Use caution Medical device recall · FDA · Published November 21, 2019

Medtronic MiniMed 630G System Recall: Loose Reservoir Risk

Medtronic recalls specific MiniMed 630G System models with SmartGuard due to potential loose reservoir causing insulin delivery issues. Affected units may lead to hypoglycemia or hyperglycemia.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0955-2020Medical device Medtronic ›

Use caution until it’s fixed

There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

Take action

Contact the company

Recalling firmMedtronic Inc.18000 Devonshire St · Northridge, CA 91325-1219

✎ GovInfoNow plain-language explainer

Medtronic is recalling certain MiniMed 630G System devices with SmartGuard because a loose reservoir can cause improper insulin delivery, risking low or high blood sugar levels. Read more at govinfonow.com/recall/66459-medtronic-minimed-630g-system-recall-loose-reservoir-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66459-medtronic-minimed-630g-system-recall-loose-reservoir-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0955-2020

Cite this page

“Medtronic MiniMed 630G System Recall: Loose Reservoir Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66459-medtronic-minimed-630g-system-recall-loose-reservoir-risk. Based on FDA recall #Z-0955-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0955-2020%22&limit=1).

The FDA announced on November 21, 2019, that Medtronic Inc. is recalling the Medtronic MiniMed 630G System with SmartGuard due to a loose reservoir hazard. The agency stated the issue could lead to over- or under-delivery of insulin.

How to tell if you have it

Brand: Medtronic
Product: Medtronic MiniMed 630G System with SmartGuard
Ref/Model #: MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755
Version: US and Canada Version Only
Serial Numbers: All Serial Numbers (excluding devices with black retainer rings)

The hazard

The FDA said there have been reported incidents of a loose reservoir that can no longer be locked into the pump. This condition results from a broken or missing retainer ring and could lead to over- or under-delivery of insulin, resulting in hypoglycemia or hyperglycemia.

Context

GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since September 10, 2017. Other recent recalls include the Medtronic Sphere-9 Catheter Recall (March 11, 2026), the Medtronic Abre Venous Stent Recall (December 4, 2025), and the Medtronic EVX 60 Series recall (October 29, 2025). Other recent recalls of similar products include the Medtronic MiniMed 630G Insulin Pump Recall (February 13, 2026) and the Medtronic MiniMed 640G and 780G Insulin Pump Recalls (July 13, 2026).

How to tell if you have this one

Check for the model numbers MMT-1515, MMT-1715, MMT-1714, MMT-1754, or MMT-1755 on the device. Devices with black retainer rings are not affected.

Brand
Medtronic
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
US:AK,AL,AR,AZ,BM,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: France, Germany, UK, Italy, Netherlands, Spain, Sweden, Israel, Norway, Austria, Belgium, Denmark, Czech Republic, Finland, Switzerland, Slovakia, Ireland, Poland, S. Africa, Greece, Hungary, Saudi Arabia, United Arab Emira, New Zealand, Australia, Japan, Mexico, Colombia, Brazil, S. East Asia, Korea, Canada,

Recall number	Product, codes & lots	Quantity
Z-0955-2020	Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only; All Serial Numbers ( excluding devices with black retainer rings)	—
Z-0956-2020	Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782; All Serial Numbers ( excluding devices with black retainer rings)	—
Z-0957-2020	Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 Not Distributed within the US; All Serial Numbers ( excluding devices with black retainer rings) NOT DISTRIBUTED WITHIN THE US*	—
Z-0958-2020	Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 Not for US Distribution; All Serial Numbers ( excluding devices with black retainer rings) NOT DISTRIBUTED WITHIN THE US*	—

Based on the official FDA remedy

What to do — step by step

Check Reservoir Lock
Ensure the reservoir is securely locked into the pump by pressing the side of the reservoir against the pump until it clicks. If it doesn't click, the reservoir may be loose.
Contact Medtronic
Reach out to Medtronic for guidance on whether your device needs repair or replacement.

Where it went and when

Where it was distributed

Distributed in 50 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “US:AK,AL,AR,AZ,BM,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: France, Germany, UK, Italy, Netherlands, Spain,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 3 months after the firm started it.

Nov 21, 2019Firm started the recall
Feb 7, 2020FDA classified it Class I
Feb 19, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66459-medtronic-minimed-630g-system-recall-loose-reservoir-risk">Medtronic MiniMed 630G System Recall: Loose Reservoir Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0955-2020 (November 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0955-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.