MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage:…
Medical device recall Z-0517-2021. Published in FDA’s Enforcement Report on Dec 9, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 9, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 206 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Missing solder battery connection, which could interrupt power of insulin pump.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, fourteen years of age and older, requiring insulin.
206, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All serial numbers; expiration date- 3 years from date of manufacture. NG2094617H NG2094618H NG2094623H NG2094625H NG2094627H NG2094628H NG2094629H NG2094631H NG2094632H NG2094634H NG2094635H NG2094636H NG2094637H NG2094638H NG2094639H…
Every code shown here, 1,996 characters
All serial numbers; expiration date- 3 years from date of manufacture. NG2094617H NG2094618H NG2094623H NG2094625H NG2094627H NG2094628H NG2094629H NG2094631H NG2094632H NG2094634H NG2094635H NG2094636H NG2094637H NG2094638H NG2094639H NG2094640H NG2094641H NG2094642H NG2094644H NG2094645H NG2094646H NG2094647H NG2094648H NG2094649H NG2094650H NG2094651H NG2094652H NG2094653H NG2094654H NG2094655H NG2094656H NG2094657H NG2094658H NG2094659H NG2094660H NG2094661H NG2094662H NG2094663H NG2094664H NG2094668H NG2094669H NG2094670H NG2094695H NG2094696H NG2094697H NG2094698H NG2094699H NG2094700H NG2094702H NG2094704H NG2094705H NG2094707H NG2094711H NG2094712H NG2094714H NG2094718H NG2094719H NG2094724H NG2094726H NG2094728H NG2094730H NG2094732H NG2094733H NG2094735H NG2094737H NG2094739H NG2094740H NG2094743H NG2094767H NG2094769H NG2094771H NG2094772H NG2094773H NG2094774H NG2094775H NG2094776H NG2094777H NG2094779H NG2094781H NG2094783H NG2094789H NG2094795H NG2094799H NG2094800H NG2094801H NG2094803H NG2094805H NG2094806H NG2094807H NG2094809H NG2094820H NG2094822H NG2094824H NG2094825H NG2094826H NG2094827H NG2094828H NG2094829H NG2094830H NG2094832H NG2094834H NG2094836H NG2094846H NG2094847H NG2094849H NG2094851H NG2094853H NG2094855H NG2094856H NG2094858H NG2094860H NG2094862H NG2094863H NG2094864H NG2094865H NG2094866H NG2094875H NG2094877H NG2094879H NG2094881H NG2094883H NG2094884H NG2094886H NG2094890H NG2094892H NG2094903H NG2094905H NG2094906H NG2094908H NG2094910H NG2094912H NG2094914H NG2094916H NG2094919H NG2094921H NG2094923H NG2094925H NG2094926H NG2094929H NG2094930H NG2094931H NG2094932H NG2094933H NG2094934H NG2094936H NG2094937H NG2094939H NG2094941H NG2094945H NG2094947H NG2094950H NG2094964H NG2094966H NG2094968H NG2094972H NG2094975H NG2095028H NG2095034H NG2095036H NG2095038H NG2095039H NG2095046H NG2095048H NG2095050H NG2095052H NG2095054H NG2095056H NG2095058H NG2095060H NG2095065H NG2095067H NG2095069H NG2095071H NG2095073H NG2095075H…
FDA’s list runs to 2,336 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - U.S. Nationwide Distribution in the state of MD and the countries of Canada, Netherlands, Norway. ***Model 630G distributed in Canada and Model 670G distributed in US ***MODEL640G Distributed OUS ONLY*** OUS: Australia, Canada, Netherlands and Norway.
The states and territories these words name
- Maryland
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 30, 2020.
- FDA classified it on Dec 2, 2020.
- FDA’s Enforcement Report published it on Dec 9, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc., of Northridge, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,336 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.