MiniMed® 630G MMT-1715KL (UDI 00763000367053)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00763000367053), received between Jul 17, 2020 and Jun 24, 2022 — classified as 15 injuries, 15 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (8 reports).

3 FDA recall records name this device's identifier, 3 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 ↗

3. 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2022No Display/Image; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT BATTERY CAP CRACKED/DAMAGED, BLANK DISPLAY 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 14797207 ↗
• MalfunctionMay 6, 2022Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS IDENTIFIED THAT THE CUSTOMER¿S BASAL PROGRAMMING WAS UNKNOWN. CUSTOMER WAS HIGH UP TO 300 MG/DL. THERE WAS NO BASAL PROGRAMMED ON THE INSULIN PUMP. CUSTOMER HAD BEEN USING INSULIN PUMP WITHIN 48 HOURS OF HIGH BLOOD GLUCOSE EVENT. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 14312374 ↗
• MalfunctionAug 31, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR LIP RING WAS BROKEN. THE RESERVOIR WAS ABLE TO LOCK IN PLACE. 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 10470887 ↗
• MalfunctionAug 13, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THE RECEIVED REPLACEMENT INSULIN PUMP AND DISPLAY WAS BLANK AFTER INSTALLING NEW BATTERY THE ISSUE WAS NOT RESOLVED. THE CUSTOMER DECLINED TROUBLESHOOTING. 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 10400549 ↗
• MalfunctionAug 12, 2020Mechanical Jam; Mechanical Jam

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR ALARM AND NOT ABLE TO COMPLETE REWIND. 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 10394688 ↗
• InjuryAug 11, 2020Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 600 MG/DL. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS PAIN. CUSTOMER STATED INSULIN PUMP DID NOT GIVE WARNING AND BLOOD GLUCOSE WERE HIGH. INFUSION SET HAD BENT CANNULA. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Pain

  MAUDE report 10390139 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 495 MG/DL, 396 MG/DL AT THE TIME OF INCIDENT. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT AND AUTO MODE WAS INACTIVE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10389342 ↗
• InjuryAug 10, 2020Adverse 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 THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 600 MG/DL. CURRENT BLOOD GLUCOSE LEVEL WAS 620 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL AND WANTED TO GO TO THE BOLUS WIZARD TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10383587 ↗
• MalfunctionAug 10, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. DISPLAY DID NOT RETURN AFTER INSULIN PUMP RESTART. 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 10383561 ↗
• InjuryAug 7, 2020No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER¿S BLOOD GLUCOSE LEVELS WAS 48 MG/DL. THEY TREATED BY EATING YOGURT. THE CUSTOMER REPORTED THAT THEY TRIED TO TURN ON REPLACEMENT INSULIN PUMP BY INSERTING A NEW BATTERY BUT IT DID NOT TURN ON. THE CUSTOMER PLACED THE BATTERY CAP CORRECTLY AND THE INSULIN PUMP TURNED ON. THE CUSTOMER DECLINED LOW BLOOD GLUCOSE LEVEL TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10379281 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE AND ALSO EXPERIENCED DIABETIC KETOACIDOSIS. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 122 MG/DL AND LOW BLOOD GLUCOSE WAS 59 MG/DL. THE CUSTOMER TREATED LOW BLOOD GLUCOSE WITH FOOD. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Hypoglycemia

  MAUDE report 10378118 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 600 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10377773 ↗
• InjuryAug 6, 2020Adverse 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 THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REFUSE TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10372579 ↗
• InjuryAug 6, 2020Adverse 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 THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 452 MG/DL AND 395 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT AUTO MODE FEATURE WAS NOT ACTIVE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10371815 ↗
• MalfunctionAug 5, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD STUCK BUTTON ALARM. THE INSULIN PUMP HAD KEYPAD ANOMALY. 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 10366741 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 518 MG/DL AND 413 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10366690 ↗
• MalfunctionAug 5, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER WAS ALSO REPORTED THAT BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED, BATTERY CAP WAS NEITHER MISSING NOR DAMAGED, AND THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER WAS REPORTED THAT THE INSULIN PUMP DISPLAY DID NOT RETURN AFTER RESTART. 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 10366274 ↗
• InjuryAug 4, 2020Adverse 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 THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS TREATED WITH MANUAL INJECTION OR INSULIN PEN. CUSTOMER WAS NOT USING AUTO MODE FEATURE. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10360972 ↗
• MalfunctionAug 4, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. CUSTOMER STATED THAT THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. CUSTOMER STATED THAT THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED. CUSTOMER STATED THAT THE BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED ALSO THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE DISPLAY DID NOT RETURN AFTER INSULIN PUMP RESTART. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10360533 ↗
• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 580 MG/DL, 485 MG/DL. CUSTOMER WAS TREATED WITH SHOT. CUSTOMER DID NOT FELL OK TO TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10348846 ↗
• MalfunctionJul 31, 2020Visual Prompts will not Clear; Moisture or Humidity Problem; Power Problem; Visual Prompts will not Clear; Moisture or Humidity Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR ALARM. THE CUSTOMER STATED THEY WERE SWIMMING AT THE TIME OF EVENT. 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 10348642 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY REACHED OUT TO EMERGENCY MEDICAL SERVICES DUE TO HYPOGLYCEMIA ON UNKNOWN DATE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 78 MG/DL AT TIME OF INCIDENT. THE CUSTOMER WAS TREATED WITH INTRAVENOUS DRIP AND GLUCAGON SHOT. CUSTOMER WAS NOT RESPONDING AS QUICKLY AND THEIR VOICE STUTTER ALREADY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10343162 ↗
• MalfunctionJul 30, 2020No Display/Image; Display or Visual Feedback Problem; Visual Prompts will not Clear; No Display/Image; Display or Visual Feedback Problem; Visual Prompts will not Clear

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP DID NOT TURN ON AND ALSO HAD FROZEN DISPLAY. CUSTOMER STATED INSULIN PUMP HAD FLASHING SCREEN AND NO REPORT OF INSULIN PUMP SCREEN FLASHING WHEN SCREEN WAS TURNED ON AFTER BEING IN SLEEP MODE. TROUBLESHOOTING WAS PERFORMED. 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 10343059 ↗
• MalfunctionJul 29, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN FLOW BLOCK ALARM. CUSTOMER HAD TRIED ALL RECOMMENDED TROUBLESHOOTING. 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 10336750 ↗
• InjuryJul 26, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA AND RECEIVED INSULIN FLOW BLOCK ALARM AND IT WAS RESOLVED BY RESERVOIR CHANGE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL, 199 MG/DL AND 476 MG/DL. CUSTOMER DID THE INJECTION AND TRIED TO DO BOLUS BUT THE BLOOD GLUCOSE KEPT RAISING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10324553 ↗

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-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.