MiniMed® 630G MMT-1715K (UDI 00763000316631)Recalls & reported problems

Summary

The FDA's MAUDE database contains 781 adverse event reports that list this exact device (DI 00763000316631), received between Nov 28, 2019 and Jun 29, 2022 — classified as 8 deaths, 368 injuries, 405 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (107 reports).

3 FDA recall records name this device's identifier, 3 still open.

21 other recalls cover devices cleared under the same FDA submission (P150001, P160017); 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-1748-2026 · 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 781 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2022Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BATTERY CAP CRACKED/DAMAGED OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851079 ↗
• MalfunctionJun 28, 2022Material Integrity Problem; Patient Device Interaction Problem; Material Integrity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BATTERY CAP AND THE RETAINER RING WAS MISSING. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK INTO PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14839958 ↗
• MalfunctionJun 26, 2022No Display/Image; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BLANK DISPLAY, BATTERY CAP CRACKED/DAMAGED OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14823851 ↗
• MalfunctionJun 26, 2022No Display/Image; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BLANK DISPLAY, BATTERY CAP CRACKED/DAMAGED OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14823013 ↗
• MalfunctionJun 26, 2022No Display/Image; Material Integrity Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT FAILED BATT TEST, BATTERY CAP CRACKED/DAMAGED, BLANK DISPLAY OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14822916 ↗
• MalfunctionJun 24, 2022No Display/Image; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BLANK DISPLAY, BATTERY CAP CRACKED/DAMAGED OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14797293 ↗
• MalfunctionJun 24, 2022Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BATTERY CAP CRACKED/DAMAGED OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14797061 ↗
• MalfunctionJun 24, 2022No Display/Image; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BATTERY CAP CRACKED/DAMAGED, BLANK DISPLAY OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14797010 ↗
• MalfunctionJun 24, 2022No Display/Image; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BATTERY CAP CRACKED/DAMAGED, BLANK DISPLAY OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14796046 ↗
• MalfunctionJun 24, 2022Battery Problem; Material Integrity Problem; Moisture or Humidity Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION THAT CHARGE/BATTERY LASTS LESS THAN EXPECTED, EXPOSED TO MOISTURE, FAILED BATT TEST, BATTERY CAP CRACKED/DAMAGED OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14796024 ↗
• MalfunctionJun 23, 2022Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BATTERY CAP CRACKED/DAMAGED OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14795278 ↗
• MalfunctionJun 23, 2022No Display/Image; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BATTERY CAP CRACKED/DAMAGED, BLANK DISPLAY OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14795174 ↗
• MalfunctionJun 23, 2022Break

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14793866 ↗
• MalfunctionMay 6, 2022Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS IDENTIFIED THAT THE USER WAS NOT AWARE OR HAD FORGOTTEN HIS BASAL PROGRAMMING. THE CUSTOMER REPORTED THAT THEIR BLOOD GLUCOSE WAS GOING UP AND THEY HAD ALREADY DONE THE INSULIN PUMP PROGRAMMING BUT THEY MAY HAVE NOT ENTERED THE BASAL RATES. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 14312515 ↗
• MalfunctionMay 4, 2022Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS IDENTIFIED THAT THE CUSTOMER'S BASAL PROGRAMMING WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF HIGH BLOOD GLUCOSE EVENT WAS 300 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER DECLINED TO CHECK FOR THE PRESENCE OF LEAKS OR AIR BUBBLES/TUBINGS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 14282455 ↗
• MalfunctionApr 28, 2022Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS IDENTIFIED THAT THE CUSTOMER'S BASAL PROGRAMMING WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE SINCE THEY PROGRAMMED THE INSULIN PUMP. THE CUSTOMER BLOOD GLUCOSE AT THE TIME OF THE EVENT WAS 200 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER INDICATED THEY DOES NOT HAVE A BASAL SET UP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 14240464 ↗
• MalfunctionApr 21, 2022Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS IDENTIFIED THAT THE CUSTOMER¿S BASAL PROGRAMMING WAS UNKNOWN. CUSTOMER WAS HIGH UP TO 380 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS TREATED WITH INJECTION. CUSTOMER REPORTED BASAL RATES ARE PROGRAMMED INACCURATELY. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: Hyperglycemia

  MAUDE report 14165849 ↗
• MalfunctionApr 21, 2022Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS IDENTIFIED THAT THE CUSTOMER¿S BASAL PROGRAMMING WAS UNKNOWN. CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE UPTO 300 MG/DL. CUSTOMER DID NOT HAVE BASAL PROGRAMMED INTO THE INSULIN PUMP. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS TREATED WITH REGULAR SHOTS. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: Hyperglycemia

  MAUDE report 14165422 ↗
• MalfunctionSep 21, 2021Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING OF THE INSULIN PUMP HAD DISCONNECTED FROM RESERVOIR COMPARTMENT. RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505282 ↗
• MalfunctionSep 21, 2021Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING OF THE INSULIN PUMP IS MISSING. RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505131 ↗
• MalfunctionSep 21, 2021Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING OF THE INSULIN PUMP WAS MISSING. RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 12504950 ↗
• MalfunctionSep 21, 2021Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING OF THE INSULIN PUMP IS BROKEN. RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12504922 ↗
• MalfunctionSep 21, 2021Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING OF THE INSULIN PUMP WAS FALLING OFF. THE INSULIN PUMP WAS NEITHER BUMPED NOR DROPPED. RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12503439 ↗
• MalfunctionSep 20, 2021Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD DAMAGE ON THE RETAINER RING. CUSTOMER STATED THAT THE RETAINER RING WAS MISSING. IT WAS REPORTED THAT THE RESERVOIR ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12499894 ↗
• MalfunctionSep 20, 2021Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD DAMAGE ON THE RETAINER RING. CUSTOMER STATED THAT THE PUMP HAD COSMETIC DAMAGE. IT WAS REPORTED THAT THE RESERVOIR ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494608 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150001, P160017. One submission often covers many models, so check the product and lot details in each record.

• Z-2981-2026 · Jul 13, 2026 · Open, Classified
  MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
• Z-1740-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• Z-1742-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
• Z-1739-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
• Z-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• Z-1265-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
• Z-1261-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
• Z-1266-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
• Z-0003-2025 · Jul 31, 2024 · Open, Classified
  MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G
• Z-0193-2023 · Sep 20, 2022 · Open, Classified
  Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
• 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-1771-2021 · Mar 15, 2021 · Open, Classified
  MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE SF M
• Z-0516-2021 · Apr 30, 2020 · Open, Classified
  MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under
• 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-0956-2020 · Nov 21, 2019 · Open, Classified
  Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MM

…and 6 more.