Medical device recalls Moderate risk

Medtronic MiniMed, Inc. recalls MiniMed insulin pump, REF: 620G (MMT-1750)

Recall date
January 31, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1258-2025
FDA classification
Class II
Brand / firm
Medtronic MiniMed, Inc.
Sold / distributed
Worldwide - US Nationwide distribution including in the states of 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, WY and the countries of A…

Why it was recalled

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

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 insulin pump, REF: 620G (MMT-1750)

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