FDA recall, , Moderate risk
Paragonix Technologies KidneyVault Portable Renal Perfusion System
The KidneyVault Portable Renal Perfusion System may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Summary by Recall Canary from the FDA notice
What happened
Paragonix Technologies Inc., of Braintree, Massachusetts, is recalling its KidneyVault Portable Renal Perfusion System, REF# PRGNX-8008-001, 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. The recall affects 1445 systems and was initiated by the company on July 20, 2026, and added to the FDA's Enforcement Report on August 14, 2026.
The systems were distributed nationwide across the United States and territories, including states such as Alabama, Arizona, California, Tennessee, Florida, Hawaii, Minnesota, New Jersey, Texas, Utah, and others. The recall was classified by the FDA on August 14, 2026, and in the FDA's weekly enforcement report on August 26, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
- UDI-DI
- 00850005470342
- Lot code
- All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver
Recall details
- Company began the recall
- Sold in
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.
- Company
- Paragonix Technologies Inc.Braintree, Massachusetts
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99476
- Recall number
- Z-2967-2026
- Quantity recalled
- 1445 systems
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
