# FDA recall Z-0409-2026

> **Vantive US Healthcare LLC** · Class II · device recall initiated 2025-08-28.

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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

## 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.

## Key facts

- **Recall number:** Z-0409-2026
- **Recalling firm:** Vantive US Healthcare LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-28
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0409-2026

## Citation

> AI Analytics. FDA recall Z-0409-2026. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0409-2026. Source: US FDA. Licensed CC0.

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