Medtronic MiniMed recalls MiniMed 640G Insulin Pump (O.U.S. Version)

Recall date

May 23, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1354-2022

FDA classification

Class II

Brand / firm

Medtronic MiniMed

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MiniMed 640G Insulin Pump (O.U.S. Version)