MiniMed 640G Insulin Pump (O.U.S
Medical device recall Z-1354-2022. Published in FDA’s Enforcement Report on Jul 20, 2022.
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 Jul 20, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 53 states named in where it went
- 323,417 pumps 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?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MiniMed 640G Insulin Pump (O.U.S. Version)
323,417 pumps, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Number/CFN (O.U.S. Version) MiniMed 640G (MMT-1511, MMT-1512, MMT-1711, MMT-1712, MMT-1725 (Pre Prod only), MMT-1751, MMT-1752) UDI Codes: Pending Serial Numbers: NG1000091H NG1000104H NG1000140H NG1000173H NG1000184H NG1000213H…
Every code shown here, 1,997 characters
Product Number/CFN (O.U.S. Version) MiniMed 640G (MMT-1511, MMT-1512, MMT-1711, MMT-1712, MMT-1725 (Pre Prod only), MMT-1751, MMT-1752) UDI Codes: Pending Serial Numbers: NG1000091H NG1000104H NG1000140H NG1000173H NG1000184H NG1000213H NG1000236H NG1000317H NG1000323H NG1000353H NG1000386H NG1000408H NG1000418H NG1000426H NG1000447H NG1000489H NG1000509H NG1000514H NG1000525H NG1000526H NG1000527H NG1000539H NG1000549H NG1000554H NG1000602H NG1000612H NG1000645H NG1000654H NG1000803H NG1000804H NG1000810H NG1000821H NG1000836H NG1000939H NG1000949H NG1000976H NG1001057H NG1001165H NG1001179H NG1001224H NG1001251H NG1001283H NG1001310H NG1001406H NG1001530H NG1001554H NG1001604H NG1001635H NG1001736H NG1001779H NG1001818H NG1001832H NG1001844H NG1001918H NG1001942H NG1001952H NG1001971H NG1001973H NG1002098H NG1002102H NG1002114H NG1002141H NG1002166H NG1002167H NG1002172H NG1002177H NG1002234H NG1002240H NG1002269H NG1002306H NG1002353H NG1002354H NG1002365H NG1002423H NG1002450H NG1002514H NG1002530H NG1002551H NG1002654H NG1002680H NG1002737H NG1002857H NG1002859H NG1002980H NG1002985H NG1002993H NG1002997H NG1003005H NG1003012H NG1003015H NG1003070H NG1003095H NG1003102H NG1003129H NG1003133H NG1003185H NG1003190H NG1003206H NG1003242H NG1003266H NG1003267H NG1003270H NG1003291H NG1003319H NG1003342H NG1003359H NG1003360H NG1003365H NG1003379H NG1003387H NG1003418H NG1003458H NG1003465H NG1003469H NG1003482H NG1003499H NG1003503H NG1003515H NG1003528H NG1003541H NG1003556H NG1003560H NG1003586H NG1003587H NG1003665H NG1003677H NG1003695H NG1003706H NG1003744H NG1003787H NG1003811H NG1003814H NG1003818H NG1003822H NG1003835H NG1003839H NG1003861H NG1004494H NG1004511H NG1004559H NG1004570H NG1004582H NG1004632H NG1004732H NG1004839H NG1004851H NG1004853H NG1004890H NG1005024H NG1005038H NG1005046H NG1005062H NG1005272H NG1005332H NG1005383H NG1005443H NG1005446H NG1005453H NG1005455H NG1005488H NG1005537H NG1005542H NG1005548H NG1005570H NG1005577H NG1005583H…
FDA’s list runs to 3,557,767 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.
U.S.: AK, AL, AR, AZ, 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, VI, VT, WA, WI, WV, and WY O.U.S.: Not provided
The states and territories these words name
53 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- US Virgin Islands
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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?
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 May 23, 2022.
- FDA classified it on Jul 8, 2022.
- FDA’s Enforcement Report published it on Jul 20, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic MiniMed, 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 3,557,767 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.