The Recall Desk
HighFDA (Devices)·Z-0409-2026·Announced 2025-11-05

[pending] Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software ve

Pending LLM rewrite. Source: FDA_DEVICE Z-0409-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

The recalled product

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)
Manufacturer
Vantive US Healthcare LLC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • UDI-DI 15413765545723 software versions 7.13.3 (China)
  • 8.13.2 (APAC and Korea)
  • and 8.13.4 (US
  • EMEA
  • and LATAM)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category