medical MODERATE Updated 2026-08-26

Paragonix Technologies Inc. recalls Paragonix Technologies Inc. KidneyVault Portable Renal Perfu

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Recalled Product

Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001

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Hazard / Issue

Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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