Recall archive / FDA device enforcement
MiniMed 640G Insulin Pump (O.U.S. Version) — FDA record Z-1354-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 23, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MiniMed 640G Insulin Pump (O.U.S. Version)
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Medtronic MiniMed
- Quantity
- 323,417 pumps
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1354-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 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NG1036629H NG1036630H N... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- 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
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 20, 2022
- Recall initiation date
- May 23, 2022
- Center classification date
- Jul 8, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.