Device recall

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

FDA recall source

Recall number

Z-2967-2026

Event id

99476

Status

Ongoing

FDA classification

Class II

Recalling firm

Paragonix Technologies Inc.

Report date

Aug 26, 2026

Initiated

Jul 20, 2026

Center classification date

Aug 14, 2026

Reason

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.

Quantity

1445 systems

Code info

All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2

Distribution

US Nationwide distribution in the states and territories of 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, UT, VA, WI, WV, IN, OH, KY, IL, MD, MN, OR.

Voluntary or mandated

Voluntary: Firm initiated

Location

Braintree, MA, United States