MiniMed® 630G MMT-1715K (UDI 00643169656840)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35,170 adverse event reports that list this exact device (DI 00643169656840), received between May 2, 2017 and Jul 3, 2025 — classified as 98 deaths, 8,232 injuries, 26,840 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (7,436 reports).

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

8 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. Sep 20, 2022Open, 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 · 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 35,170 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER ALSO REPORTED THAT THE A POTENTIAL UNDER-DELIVERY. THE CUSTOMER WAS TREATED WITH AN INSULIN PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-397 AND MMT-1715K. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER STATED THAT THE AIR BUBBLES IN THE TUBING LIMIT INSULIN DELIVERY. THE CUSTOMER DID NOT ALLOW THE INSULIN TO WARM TO ROOM TEMPERATURE BEFORE FILLING THE RESERVOIR AND WAS ADVISED TO CHANGE THE INFUSION SET AND RESERVOIR. THE CUSTOMER ALSO REPORTED CONSISTENTLY HIGH BLOOD GLUCOSE LEVELS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-397. NO PRODUCT RETURN IS REQUIRED FOR MMT-1715K.

  Patient problems: Hyperglycemia

  MAUDE report 22394343 ↗
• MalfunctionJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 368 MG/DL WHILE TRAVELING BY PLANE, WHICH LATER REDUCED TO 138 MG/DL AFTER TREATMENT WITH THE INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 368 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, INCLUDING VERIFYING PUMP SETTINGS AND ADVISING THE CUSTOMER ON POTENTIAL CONTRIBUTING FACTORS SUCH AS SITE ISSUES, INSULIN QUALITY, AND TUBING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1715K.

