FDA-Device2025-11-19Class IIPROCESSING DEFECT
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
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).
Who it affects
Adults
Illnesses reported
None reported
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-0458-2026More Abbott recalls
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