MiniMed® 630G MMT-1715KL (UDI 00763000166519)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,492 adverse event reports that list this exact device (DI 00763000166519), received between Jan 2, 2019 and Jun 25, 2025 — classified as 10 deaths, 681 injuries, 1,801 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (714 reports).

2 FDA recall records name this device's identifier, 2 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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,492 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED ISSUES WITH THE INSULIN PUMP OVERHEATING. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715KL. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER REPORTED THAT EVEN AFTER CHANGING THE BATTERY 5 TIMES STILL THE PUMP WAS NOT TURNING ON. 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 22325885 ↗
• MalfunctionAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT UNABLE TO UPLOAD/DOWNLOAD 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 15145693 ↗
• MalfunctionJul 28, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS LOOSE AND FALLING OFF. THE LOCATION OF DAMAGE WAS THE RESERVOIR LIP RING. 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 15120137 ↗
• MalfunctionJul 25, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS CRACK AND DAMAGED. THE LOCATION OF DAMAGE WAS THE RESERVOIR RING. 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 15093694 ↗
• MalfunctionJul 22, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  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 15083153 ↗
• MalfunctionJul 22, 2022Connection Problem; Connection 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 15081575 ↗
• MalfunctionJul 20, 2022Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT NO DELIVERY/OCCLUSION ALARM - UNKNOWN TIMING OCCURRED. THERE WAS AN ALLEGATION OF HYPERGLYCEMIA AS A RESULT OF THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 15064669 ↗
• DeathJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT NO DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS AN ALLEGATION OF DEATH AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 15039633 ↗
• DeathJul 18, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2018 IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2018 DUE TO HEART ATTACK . THE CAUSE OF DEATH WAS HEART ATTACK. THE CALLER STATED THAT THE CUSTOMER HAD DIABETES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE AUTO MODE ON THE INSULIN PUMP WAS NOT ACTIVE. THE INSULIN PUMP HAD BEEN DISCONNECTED ON (B)(6) 2018 PRIOR TO PASSING. THE CALLER RETURNED THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Myocardial Infarction

  MAUDE report 15038464 ↗
• MalfunctionJul 14, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS AN ALLEGATION OF REACTION, INJECTION SITE AS A RESULT OF THIS EVENT.

  Patient problems: Administration Site Reaction

  MAUDE report 15010329 ↗
• MalfunctionJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR HAD AIR BUBBLES. CUSTOMER STATED THAT THEY WERE HOSPITALIZED DUE TO HEART ATTACK. CUSTOMER STATED THAT APPROXIMATE SIZE OF AIR BUBBLES WAS THE SIZE OF THE OPENING OF A PEN. THE RESERVOIR WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 14984735 ↗
• MalfunctionJul 12, 2022Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Insufficient Flow or Under Infusion; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 14984361 ↗
• MalfunctionJul 8, 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 14955563 ↗
• MalfunctionJul 8, 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 14955132 ↗
• MalfunctionJul 8, 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 14954854 ↗
• MalfunctionJul 8, 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 14954819 ↗
• MalfunctionJul 8, 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 14954689 ↗
• MalfunctionJul 8, 2022Break

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS AN ALLEGATION OF HYPERGLYCEMIA AS A RESULT OF THIS EVENT.

  Patient problems: Hyperglycemia

  MAUDE report 14954268 ↗
• MalfunctionJul 8, 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 14954252 ↗
• MalfunctionJul 8, 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 14954124 ↗
• MalfunctionJul 8, 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 14954107 ↗
• MalfunctionJul 8, 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 14954087 ↗
• MalfunctionJul 8, 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 14954069 ↗
• MalfunctionJul 8, 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 14953923 ↗
• MalfunctionJul 8, 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 14953430 ↗

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-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-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.