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fda_recall · device_recall · high

Abbott Medical — Class II recall: Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

Event date
2025-11-19 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-0458-2026
Payload hash
a1c9eb84cd7214caad49c060…

Summary

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 Programme… Status: Ongoing.

Entities

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Frequently asked questions

Has Abbott Medical had other FDA enforcement actions?
Yes. Argus HQ has recorded 39 total FDA actions tied to Abbott Medical: 0 warning letters, 39 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2025-11-19; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2025). Abbott Medical — Class II recall: Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-medical-z-0458-2026
MLA
"Abbott Medical — Class II recall: Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-abbott-medical-z-0458-2026.
Chicago
Argus HQ Research. "Abbott Medical — Class II recall: Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-medical-z-0458-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_abbott_medical_z_0458_2026_2025,
  title = {Abbott Medical — Class II recall: Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-medical-z-0458-2026},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.

Abbott Medical — Class II recall: Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 · Argus HQ