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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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High RiskFDA Device
Medical Devices/Implants & Prosthetics

Abbott Medical: Liberta RC Deep Brain Stimulators Recalled for Unexpected Power Shut-Off

Agency Publication Date: July 3, 2024
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Summary

Abbott Medical is recalling 302 Liberta RC Implantable Pulse Generators because the deep brain stimulation system will unexpectedly turn off approximately every 50 days after activation. This recurring shutdown happens without warning and can lead to a complete loss of therapy for patients. These sterile, prescription-only devices are used for deep brain stimulation and were distributed across 32 U.S. states and the District of Columbia.

Risk

The device's internal programming causes it to shut down every 50 days, which stops the electrical stimulation to the brain and may cause a sudden return of symptoms or a medical emergency due to the loss of required therapy.

What You Should Do

  1. Identify if your device is affected by checking the serial number on your patient identification card or medical records against the list of recalled serial numbers, which includes codes such as 20196493, 20207397, 20219079, 20232812, 20237409, and 20240514 among 302 specific units.
  2. Check the model details on your device packaging or records for Abbott Liberta RC, Implantable Pulse Generator, REF: 62400 with UDI-DI 05415067047663.
  3. Contact your healthcare provider or neurosurgeon immediately to discuss the management of your stimulation therapy and to determine if your specific implanted device is subject to this recall.
  4. Contact Abbott Medical directly at their Plano, Texas facility or through your local Abbott representative to receive further technical instructions or information regarding a potential system update or remedy.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information and to report any adverse events.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction via notification letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Abbott Liberta RC, Implantable Pulse Generator
Model / REF:
REF: 62400
UPC Codes:
05415067047663
Lot Numbers (302):
20196493
20196495
20196496
20196497
20196498
20196500
20196502
20196503
20196504
20196505
20196506
20196507
20196508
20196509
20196511
20196512
20196513
20196514
20196515
20196516
20196517
20207397
20207398
20207399
20207400
20207401
20207402
20207403
20207404
20207406
20207407
20207408
20207409
20207410
20207411
20207412
20207413
20207416
20207417
20207419
20207420
20207421
20207422
20207423
20207424
20207425
20207427
20207428
20207429
20207430

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94747
Status: Active
Manufacturer: Abbott Medical
Sold By: Authorized Medical Distributors; Hospitals
Manufactured In: United States
Units Affected: 302 units
Distributed To: Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Wisconsin, West Virginia

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.

Find an Attorney

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.