KidneyVault PRGNX-8008-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850005470335), received between Aug 14, 2025 and Mar 16, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 20, 2026Class IIOpen, Classified

   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.

   Z-2967-2026 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026

  AT THE TIME OF THE PATIENT'S RENAL TRANSPLANT, UPON REMOVING THE CANNISTER ASSEMBLY FROM THE SHIPPING HOUSING, IT WAS DISCOVERED THAT A PORTION OF THE PRESERVATION SOLUTION HAD LEAKED FROM THE CANISTER ASSEMBLY TO THE SHIPPER ASSEMBLY. UPON FURTHER INSPECTION, A TEAR IN THE CLOSED-CIRCUIT TUBING WAS IDENTIFIED APPROXIMATELY AT THE POINT IN WHICH THE TUBING CAME INTO CONTACT WITH THE PERISTALTIC PUMP / CLASPING. THE PATIENT WAS INFORMED OF THE FINDINGS; RISKS/BENEFITS WERE DISCUSSED AND THEY ELECTED TO PROCEED WITH TRANSPLANTATION. THEY HAVE SINCE RECOVERED WITHOUT ANY IDENTIFIED ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619168 ↗
• MalfunctionAug 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AT APPROXIMATELY 05:58 ON (B)(6) 2025 UPON INITIAL INSPECTION AT THE RECIPIENT TRANSPLANT CENTER, IT WAS NOTICED THAT THE FRONT OF THE DEVICE WAS WET AND APPEARED TO BE ACTIVELY LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804829 ↗