MiniMed® 630G MMT-1755K (UDI 00643169752726)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00643169752726), received between May 31, 2017 and Aug 26, 2024 — classified as 6 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (12 reports).

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

7 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-0002-2025 · 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-0001-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. Sep 20, 2022Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 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 20063020 ↗
• MalfunctionJul 18, 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 15043192 ↗
• MalfunctionJul 18, 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 15041943 ↗
• MalfunctionJul 18, 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 15039607 ↗
• MalfunctionJul 18, 2022Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC), LEAKS, DAMAGE (CUSTOMER CAUSED) 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 15038727 ↗
• MalfunctionJul 18, 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 15038589 ↗
• MalfunctionJul 18, 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 15037981 ↗
• MalfunctionJul 14, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT FAILED BATTERY 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 15010565 ↗
• MalfunctionJul 3, 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 14902781 ↗
• MalfunctionJul 3, 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 14902597 ↗
• MalfunctionJun 28, 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 14847005 ↗
• MalfunctionOct 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S RETAINER RING WAS DAMAGED. CUSTOMER STATED THAT THE TOP PORTION OF THE RESERVOIR COMPARTMENT WAS BROKEN, CAME APART, WITH A MISSING PIECE. CUSTOMER ALSO STATED THAT RESERVOIR WAS ABLE TO LOCKED IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 10633425 ↗
• MalfunctionMay 1, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS CRACKED. CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED IN THE INSULIN PUMP. 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 10016566 ↗
• MalfunctionApr 29, 2020Circuit Failure; Communication or Transmission Problem; Circuit Failure; Communication or Transmission Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER PERFORMED THE SELF TEST AND THEY WERE NOT ABLE TO PASS THE TEST. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10008615 ↗
• MalfunctionApr 27, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS CRACKED. CUSTOMER STATED THAT THE RESERVOIR DID NOT LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 10001965 ↗
• MalfunctionApr 16, 2020Material Integrity Problem; Moisture or Humidity Problem; Power Problem; Material Integrity Problem; Moisture or Humidity Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR. CUSTOMER REPORTED THEY RECEIVED THE OPEN BOOK IMAGE ON THE INSULIN PUMP SCREEN. CUSTOMER STATED NO INSULIN PUMP ERROR DISPLAYED ON THE SCREEN BEFORE THE OPEN BOOK IMAGE. 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 9970732 ↗
• MalfunctionFeb 11, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP TOP OF THE RESERVOIR COMPARTMENT HAD DAMAGE AND CLEAR RING BROKE OFF. THE CUSTOMER STATED THAT THE RESERVOIR WAS UNABLE TO LOCK IN PLACE AND SOMETIMES CAME LOOSE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9691238 ↗
• MalfunctionJan 28, 2020Battery Problem; Power Problem; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT BATTERY DID NOT LAST MORE THAN 1 WEEK. CUSTOMER STATED THAT THE INSULIN PUMP HAD POWER LOSS 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 9635746 ↗
• MalfunctionDec 31, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVELS WERE 234 MG/DL, 254 MG/DL, 253 MG/DL, 350 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL BOLUS FOR HIGH BLOOD GLUCOSE. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. CUSTOMER STATED THEY HAD PROBLEM WITH THE CALIBRATION AND RECEIVED CALIBRATE NOW MESSAGE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9534631 ↗
• MalfunctionDec 30, 2019Moisture or Humidity Problem; Power Problem; Moisture or Humidity Problem; Power Problem

  IT WAS REPORTED THAT INSULIN PUMP HAD OPEN BOOK IMAGE ON THE PUMP SCREEN. THE BLOOD GLUCOSE LEVEL WAS 150 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THERE WAS NO ANY ALARM WAS DISPLAYED BEFORE THE OPEN BOOK IMAGE WAS DISPLAYED ON THE SCREEN. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9532007 ↗
• MalfunctionJan 31, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT INSULIN PUMP HAD CRITICAL PUMP ERROR ALARM. THE BLOOD GLUCOSE LEVEL WAS 163 MG/DL AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8294838 ↗
• MalfunctionOct 24, 2018Battery Problem; Battery Problem

  THE CUSTOMERS MOTHER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD A POWER ERROR DETECTED ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999254 ↗
• MalfunctionSep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A CRITICAL PUMP ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 382 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED. 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: Hyperglycemia

  MAUDE report 7892624 ↗
• MalfunctionAug 20, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INSULIN PUMP ALARMED CRITICAL PUMP ERROR. BLOOD GLUCOSE WAS UNKNOWN AT TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. TROUBLESHOOTING WAS COMPLETED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTION. THE CUSTOMER WILL RECEIVE A REPLACEMENT INSULIN PUMP AND WILL RETURN THE ONE THEY CURRENTLY USE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799642 ↗
• InjuryJun 12, 2018Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 61 MG/DL AT THE TIME OF THE INCIDENT THEN IT WAS 40 MG/DL, BLOOD GLUCOSE WAS 75 MG/DL, RECENT BLOOD GLUCOSE WAS 200 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR LOW BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH 3 BOTTLES OF GLUCOSE SYRUP. CUSTOMER WILL NOT RETURN DEVICE FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7594685 ↗

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-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.