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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/Home Healthcare

Sharesource Connectivity Platform Recalled for Therapy Delivery Software Defect

Agency Publication Date: October 29, 2025
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Summary

Vantive US Healthcare LLC is recalling approximately 1 unit of the Sharesource Connectivity Platform for Use with Homechoice Claria due to a critical software defect. The error affects software versions 7.13.3, 8.13.2, and 8.13.4 and can prevent updated therapy prescriptions from saving correctly to the dialysis machine used by the patient. This means a patient might receive an incorrect or outdated treatment while the clinician's remote screen incorrectly shows that the new prescription was successfully applied.

Risk

The software defect causes a mismatch between the treatment prescribed by a doctor and the treatment actually delivered by the device. If the dialysis cycler delivers incorrect therapy, the patient may not receive the necessary treatment for their condition, which could lead to serious health complications or ineffective dialysis.

What You Should Do

  1. This recall involves the Sharesource Connectivity Platform used with Homechoice Claria dialysis cyclers, specifically software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM) with UDI-DI 15413765545723.
  2. Stop using the recalled software versions for prescription management and updates.
  3. Contact your healthcare provider immediately to verify that the dialysis cycler you are using has the correct and current prescription settings.
  4. Contact Vantive US Healthcare LLC or your distributor to arrange for a software correction, update, or replacement instructions.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device software. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Sharesource Connectivity Platform for Use with Homechoice Claria
Variants: Software version 7.13.3 (China), Software version 8.13.2 (APAC and Korea), Software version 8.13.4 (US, EMEA, and LATAM)
Model / REF:
5CGM01
UDI:
15413765545723

Quantity affected: 1. This software platform is used to manage prescription settings for Homechoice Claria dialysis cyclers.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97527
Status: Active
Manufacturer: Vantive US Healthcare LLC
Sold By: Vantive US Healthcare LLC; Authorized medical device distributors; Hospitals and dialysis centers
Manufactured In: United States
Units Affected: 1
Distributed To: Nationwide

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.