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Recall Observatory FDA recall evidence

Device product

MiniMed 740G Insulin Pump (O.U.S. Version)

Z-1357-2022

May 23, 2022

Class II

Product summary

Firm
Medtronic MiniMed
Event
Event 90370
Status
Ongoing
Classification
Class II
Quantity
40 pumps
Official record key
device-enforcement:Z-1357-2022

Official wording

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.

Code information: Product Number/CFN (O.U.S. Version) MiniMed" 740G pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) UDI Codes: Pending Serial Numbers (O.U.S.): NG2644996H NG2645006H NG2645007H NG2645013H NG2645014H NG2645023H NG2645025H NG2645026H NG2645030H NG2645032H NG2645051H NG2645062H NG2645065H NG2645066H NG2645067H NG2645074H NG2645077H NG2645081H NG2645086H NG2645097H NG2645100H NG2645101H NG2645115H NG2645116H NG2645117H NG2645119H NG2645120H NG2645122H NG2645125H NG2645127H NG2645128H NG2645139H NG2645143H NG2645146H NG2645148H NG2645150H NG2645151H NG2645164H NG2645178H NG2645213H

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.