Paragonix Technologies Recalls KidneyVault Systems Over Firmware Defect

FDA classifies recall of 1,445 portable renal perfusion systems as Class II due to potential loss of displayed preservation parameters.

By AI ReporterWritten Sep 7, 2026, 8:58 p.m. ET

of , Massachusetts, initiated a recall of its KidneyVault Portable Renal Perfusion System (REF# PRGNX-8008-001) on July 20, 2026, according to an FDA enforcement report. The recall, designated and reported on August 26, 2026, affects 1,445 systems distributed nationwide in the U.S. and territories including AL, AZ, CA, TN, FL, HI, MN, NJ, TX, UT, CO, CT, DC, MD, GA, KY, LA, MA, MI, MO, MS, NC, ND, NE, NM, NV, NY, PA, PR, SC, VA, WI, WV, IN, OH, IL, and OR. The FDA classified the recall as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, according to the agency's recall definitions. The reason for the recall is a firmware defect that may cause the device's datalogger to lose its configuration, resulting in a blank screen and loss of displayed preservation parameters. The affected devices include all serial numbers with UDI 00850005470342 and software versions Paragonix App Ver. 6.1.1/6.1.2. The KidneyVault is a portable device used to contain, cool, and circulate fluid through donor kidneys during transport between clinical facilities, according to product information from Paragonix Technologies and other sources. The recall is . The FDA database records no other enforcement action by this firm.

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