED CORRECTION INSULIN BOLUS BUT BLOOD GLUCOSE STILL GETTING HIGH. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9457586 ↗
• MalfunctionSep 19, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 206 MG/DL. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS NOT ABLE TO COMPLETE REWIND. CUSTOMER WAS ADVISED TO PLACE INSULIN PUMP IN STORAGE MODE. THE CUSTOMER WAS ALSO ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9096148 ↗
• MalfunctionJul 8, 2019No Display/Image; Power Problem; No Display/Image; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD REPLACE BATTERY ALARM BUT WHEN HE CHANGED THE BATTERY THE SCREEN WAS NOT TURNING BACK ON. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS TRIED 3 DIFFERENT FRESH NEW BATTERIES BUT IT'S STILL NOT WORKING. CUSTOMER STATED THE SCREEN TURNS OFF WHEN HE CLEAN THE BATTERY COMPARTMENT. CUSTOMER STATED THAT HE KEEPS GETTING THE INSERT NEW BATTERY ALERT EVEN IF HE CHANGED THE BATTERY BUT IT WENT TO A BLANK DISPLAY AGAIN AFTER SEEING THE INSERT NEW BATTERY ALERT. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP ARE NEITHER MISSING NOR DAMAGED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8766469 ↗
• InjuryMay 6, 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 HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 326 MG/DL. CUSTOMER HAD SYMPTOMS SUCH AS NAUSEA, DIFFICULTY BREATHING. CUSTOMER REPORTS THAT INSULIN EXITED WITH QUICK RELEASE. CUSTOMER DID NOT ALLEGE FOR UNDER DELIVERING. CUSTOMER STATED THAT THERE WAS NO AIR BUBBLE AND LEAK. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8581340 ↗
• InjuryMay 6, 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 HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 404 MG/DL AT THE TIME OF INCIDENT. CUSTOMER WAS EXPERIENCING FEVER AND DID CHEST XRAY AND MAY HAVE PNEUMONIA. CUSTOMER STATES THAT SHE WAS NOT FEELING WELL. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Fever; Hyperglycemia; Pneumonia

  MAUDE report 8581020 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8572159 ↗
• InjuryApr 24, 2019Device Alarm System; No Apparent Adverse Event; Device Alarm System; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AS WELL AS HYPOGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 363 MG/DL, 413 MG/DL, 400 MG/DL, 363 MG/DL, 214 MG/DL, 500 MG/DL, 405 MG/DL AND 27 MG/DL. CUSTOMER REPORTED THAT THE CANNULA WAS BENT. THE CUSTOMER DECLINED WITH TROUBLESHOOTING. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8543991 ↗
• MalfunctionFeb 12, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CORRECTION SUPPLEMENTAL IS REQUESTED TO UPDATE MMT # TO 630G INSULIN PUMP TO MMT-1715KR 630G.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8334139 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150001. One submission often covers many models, so check the product and lot details in each record.

• Z-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• Z-0855-2022 · Jan 27, 2022 · Open, Classified
  MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881
• Z-0517-2021 · Apr 30, 2020 · Open, Classified
  MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rate
• Z-0955-2020 · Nov 21, 2019 · Open, Classified
  Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
• Z-0683-2019 · Oct 3, 2018 · Open, Classified
  Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
• Z-2603-2017 · May 8, 2017 · Terminated
  MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
• Z-2602-2017 · May 8, 2017 · Terminated
  MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.