NA BIOBD710FJ282RTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551005951), received between Aug 3, 2023 and Feb 29, 2024 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionFeb 29, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE WITH A REPROCESSED EP DIAGNOSTIC CATHETER AND WHEN THE CATHETER WAS OPENED THERE WERE SOME FUZZ ON PART OF THE CATHETER. THE PRIMARY PACKAGING OF THE PRODUCT WAS NOT OPENED BEFORE THE SURGERY. THERE WAS NO PHYSICAL DAMAGE, OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808923 ↗
• InjuryAug 3, 2023Signal Artifact/Noise; Patient Device Interaction Problem; Signal Artifact/Noise; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE THAT INCLUDED A REPROCESSED CORONARY SINUS (CS) CATHETER (DIAGNOSTIC EP CATH) AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION/CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS. DURING THE PROCEDURE, ELECTRODES 9 AND 10 OF THE CATHETER WERE NOT DISPLAYING SIGNALS. THE CATHETER WAS NOT REPLACED AND CONTINUED TO BE USED AFTER THE SENSOR ERROR, SINCE THE SENSOR WAS NOT PIVOTAL TO THE CASE. AT THE END OF THE PROCEDURE, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THE EFFUSION WAS DISCOVERED POST-ABLATION VIA A ROUTINE CHECK WITH INTRACARDIAC ECHOCARDIOGRAM IMAGING. THE PATIENT DID NOT HAVE ANY SIGNS OR SYMPTOMS. A PERICARDIOCENTESIS WAS PERFORMED AND LESS THAN 180ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE STABLE. TRANSSEPTAL PUNCTURE WAS PERFORMED TWICE WITH A BAYLIS NEEDLE. ABLATION WAS PERFORMED PRIOR TO NOTING PERICARDIAL EFFUSION. THERE WAS NO EVIDENCE OF STEAM POP. ALSO, NO IMPEDANCE SPIKES NOTED DURING ABLATION. IRRIGATION CATHETER SETTINGS: 8/15 ML, PER INSTRUCTIONS FOR USE. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. PATIENT WA

  Patient problems: Cardiac Perforation

  MAUDE report 17455172 ↗