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Abbott Medical recalls Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Recalled July 10, 2024 · FDA recall Z-2265-2024 · Abbott Medical
Hazard
Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy. · FDA Class II
Units
302 units
Sold at
US: Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NE, NH, NJ, NY, OH OK, OR, PA, SC, SD, TX, UT, WI, WV.
Description
Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.
Product
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Manufacturer(s)
Abbott Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →