Sharesource Connectivity Platform for Use with Homechoice… recallZ-0409-2026 · Vantive US Healthcare LLC · initiated Aug 28, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vantive US Healthcare LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
FDA root cause category: Software design
What the company is doing
Clinics whose patients' programs were identified as being impacted by this issue were contacted by phone beginning 8/29/2025. Follow-up written notifications were sent out to all affected customers starting September 11, 2025. The Sharesource Claria software fix has been deployed and no further actions need to be taken by facilities who did not have directly affected patients. Note: If you have received the previous direct notification regarding a patient at your clinic, please note that Vantive will continue to be in touch with you regarding the next steps to correct those specific patient programs.
Recall details
- Recall number
- Z-0409-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 28, 2025
- Posted by the FDA
- Oct 29, 2025
- Recalling firm
- Vantive US Healthcare LLC
- Quantity
- 1
- Product code
- FKX
- FDA submissions
- K201867
- 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.
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)
Code information (models, lots, serial numbers)
UDI-DI 15413765545723 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sharesource 5CGM01Baxter Healthcare Corporation · System, peritoneal, automatic delivery1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K201867 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Homechoice Claria 5C6M40Baxter Healthcare Corporation · System, peritoneal, automatic delivery1 recall23 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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