MiniMed®630G MMT-1755KRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000101527), received between Jan 18, 2019 and Jul 4, 2022 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (4 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. 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 4, 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 14904993 ↗
• MalfunctionJun 12, 2020Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR AND ALSO HAD ANOTHER INSULIN PUMP ERROR. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM. 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 10146901 ↗
• MalfunctionMay 9, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED WITH A BROKEN FORCE SENSOR DETECTED DURING SEATING OR REGULAR DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10041498 ↗
• MalfunctionFeb 12, 2020Device Alarm System; Device Alarm System

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AN AUDIO ANOMALY. THE CUSTOMER STATED THAT THE DEVICE WAS NOT MAKING ANY SOUND WHEN ALARMING. THEY DID NOT HEAR BEEPS WHEN THE AUDIO VOLUME SETTINGS WERE SAVED. THE DEVICE FAILED THE AUDIO TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9697724 ↗
• InjuryJan 15, 2020Adverse 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 THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER STATED THAT THEY CANNOT FIND SENSOR SIGNAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9589849 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AND WAS TREATED WITH INSULIN PUMP. THE CUSTOMER ALSO REPORTED THAT IT KEPT ON SAYING CANNOT FIND SENSOR SIGNAL AND ALSO RECEIVED LOSS OF COMMUNICATION. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9589794 ↗
• InjuryOct 23, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT HER DAUGHTER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 496 MG/DL. THE CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 163 MG/DL. CUSTOMER WAS FIRST ADMITTED TO A LOCAL CLINIC AND BECAUSE THEY DID NOT HAD ALL THE EQUIPMENT THEY MOVED HER TO A LOCAL HOSPITAL AND BECAUSE BLOOD GLUCOSE STAYED HIGH THEY MOVED HER TO ANOTHER HOSPITAL. THE CUSTOMER WAS TREATED BY INSULIN PUMP AND INJECTIONS. CUSTOMER WAS TREATED BY INTRAVENOUS INSULIN AND INJECTIONS AT THE HOSPITAL. CUSTOMER'S MOTHER STATED THAT LAST SUNDAY HER DAUGHTERS INSULIN PUMP STARTED TO ALARM INSULIN FLOW BLOCK. CUSTOMER TRIED CHANGING EVERYTHING, THE RESERVOIR AND INFUSION SET. CUSTOMER'S MOTHER MENTIONED THAT AFTER DOING AN INJECTION BLOOD GLUCOSE CAME DOWN A BIT SO CUSTOMER WENT BACK TO USING INSULIN PUMP AND BLOOD GLUCOSE WENT UP AGAIN. CUSTOMER WISHES TO CONTINUE TROUBLESHOOTING FOR INSULIN FLOW BLOCK ALARM. CUSTOMER STATES THEY HAD TRIED ALL REMEDIES. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO RETRIEVE AND SAVE INSULIN PUMP SETTINGS AND TO REVERT TO BACKUP PLAN PER HEALTHCARE PROFESSIONAL'S INSTRUCTIONS. INSULIN PUMP WILL NOT BE

  Patient problems: Hyperglycemia

  MAUDE report 9222693 ↗
• MalfunctionMar 14, 2019Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE INSULIN PUMP HAD AN AUDIO ANOMALY. THE DEVICE WAS NOT MAKING ANY SOUND WHEN ALARMING. THEY DID NOT HEAR BEEPS WHEN THE AUDIO VOLUME SETTINGS WERE SAVED. THE DEVICE DID NOT PASS TROUBLESHOOTING. THE CUSTOMER¿S BLOOD GLUCOSE DURING THE INCIDENT WAS 199 MG/DL AND 130 MG/DL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8423427 ↗
• MalfunctionFeb 12, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED CRITICAL PUMP ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 163 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP STARTED BEEPING THE NIGHT BEFORE AND PROMPTED WITH CRITICAL PUMP ERROR. TROUBLESHOOTING WAS PERFORMED AND DID NOT RESOLVE THE ISSUE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8333983 ↗
• MalfunctionFeb 11, 2019Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE INSULIN PUMP HAD AN AUDIO ANOMALY. THE DEVICE WAS NOT MAKING ANY SOUND WHEN ALARMING. TROUBLESHOOTING WAS NOT COMPLETED. THE CUSTOMER¿S BLOOD GLUCOSE DURING THE INCIDENT WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8328044 ↗
• MalfunctionJan 18, 2019Device Alarm System; Device Alarm System

  IT WAS REPORTED INSULIN PUMP HAD AN AUDIO ISSUE. CUSTOMER STATED THAT THE AUDIO ISSUE WAS CONFIRMED DURING THE CALL. THE DEVICE DID NOT PASS TROUBLESHOOTING. THE CUSTOMER¿S BLOOD GLUCOSE DURING THE INCIDENT WAS 76 MG/DL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8260061 ↗

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-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-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.