KidneyVault Portable Renal Perfusion System
Paragonix recalls KidneyVault perfusion system over firmware defect causing blank screen.
Contact Paragonix Technologies Inc. for instructions on updating the firmware to prevent loss of preservation parameters.
Recall at a glance
- Quantity recalled
- 1445 systems
Why it was recalled
Paragonix Technologies is recalling the KidneyVault Portable Renal Perfusion System due to a firmware defect that may cause the datalogger to lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
- Lot code
- All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver
- UDI-DI
- 00850005470342
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Software Defect recalls
Editorial summary by Recall Canary · summary updated 2026-08-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification