Cardius 2 XPODRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850816007034), received between Jun 30, 2025 and Jun 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Computer Software Problem; Computer Software Problem

  THE LOWER BACK OF THE LEFT LEG OF A PATIENT BECAME CAUGHT BETWEEN THE CHAIR AND FOOTREST AS THE CHAIR MOVED AUTONOMOUSLY TO A HOME POSITION. THE MOVEMENT OCCURRED AFTER THE OPERATOR PRESSED THE HOME BUTTON, AND THE CHAIR CONTINUED TO LOWER AUTOMATICALLY. THE OPERATOR, A NUCLEAR MEDICINE TECHNOLOGIST, WAS REPORTEDLY ENGAGED IN CONVERSATION AND DID NOT INSTRUCT THE PATIENT TO REPOSITION THEIR LEGS AS IS TYPICALLY DONE. THE PATIENT REPORTEDLY SUSTAINED HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 22354901 ↗