MiniMed® 630G MMT-1715KMRecalls & reported problems

Summary

The FDA's MAUDE database contains 9,892 adverse event reports that list this exact device (DI 00643169873834), received between May 4, 2017 and Jun 25, 2025 — classified as 50 deaths, 3,328 injuries, 6,514 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1,901 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

2. Sep 20, 2022Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 9,892 reports, 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 A LOW BATTERY LIFE OF THE INSULIN PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1715KM. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DISCONTINUED USE OF THE INSULIN PUMP. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325332 ↗
• InjuryMay 24, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER HAD EXPERIENCED HYPOGLYCEMIA AND THE BLOOD GLUCOSE DELIVERY WAS UNDATABLE. THE BLOOD GLUCOSE AT THE TIME OF THE EVENT WAS 76 MG/DL. THE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS HOSPITALIZED FOR OTHER ISSUES AND THERE WAS NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 19392330 ↗
• MalfunctionJul 14, 2023Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED CLIP DOES NOT STAY ON THE PUMP. TROUBLESHOOTING WAS PERFORMED AND FOUND DAMAGE ON THE GROOVE AT THE BACK OF THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323821 ↗
• MalfunctionJan 31, 2023Circuit Failure; Mechanical Problem; Circuit Failure; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER REPORTED PUMP ERROR-43 AND PUMP ERROR-63. NO HARM RECURRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER ABLE TO CLEAR THE ALARM AND REWIND TEST. INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269894 ↗
• MalfunctionAug 26, 2022Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD PRIME FILL ANOMALY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. INSULIN PUMP WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15301518 ↗
• MalfunctionAug 11, 2022Battery Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A LOW BATTERY ALERT. CUSTOMER STATED THAT BATTERY DID NOT LAST MORE THAN 1 WEEK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15207859 ↗
• MalfunctionAug 5, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS DAMAGED. THE LOCATION OF DAMAGE WAS THE RESERVOIR RING. THE TYPE OF DAMAGE WAS BROKEN PIECES. 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 15172927 ↗
• MalfunctionAug 4, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RETAINER RING WAS CHIPPED OFF. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15162253 ↗
• MalfunctionAug 4, 2022Wireless Communication Problem; Wireless Communication Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER HAD LOW BLOOD GLUCOSE AND WAS HOSPITALIZED FOR CIRRHOSIS. CUSTOMER TOOK OUT BATTERY FROM THE INSULIN PUMP BUT IT DID NOT GET BLOOD GLUCOSE FROM GLUCOMETER. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 15162224 ↗
• MalfunctionAug 2, 2022No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  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 15146343 ↗
• MalfunctionAug 2, 2022Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A CRACKED RETAINER RING AND BELT CLIP RAILS. CUSTOMER REPORTED THAT THE DAMAGE OCCURRED DUE TO NORMAL WEAR AND TEAR. CUSTOMER REPORTED THAT THE RESERVOIR WAS ABLE TO LOCK INTO PLACE WHEN INSERTED INTO INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146262 ↗
• MalfunctionJul 28, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Hypoglycemia

  MAUDE report 15120808 ↗
• MalfunctionJul 26, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction 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 15101702 ↗
• MalfunctionJul 25, 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 15093322 ↗
• MalfunctionJul 25, 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 15092692 ↗
• MalfunctionJul 25, 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 15092184 ↗
• MalfunctionJul 25, 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 15090982 ↗
• MalfunctionJul 22, 2022Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RETAINER RING WAS MISSING. THE CUSTOMER ALSO STATED THAT THE LIP RING WAS DAMAGED AND THE RESERVOIR SIDE WAS CRACKED. THE CUSTOMER STATED THAT THE RESERVOIR DID LOCK IN PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15083468 ↗
• MalfunctionJul 22, 2022Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD CRACKED RETAINER RING AND THE RESERVOIR WAS ABLE TO LOCK IN PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOT WAS PERFORMED AND THE CUSTOMER WILL DISCONTINUE USE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081656 ↗
• MalfunctionJul 21, 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 15074284 ↗
• MalfunctionJul 21, 2022Patient Device Interaction Problem; Patient Device Interaction 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 15071428 ↗
• MalfunctionJul 20, 2022Break; Battery Problem; No Apparent Adverse Event; Break; Battery Problem; No Apparent Adverse Event

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED REPLACE BATTERY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064744 ↗
• MalfunctionJul 20, 2022Break; Obstruction of Flow; No Apparent Adverse Event; Patient Device Interaction Problem; Break; Obstruction of Flow; No Apparent Adverse Event; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR LIP RING OF INSULIN PUMP WAS DAMAGED. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE. IT WAS STATED THAT TWO PIECES OF PLASTIC CHIPPED OUT AND THE INSULIN PUMP ALARMED INSULIN FLOW BLOCKED BUT THE ISSUE WAS RESOLVED WITH COMPLETE SET CHANGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15063394 ↗
• MalfunctionJul 19, 2022Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR LIP RING OF INSULIN PUMP AND RESERVOIR COMPARTMENT WAS DAMAGED. THE CUSTOMER STATED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE. IT WAS STATED THAT THE RESERVOIR WAS STUCK IN PUMP, CLIP WAS BROKEN OFF AND THE PUMP WAS DROPPED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15049651 ↗
• MalfunctionJul 18, 2022Communication or Transmission Problem; Loss of Data

  MEDTRONIC RECEIVED INFORMATION THAT PUMP ERROR 15, PUMP ERROR 4 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 15044796 ↗

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-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-18
• 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.