FDA recall Z-2265-2024

Abbott Medical · Class II · device

Product

Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY

Reason for recall

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2024-05-16
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plano, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2265-2024