FDA-Device2022-07-20Class II

MiniMed 630G Insulin Pump (U.S. and Canada Version)

Medtronic MiniMed
Hazard

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.

Sold states
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
Affected count
126,558 pumps
Manufactured in
18000 Devonshire St, Northridge, CA, United States
Products
MiniMed 630G Insulin Pump (U.S. and Canada Version)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1353-2022

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