Company: Vantive US Healthcare LLC
Date of Enforcement Report: 10/29/2025
Class: II

PRODUCT

Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)

Recall Number:

Z-0409-2026

REASON:

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician’s remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

RECALLING FIRM/MANUFACTURER:

Vantive US Healthcare LLC

VOLUME:

1

DISTRIBUTION:

Worldwide distribution – US Nationwide and the countries of Australia, Hong Kong, Korea, New Zealand, Taiwan, Thailand, France, Germany, Ireland, Netherlands, Italy, Spain, Turkey, United Kingdom, Chile, and Colombia.