MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL
Medical device recall Z-0438-2016. Published in FDA’s Enforcement Report on Dec 23, 2015.
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 23, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 1052 units 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?
The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is either lack of greasing or deficient greasing in a ball bearing assembly of the motor.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.
1052 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
NG1000742H NG1001185H NG1001199H NG1001204H NG1001206H NG1002461H NG1006813H NG1007995H NG1013701H NG1015570H NG1016916H NG1017305H NG1019509H NG1019517H NG1019519H NG1019521H NG1019522H NG1019523H NG1019528H NG1019530H NG1019533H…
Every code shown here, 1,991 characters
NG1000742H NG1001185H NG1001199H NG1001204H NG1001206H NG1002461H NG1006813H NG1007995H NG1013701H NG1015570H NG1016916H NG1017305H NG1019509H NG1019517H NG1019519H NG1019521H NG1019522H NG1019523H NG1019528H NG1019530H NG1019533H NG1019534H NG1019536H NG1019543H NG1019544H NG1019547H NG1019549H NG1019550H NG1019551H NG1019553H NG1019555H NG1019556H NG1019557H NG1019558H NG1019559H NG1019561H NG1019562H NG1019564H NG1019565H NG1019566H NG1019567H NG1019568H NG1019569H NG1019571H NG1019572H NG1019573H NG1019576H NG1019577H NG1019578H NG1019579H NG1019580H NG1019581H NG1019583H NG1019585H NG1019586H NG1019587H NG1019588H NG1019589H NG1019590H NG1019591H NG1019595H NG1019596H NG1019597H NG1019598H NG1019600H NG1019601H NG1019602H NG1019603H NG1019604H NG1019606H NG1019607H NG1019608H NG1019609H NG1019610H NG1019611H NG1019612H NG1019613H NG1019615H NG1019616H NG1019617H NG1019618H NG1019619H NG1019620H NG1019621H NG1019622H NG1019623H NG1019624H NG1019625H NG1019626H NG1019627H NG1019628H NG1019630H NG1019631H NG1019632H NG1019633H NG1019634H NG1019635H NG1019636H NG1019637H NG1019638H NG1019640H NG1019641H NG1019642H NG1019644H NG1019646H NG1019647H NG1019649H NG1019650H NG1019651H NG1019652H NG1019654H NG1019655H NG1019656H NG1019657H NG1019658H NG1019659H NG1019663H NG1019664H NG1019666H NG1019667H NG1019669H NG1019670H NG1019671H NG1019672H NG1019673H NG1019674H NG1019676H NG1019677H NG1019678H NG1019679H NG1019680H NG1019681H NG1019682H NG1019683H NG1019684H NG1019686H NG1019688H NG1019689H NG1019691H NG1019692H NG1019693H NG1019695H NG1019696H NG1019697H NG1019698H NG1019699H NG1019701H NG1019702H NG1019703H NG1019704H NG1019705H NG1019706H NG1019707H NG1019708H NG1019709H NG1019710H NG1019713H NG1019714H NG1019715H NG1019716H NG1019717H NG1019718H NG1019720H NG1019721H NG1019722H NG1019723H NG1019725H NG1019726H NG1019727H NG1019730H NG1019731H NG1019732H NG1019733H NG1019734H NG1019735H NG1019736H NG1019737H NG1019739H NG1019740H NG1019741H NG1019743H…
FDA’s list runs to 11,571 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.
Internationally Distribution only to the countries of : Australia, Austria, Belgium, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Italy, Japan, Kenya, Luxembourg, Namibia, Netherlands, Norway, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Sep 25, 2015.
- FDA classified it on Dec 17, 2015.
- FDA’s Enforcement Report published it on Dec 23, 2015.
- FDA terminated it on Feb 5, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic MiniMed 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 11,571 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
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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.