MiniMed® 630G MMT-1715KL (UDI 00763000256807)Recalls & reported problems

Medtronic Minimed, Inc. · PUMP MMT-1715KL 630G V4.11 JBL MG · Class 3

All models of MiniMed 630G (23)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Medtronic MiniMed 630G insulin pump has 191 reports, 52 injuries and no deaths. Some reports describe cracked or loose parts such as the reservoir retainer ring, blank displays, and power problems. It has 3 open recalls: insulin delivery can change when the pump is raised or lowered relative to the infusion site, battery life can be reduced after the pump is dropped or bumped, and a deteriorating battery cap can cause loss of power.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 191
Deaths reported: 0
Injuries reported: 52
Recalls naming it: 3

Summary

The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 00763000256807), received between Sep 17, 2019 and Aug 4, 2022 — classified as 52 injuries, 139 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (50 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

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 ↗
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 ↗
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

Device problems

Patient Device Interaction Problem50
Adverse Event Without Identified Device or Use Problem46
No Apparent Adverse Event30
No Display/Image30
Power Problem30
Obstruction of Flow15
Mechanical Problem13
Break11

Patient problems

No Consequences Or Impact To Patient108
Hyperglycemia48
No Clinical Signs, Symptoms or Conditions21
Hypoglycemia14
No Known Impact Or Consequence To Patient2
Seizures2
Cardiac Arrest1
Complaint, Ill-Defined1

Recent adverse event reports

The 25 most recent of 191 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 4, 2022Break; Break
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS CAME OFF. THE RESERVOIR WAS ABLE TO LOCK IN THE PLACE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NEITHER BEEN BUMPED NOR DROPPED. 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 15162445 ↗
MalfunctionAug 2, 2022Break; Break
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS CRACKED. THE RESERVOIR WAS ABLE TO LOCK IN THE PLACE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NEITHER BEEN BUMPED NOR DROPPED. 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 15150086 ↗
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 14906980 ↗
MalfunctionJul 4, 2022No Display/Image
MEDTRONIC RECEIVED INFORMATION THAT 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 14906112 ↗
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 14905809 ↗
MalfunctionJul 4, 2022Obstruction 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 14904115 ↗
MalfunctionJun 29, 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 14850676 ↗
MalfunctionJun 26, 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 14822946 ↗
MalfunctionJun 25, 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 14814225 ↗
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 14797156 ↗
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 14796975 ↗
MalfunctionJun 24, 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 14796875 ↗
MalfunctionJun 23, 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 14785102 ↗
MalfunctionJun 22, 2022Break; Device Markings/Labelling Problem
MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC), LABELING ANOMALY 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 14783702 ↗
MalfunctionJun 21, 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 14759947 ↗
MalfunctionJun 21, 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 14757142 ↗
MalfunctionJun 21, 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 14751989 ↗
MalfunctionJun 19, 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 14740436 ↗
MalfunctionJun 9, 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 14649309 ↗
MalfunctionJun 9, 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 14649192 ↗
MalfunctionJun 3, 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 14594683 ↗
MalfunctionSep 3, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR RETAINER RING WAS CRACKED AND MISSING HOWEVER 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 10487660 ↗
MalfunctionSep 3, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BATTERY COMPARTMENT OF INSULIN PUMP WAS CRACKED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10486964 ↗
MalfunctionAug 19, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BATTERY COMPARTMENT AND THE LIP RING WAS CRACKED HOWEVER THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO 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 10424429 ↗
MalfunctionAug 13, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR RING CAME OFF. THE CUSTOMER STATED THAT THE RESERVOIR DID NOT LOCK INTO 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 10400793 ↗

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-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.

Device details

UDI-DI	`00763000256807`
Brand	MiniMed® 630G
Model	MMT-1715KL
Company	Medtronic Minimed, Inc.
Product code	OZO · Automated insulin dosing , threshold suspend
Class	Class 3
FDA submission	P150001
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Aug 9, 2023

Device type (GMDN): Ambulatory insulin infusion pump, electronic, software-dosing, binary algorithm

A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on pre-set thresholds using a dichotomous or binary algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.

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All Automated insulin dosing , threshold suspend devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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