  Patient problems: Hyperglycemia

  MAUDE report 22394188 ↗
• MalfunctionJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 300 MG/DL. THE CUSTOMER WAS TREATED WITH AN INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, AND IT WAS UNKNOWN WHETHER THE INSULIN PUMP WAS UTILIZED WITHIN 48 HOURS OF THE EVENT; ALSO, IT WAS UNKNOWN WHETHER THE AUTO MODE FEATURE WAS ACTIVE OR NOT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 22393101 ↗
• MalfunctionJul 3, 2025Power Problem; Power Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED REPLACE BATTERY NOW ALARMS WITHOUT PRIOR LOW BATTERY ALERTS, WITH THE BATTERY DEPLETING RAPIDLY AFTER BEING REPLACED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED WHICH INCLUDED REVIEWING ALARM HISTORY, CONFIRMING THE USE OF NEW ALKALINE BATTERIES, AND VERIFYING THAT THE BATTERY CAP WAS NOT LOOSE, CRACKED, OR DAMAGED. THE ISSUE PERSISTED, AND THE PUMP WAS REPLACED. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP AND CONTINUE USING IT UNTIL THE REPLACEMENT ARRIVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392982 ↗
• MalfunctionJul 3, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED BATTERY LEAKAGE AND RECURRING REPLACE BATTERY ALARMS WITH THEIR INSULIN PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER REPORTED A BATTERY FAILED ALARM, AND THE ISSUE WAS ATTRIBUTED TO BATTERY LEAKAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392976 ↗
• MalfunctionJul 3, 2025Moisture or Humidity Problem; Key or Button Unresponsive/not Working; Moisture or Humidity Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED A BATTERY ISSUE AND A STUCK BUTTON ALARM WITH THEIR INSULIN PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER STATED THAT NO DAMAGE WAS FOUND ON THE BATTERY CAP AND BATTERY COMPARTMENT. ALSO, THE PUMP HAD BEEN EXPOSED TO MOISTURE AND CONTAINED FLUID IN THE BATTERY COMPARTMENT AND REQUIRED A REPLACEMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392502 ↗
• MalfunctionJul 3, 2025Moisture or Humidity Problem; Moisture or Humidity Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED CONDENSATION UNDER THE LCD SCREEN OF THE INSULIN PUMP AFTER OUTDOOR ACTIVITY. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, AND NO CRACKS OR EXTERNAL DAMAGE WERE FOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392214 ↗
• MalfunctionJul 3, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER OBSERVED A SMALL RED LIGHT UNDER THE BACK ARROW ON THE PUMP THAT REMAINED SOLID FOR APPROXIMATELY TWO MONTHS. THE LIGHT DID NOT FLASH DURING ALARMS, AND THE PUMP HAD NOT BEEN DROPPED OR BUMPED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS NOT PERFORMED, AND THE PUMP WAS REPLACED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392202 ↗
• MalfunctionJul 3, 2025Battery Problem; Wireless Communication Problem; Battery Problem; Wireless Communication Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER ALSO REPORTED A REPLACE BATTERY NOW ALARM WITH A PRIOR LOW BATTERY ALERT, THE BATTERY LIFE WAS SHORTER THAN EXPECTED, THE SENSOR DID NOT CONNECT WITH THE INSULIN PUMP. BLOOD GLUCOSE VALUE AT THE TIME OF EVENT WAS 347 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WILL BE PROVIDE WITH AN INSULIN PUMP REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER DISCONTINUED USE OF THE INSULIN PUMP. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 22392007 ↗
• MalfunctionJul 3, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED A REPLACE BATTERY NOW ALARM WITHOUT A PRIOR LOW BATTERY WARNING. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-1715K. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391994 ↗
• MalfunctionJul 3, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED RAPID BATTERY DEPLETION, WITH BATTERIES LASTING ONLY 36 HOURS DESPITE USING NEW ENERGIZER LITHIUM BATTERIES AND RECEIVING A REPLACEMENT BATTERY CAP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, WHICH INCLUDED REVIEWING ALARM HISTORY, VERIFYING BATTERY USAGE, AND SUGGESTING ADJUSTMENTS TO SETTINGS SUCH AS BACKLIGHT TIMEOUT AND SCREEN MANAGEMENT, BUT THE ISSUE PERSISTED. THE CUSTOMER WAS ADVISED TO REVERT TO THEIR BACKUP PLAN PER HCP INSTRUCTIONS AND PLACE THE PUMP IN STORAGE MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391930 ↗
• MalfunctionJun 27, 2025Break; Battery Problem; Break; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED TWO ISSUES WITH THE INSULIN PUMP: PHYSICAL DAMAGE WHERE THE CLIP ATTACHES AND RECURRING "REPLACE BATTERY NOW" ALARMS, REQUIRING BATTERY CHANGES EVERY OTHER DAY. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED AND THAT INCLUDED REVIEWING ALARM HISTORY, VERIFYING BATTERY USAGE, AND CONFIRMING THAT THE BATTERY CAP WAS NOT DAMAGED, BUT THE ISSUE PERSISTED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP, REVERT TO THEIR BACKUP PLAN PER HEALTHCARE PROFESSIONAL'S INSTRUCTIONS, AND INSERT NEW BATTERIES AS NEEDED UNTIL THE REPLACEMENT ARRIVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346704 ↗
• MalfunctionJun 27, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED MULTIPLE "LOW BATTERY" AND "REPLACE BATTERY NOW" ALARMS WITHIN 20 HOURS, WITH THE BATTERY BECOMING HOT UPON REMOVAL. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED AND WHICH INCLUDED REVIEWING ALARM HISTORY, VERIFYING THE USE OF DURACELL BATTERIES, AND CONFIRMING THAT THE BATTERY CAP WAS NOT LOOSE, CRACKED, OR DAMAGED, BUT THE ISSUE PERSISTED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346193 ↗
