NA BIOD134401Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551006231), received between May 29, 2025 and May 29, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination 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.

• MalfunctionMay 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED CABLE INTERFACE CARTO 3 SYSTEM SPLIT HANDLE AND DURING PRE-OP, THE HANDLE OF THE CABLE WAS DIRTY WHICH WAS SEEN THROUGH THE STERILE PACKAGING. THE SUBSTANCE LOOKS LIKE BETADINE. THE PRIMARY PLASTIC PACKAGING WAS NOT OPENED, SINCE THE DEVICE DID NOT LOOK CLEAN. THERE WAS NO PHYSICAL DAMAGE TO THE PACKAGE OBSERVED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22108387 ↗