MiniMed630GRecalls & reported problems across all models

We found 2 models of MiniMed630G by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). Together they are named in 6,656 adverse event reports in the FDA's MAUDE database, received between May 17, 2018 and Jun 25, 2025 — classified as 17 deaths, 1,511 injuries, 5,128 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1,793 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MiniMed630G recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. 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-1740-2026 · Root cause: Device Design · Recall details · 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 · Recall details · FDA record ↗

4. 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 · names 2 of these models · Recall details · FDA record ↗

5. 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 · Recall details · FDA record ↗

Most reported MiniMed630G problems

MiniMed630G models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MiniMed®630G MMT-1715K

  Artificial pancreas device system, threshold suspend
  2 recalls17 deaths6,645 reports
• MiniMed®630G MMT-1755K

  Artificial pancreas device system, threshold suspend
  4 recalls11 reports

Recent MiniMed630G adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Battery Problem; Battery Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED RAPID BATTERY DEPLETION, WITH MULTIPLE "LOW BATTERY" AND "REPLACE BATTERY NOW" ALERTS OCCURRING LESS THAN 8 HOURS APART, DESPITE USING NEW ENERGIZER ALKALINE BATTERIES. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED THAT INCLUDED REVIEWING ALARM HISTORY AND VERIFYING BATTERY USAGE, 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 22325778 ↗
• MalfunctionJun 25, 2025Computer Software Problem; Battery Problem; Communication or Transmission Problem; Computer Software Problem; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED MULTIPLE ALARMS, INCLUDING PUMP ERROR 4 ALARM (THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM), PUMP ERROR 53 ALARM (SOFTWARE ERROR DETECTED) AND BATTERY FAILED ALARM, WITH THE BATTERY DEPLETING RAPIDLY (HALF DRAINED OVERNIGHT). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED, INCLUDING CLEARING ALARMS, INSPECTING THE BATTERY CAP AND COMPARTMENT FOR DAMAGE OR CORROSION, AND REVIEWING PUMP SETTINGS. THE CUSTOMER WAS ADVISED TO MONITOR THE PUMP AND CALL BACK IF 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 22325559 ↗
• MalfunctionMay 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER HAD DIFFERENT METER READINGS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED IN THE PRODUCT WAS MMT-1715K. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN IS REQUIRED FOR MMT-1715K.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307388 ↗
• InjuryJul 25, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 267 MG/DL AT THE TIME OF THE EVENT. CUSTOMER BELIEVES THAT THE PUMP WAS NOT GIVING ENOUGH INSULIN. THE CUSTOMER WAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTION AND THE CUSTOMER DOES NOT EXPERIENCED SYMPTOMS RELATED TO HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ALSO REPORTED HE EXPERIENCED A BLOOD GLUCOSE VALUE OF 433 MG/DL ON THE DAY OF HIGH BLOOD GLUCOSE EVENT REPORTED. THE CUSTOMER HAD USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE INSULIN PUMP HAS BEEN RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 17387064 ↗
• MalfunctionAug 2, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD CRACKED RETAINER RING AND THE RESERVOIR WAS ABLE LOCK IN PLACE. 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 15146250 ↗
• MalfunctionJul 28, 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 15119523 ↗
• MalfunctionJul 26, 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 CRACK BATTERY FROM TO BOTTOM AND RETAINER RING CAME OFF. 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 15101567 ↗
• MalfunctionJul 21, 2022Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT NO DELIVERY/OCCLUSION ALARM DURING THERAPY 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 15073908 ↗
• MalfunctionJul 20, 2022Obstruction of Flow; Date/Time-Related Software Problem; Moisture or Humidity Problem; Obstruction of Flow; Date/Time-Related Software Problem; Moisture or Humidity Problem

  MEDTRONIC RECEIVED INFORMATION THAT OCCLUDED, NO DELIVERY/OCCLUSION ALARM - UNKNOWN TIMING, TIME/CLOCK ANOMALY, EXPOSED TO MOISTURE 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 15063588 ↗
• 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 15063572 ↗
• MalfunctionJul 18, 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 15044543 ↗
• MalfunctionJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BLOOD GLUCOSE VALUE WAS 243 MG/DL. SG VALUE WAS 56 MG/DL. SG AND BG DIFFERENCE WAS 187 MG/DL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 15040657 ↗
• DeathJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOME ON (B)(6) 2020. THE CAUSE OF DEATH WAS ACUTE CORONARY/UNSTABLE ANGINA. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER RETURNED THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Angina

  MAUDE report 15039214 ↗
• MalfunctionJul 18, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BATTERY CAP CRACKED/DAMAGED OCCURRED. THERE WAS AN ALLEGATION OF BLOOD LOSS, RASH AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rash

  MAUDE report 15038772 ↗
• DeathJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOSPITAL ON (B)(6) 2019. THE CUSTOMER WAS HOSPITALIZED ON(B)(6) 2019. THE CALLER MENTIONED THAT THE CUSTOMER WAS ADMITTED FOR LOW HEMOGLOBIN. THE CAUSE OF DEATH WAS COMPLICATION FROM CHEMO THERAPY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER LAST WORN THE INSULIN PUMP ON (B)(6) 2019. THE INSULIN PUMP WILL BE RETURNED FOR PRODUCT ANALYSIS.

  Patient problems: Anemia

  MAUDE report 15038282 ↗

Other Medtronic Minimed, Inc. products

• MiniMed 670G23 models · 141,169 reports · 4 recalls
• MiniMed 630G23 models · 65,972 reports · 6 recalls
• Paradigm REAL-Time Revel180 models · 49,838 reports · 2 recalls
• MiniMed 530G71 models · 48,745 reports · 1 recall
• MiniMed670G2 models · 28,871 reports · 3 recalls
• MiniMed Reservoir6 models · 4,545 reports
• PARADIGM REAL-time95 models · 2,862 reports · 1 recall
• Guardian Sensor (3)11 models · 2,726 reports