FDA Medical Device Recalls (openFDA)
Vantive US Healthcare LLC: 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)
- Recall number
- Z-0409-2026
- Recalling firm
- Vantive US Healthcare LLC
- 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)
- Status
- Open, Classified
- Initiated
- 2025-08-28
- Posted
- 2025-10-29
- Terminated
- not on file
- 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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 1
- 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.
- Lot, serial or model codes
- UDI-DI 15413765545723 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
- 510(k) numbers
- ["K201867"]
- PMA numbers
- not on file
- Product code
- FKX
- Firm FEI
- 3030306055
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28