MiniMed® 630G MMT-1715K (UDI 00763000190439)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7,947 adverse event reports that list this exact device (DI 00763000190439), received between Oct 2, 2018 and Sep 30, 2024 — classified as 36 deaths, 2,287 injuries, 5,624 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2,328 reports).

4 FDA recall records name this device's identifier, 4 still open.

9 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 13, 2026Open, 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 · FDA record ↗

2. Jul 31, 2024Open, 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 · FDA record ↗

3. Jul 31, 2024Open, 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 · FDA record ↗

4. May 23, 2022Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 7,947 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2024Battery Problem; Power Problem; Battery Problem; Power Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER REPORTED UNEXPECTED BATTERY POWER LOSS ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-1715K. TROUBLESHOOTING WAS PERFORMED AND REPLACED PUMP. THE CUSTOMER ALSO RECEIVED LOW BATTERY ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE. MMT-1715K WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20331050 ↗
• MalfunctionJan 10, 2024Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED AN INSULIN FLOW BLOCK ALARM. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE TUBING WAS NOT BENT OR KINKED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP AND THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18482817 ↗
• DeathJun 5, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC LEGAL RECEIVED INFORMATION ON (B)(6) 2023. INFORMATION RECEIVED INDICATED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND PASSED AWAY ON (B)(6) 2023. THE CUSTOMER HAS WORN THE PUMP AT THE TIME OF PASSING. TROUBLESHOOTING WAS PARTIALLY PERFORMED AND FOUND THAT CAUSE OF PASSING WAS HYPOGLYCEMIA. THE CUSTOMER PASSED AWAY AT HOME. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Insufficient Information

  MAUDE report 17057132 ↗
• MalfunctionMay 29, 2023Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 214 MG/DL AT THE TIME OF THE EVENT AND REPORTED DAMAGE TO THE INSULIN PUMP'S RETAINER RING. TROUBLESHOOTING WAS PARTIALLY PERFORMED AND LATER DECLINED AND FOUND THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE PUMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE AND WAS ADVISED TO REVERT TO THE BACKUP PLAN AS PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 17016202 ↗
• MalfunctionApr 14, 2023Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED AN INSULIN FLOW BLOCK AND A RESERVOIR REPLACEMENT. NO FURTHER DETAILS WERE PROVIDED. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE PUMP AND THE PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740622 ↗
• MalfunctionAug 9, 2022Break; Break

  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 15196528 ↗
• MalfunctionAug 2, 2022Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE LIP RING WAS MOVING WHEN THE RESERVOIR WAS BEING UNLOCKED. THE RETAINER RING WAS DAMAGED. THE LOCATION OF DAMAGE WAS THE LIP RING. THE RESERVOIR WAS ABLE TO LOCK IN PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145922 ↗
• MalfunctionAug 2, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS CRACKED. IT WAS STATED THAT THE BATTERY PART WAS CRACKED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145629 ↗
• MalfunctionAug 2, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A CRACKED BATTERY COMPARTMENT. THE RETAINER RING HAD NO DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DSICONTINUE TO USE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143920 ↗
• MalfunctionAug 2, 2022Break; Break

  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 15143755 ↗
• MalfunctionAug 2, 2022No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A DAMAGED RETAINER RING. THE CUSTOMER REPORTED CRACK IN RESERVOIR COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143643 ↗
• MalfunctionAug 2, 2022No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED DISPLAY WAS BLANK CURRENTLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE PUMP. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143611 ↗
• MalfunctionJul 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  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 15121001 ↗
• MalfunctionJul 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS DAMAGED . NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120774 ↗
• MalfunctionJul 28, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS LOOSED. THE RESERVOIR WAS ABLE TO LOCK IN THE PLACE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NEITHER BEEN BUMPED NOR DROPPED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120338 ↗
• MalfunctionJul 28, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS DAMAGED AND LOOSEN AND TOP OF THE INSULIN PUMP WAS DAMAGED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15119740 ↗
• MalfunctionJul 28, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS MOOSE, MISSING AND DAMAGED. THE LOCATION OF DAMAGE WAS THE RESERVOIR LIP RING. THE TYPE OF DAMAGE WAS CRACK. THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15119717 ↗
• MalfunctionJul 28, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER LIP RING WAS DAMAGED. CUSTOMER STATED THAT THE LIP RING CAME OFF DURING THE RESERVOIR CHANGE. THE RESERVOIR WAS ABLE TO LOCK IN PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED, THE CUSTOMER WILL DISCONTINUE THE USE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15119690 ↗
• MalfunctionJul 25, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP WAS DAMAGE AND THE LOCATION OF DAMAGE WAS HINGES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS NOT PERFORMED. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092277 ↗
• MalfunctionJul 25, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS DAMAGE. THE TYPE OF DAMAGE WAS CRACK AND THE LOCATION OF DAMAGE WAS THE RESERVOIR COMPARTMENT. THE INSULIN PUMP WAS CRACK NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED, THE CUSTOMER WILL DISCONTINUE THE USE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092152 ↗
• MalfunctionJul 25, 2022Break; Break

  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 15091983 ↗
• MalfunctionJul 22, 2022Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT NO DELIVERY/OCCLUSION ALARM - UNKNOWN TIMING 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 15083611 ↗
• MalfunctionJul 22, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SHOW SIGNS OF PHYSICAL DAMAGE. THE CLIP RAIL WAS CRACKED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15083154 ↗
• MalfunctionJul 20, 2022Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED INSULIN FLOW BLOCKED. THE PUMP PASSED SELF TEST AND DISPLACEMENT TEST. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 15063718 ↗
• MalfunctionJul 20, 2022Break; Break

  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 15063612 ↗

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-1740-2026 · Feb 13, 2026 · Open, Classified
  MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• Z-1259-2025 · Jan 31, 2025 · Open, Classified
  MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
• 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-18
• 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.