Vantive US Healthcare LLC: Device Recall

Recall #Z-0409-2026 · 08/28/2025

Class II: Risk

Recall Details

Recall Number
Z-0409-2026
Classification
Class II
Product Type
Device
Recalling Firm
Vantive US Healthcare LLC
Status
Ongoing
Date Initiated
08/28/2025
Location
Deerfield, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Reason for Recall

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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

Product Description

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)

Distribution Pattern

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.

Other Recalls by Vantive US Healthcare LLC

View all recalls by Vantive US Healthcare LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.