• MalfunctionJun 25, 2025Battery Problem; Material Integrity Problem; Battery Problem; Material Integrity Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED RECURRING "BATTERY FAILED" ALARM. THE CUSTOMER ALSO REPORTED A SMALL CRACK ALONG THE BACK OF THE PUMP EXTENDING FROM THE BATTERY CAP DOWN. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, WHICH INCLUDED REVIEWING ALARM HISTORY, CLEANING THE BATTERY COMPARTMENT, AND CONFIRMING NO DAMAGE OR CORROSION ON THE BATTERY CAP CONTACTS, BUT THE ISSUE PERSISTED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE, REVERT TO THE BACKUP PLAN PER THE HEALTHCARE PROFESSIONAL'S INSTRUCTIONS, AND PLACE THE PUMP IN STORAGE MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326232 ↗
• MalfunctionJun 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED REPEATED BATTERY FAILED ALARMS AND A LOW BATTERY INDICATOR DESPITE REPLACING THE BATTERY APPROXIMATELY 15 TIMES. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER STATED THAT NO DAMAGE TO THE BATTERY CAP CONTACTS OR COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326123 ↗
• MalfunctionJun 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED REPEATED BATTERY FAILED ALARMS AND REPLACE BATTERY ALERTS WITH THE INSULIN PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED THAT THE PUMP STOPPED WORKING. THE CUSTOMER STATED THAT THE BATTERY COMPARTMENT AND CAP WERE NOT DAMAGED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS REPLACED AND RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325866 ↗
• MalfunctionJun 25, 2025Overheating of Device; Battery Problem; Overheating of Device; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED THE INSULIN PUMP OVERHEATING AT THE BATTERY COMPARTMENT AND THE PUMP NOT HOLDING A CHARGE. THE ISSUE PERSISTED DESPITE REPLACING THE BATTERY AND BATTERY CAP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED AND INSTRUCTED TO REVERT TO A BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS AND PLACE PUMP IN STORAGE MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325848 ↗
• MalfunctionJun 25, 2025Break; Battery Problem; Break; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER¿S INSULIN PUMP HAD A CRACK IN THE BATTERY COMPARTMENT AND EXPERIENCED REPLACE BATTERY NOW ALARM WITHOUT A PRECEDING LOW BATTERY WARNING. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER REPORTED A PHYSICAL DAMAGE AND BATTERY-RELATED ISSUES, AND THE PUMP WAS DEEMED UNSUITABLE FOR USE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS REPLACED AND RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325775 ↗
• MalfunctionJun 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED POOR BATTERY LIFE, WITH THE BATTERY LASTING TWO WEEKS OR LESS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325661 ↗
• MalfunctionJun 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED RAPID BATTERY DEPLETION, WITH THE BATTERY LASTING ONLY 1-2 HOURS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PARTIALLY PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS REPLACED AND RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325574 ↗
• MalfunctionJun 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED REPEATED BATTERY FAILURES, WITH THE BATTERY LASTING ONLY 3-4 DAYS, COMPARED TO 2 WEEKS PREVIOUSLY. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE PERSISTED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS REPLACED AND RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325505 ↗
• MalfunctionJun 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED RAPID BATTERY DEPLETION, WITH BATTERIES LASTING LESS THAN ONE WEEK DESPITE USING NEW ENERGIZER LITHIUM BATTERIES. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, INCLUDING VERIFYING BATTERY USAGE, PUMP SETTINGS, AND ALARM HISTORY, BUT THE ISSUE PERSISTED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325436 ↗
• MalfunctionJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED ISSUES WITH THE ENLITE SENSOR, INCLUDING ERRORS DURING USE AND CALIBRATION NOT BEING ACCEPTED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-7008A AND MMT-1715K. TROUBLESHOOTING WAS PERFORMED, INCLUDING DISCUSSING PROPER SENSOR INSERTION, CALIBRATION PRACTICES, AND SECURING THE SENSOR WITH TAPE OR ADHESIVES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 22325404 ↗
• MalfunctionAug 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED BATTERY CAP DAMAGE OF THE INSULIN PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED INSULIN PUMP PRODUCT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT IS NOT EXPECTED TO RETURN FOR PRODUCT ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085433 ↗
• MalfunctionAug 28, 2024No Display/Image; Material Integrity Problem; No Display/Image; Material Integrity Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED BATTERY CAP DAMAGE OF THE INSULIN PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED INSULIN PUMP PRODUCT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT IS NOT EXPECTED TO RETURN FOR PRODUCT ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085419 ↗

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-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-2602-2017 · May 8, 2017 · Terminated
  MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
• Z-2603-2017 · May 8, 2017 · Terminated
  MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.