Recall Z-0409-2026— Vantive US Healthcare LLC

Name: FDA recall Z-0409-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-28

Class II · Ongoing

Class II FDA medical device recall by Vantive US Healthcare LLC, initiated 2025-08-28. It names one FDA 510(k) clearance: K201867. 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). 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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy..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: Vantive US Healthcare LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-08-28
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K201867 — Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemBaxter Healthcare Corporation·cleared 2020-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

Data sourced from openFDA. This site is unofficial and independent of the FDA.