FDA-Device2025-11-19Class II
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Abbott Medical
Hazard
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
Sold states
Worldwide distribution.
Affected count
20715 units
Manufactured in
6901 Preston Rd, Plano, TX, United States
Products
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2026Don't want to check this manually?
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