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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Abbott Medical: 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).

Agency Publication Date: November 7, 2025
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Summary

Abbott Medical has recalled approximately 20,715 units of the Eterna Spinal Cord Stimulation (SCS) IPG (Model 32400) and Liberta RC Deep Brain Stimulation (DBS) IPG (Model 62400). These implanted medical devices may experience a technical failure resulting in a loss of communication with Clinician Programmers or Patient Controllers. This communication gap can prevent necessary adjustments to the device therapy or monitoring.

Risk

A loss of communication between the implanted generator and the external controller prevents clinicians and patients from adjusting stimulation settings or checking device status, which could lead to a loss of therapy or the inability to turn the device off if needed. While no specific injuries are listed in this brief, the medium risk level reflects the potential for clinical complications if the implanted pulse generator cannot be managed externally.

What You Should Do

  1. Identify if your implant is affected by checking the Model Number (32400 or 62400) and your specific Serial Number against the provided list in your patient records.
  2. If you experience a loss of communication with your Patient Controller (PC) or if your Clinician Programmer (CP) cannot connect to the device, contact your healthcare provider immediately.
  3. Do not attempt to troubleshoot the device hardware yourself; follow the specific guidance provided by Abbott Medical or your implanting physician.
  4. For additional information or to verify your serial number, contact Abbott Medical at their Plano, TX facility or call the FDA device monitoring hotline.

Your Remedy Options

๐Ÿ“‹Other Action

Notification and ongoing clinical monitoring

How to: Contact the manufacturer or physician to determine if the implanted device is among the affected serial numbers and follow clinical guidance for potential communication loss.

Affected Products

Product: Eterna SCS IPG (Implantable Pulse Generator)
Model / REF:
32400
UPC Codes:
05415067040763
Lot Numbers (271):
19400015
19400017
19400020
19400021
19400022
19400023
19400025
19400026
19400029
19400030
19400031
19400033
19400035
19400037
19400038
19400039
19400040
19400041
19400042
19400043
19400044
19400045
19400048
19400051
19473833
19473834
19473835
19473836
19473837
19473838
19473839
19473840
19473841
19473842
19473843
19473845
19473850
19473851
19473852
19473853
19473854
19473855
19473857
19473859
19473861
19473862
19473866
19473867
19473870
19475756
Product: Liberta RC DBS IPG (Deep Brain Stimulation)
Model / REF:
62400

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97754
Status: Active
Manufacturer: Abbott Medical
Manufactured In: United States
Units Affected: 2 products (20715 units; 722 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.