NA BIOBD710DF282CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888551005920), received between Nov 16, 2021 and Aug 27, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A REPROCESSED EZ STEER BI-DIRECTIONAL CS CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. THE PATIENT HAD A PERICARDIAL EFFUSION. AFTER OBTAINING TRANSSEPTAL ACCESS AND DELIVERING THE FIRST ABLATION LESION, THE CERTIFIED REGISTERED NURSE ANESTHETIST NOTED A MINOR DROP IN BLOOD PRESSURE. THE PHYSICIAN THEN SCANNED THE HEART VIA INTRACARDIAC ECHOCARDIOGRAM IMAGING WITH A SOUNDSTAR CATHETER AND NOTED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND 700 ML OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE STABLE AND PATIENT CONDITION HAS IMPROVED. PHYSICIAN¿S OPINION ON THE CAUSE OF THE ISSUE IS THAT THE PHYSICIAN INITIALLY THOUGHT IT WAS CAUSED BY THE TRANSSEPTAL ACCESS SINCE THERE WAS A "TOUGH" TRANSSEPTAL. DURING THE PERICARDIOCENTESIS, ONLY 100-200 ML OF FLUID WAS INITIALLY REMOVED. WHEN THE CS CATHETER WAS REMOVED FROM THE BODY, MORE FLUID WAS ABLE TO BE REMOVED. THE PHYSICIAN IS UNSURE WHETHER THE CS CATHETER HAD ANYTHING TO DO WITH THE EFFUSION. ONE ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION, THERE WAS NO EVIDENCE OF STEAM PO

  Patient problems: Cardiac Tamponade

  MAUDE report 20077078 ↗
• MalfunctionJun 21, 2024Material Separation; Tear, Rip or Hole in Device Packaging; Packaging Problem; Material Separation; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED EZ STEER BI-DIRECTIONAL CS DEFLECTABLE CATHETER AND UPON OPENING THE PACKAGING, THE CATHETER WAS DISCOVERED TO BE BROKEN IN HALF MIDWAY UP THE SHAFT. THE SHAFT WAS COMPLETELY BROKEN MIDWAY UP THE CATHETER, INCLUDING THE PLASTIC CASING SURROUNDING THE CATHETER INSIDE THE PACKAGING. WIRES WERE FULLY EXPOSED AT THE BREAK POINT. DAMAGING WAS BELOW THE ELECTRODES, SO NO LIFTED OR SHARP RINGS WERE SEEN. THERE WAS ALSO SOME DAMAGE TO THE PACKAGING AS WELL. OUTER BOX WAS DAMAGED BUT DIDN'T APPEAR TO BE EXTREME ENOUGH TO CORRELATE WITH THE CATHETER DAMAGE. THE POUCH SEAL WAS SLIGHTLY TORN WHERE THE CATHETER HAD SNAPPED. PRIMARY PACKAGING WAS OPENED PRIOR TO GETTING ACCESS, AND THE CATHETER WAS IMMEDIATELY REPLACED. THE PROCEDURE CONTINUED WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581501 ↗
• MalfunctionApr 4, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AND ELECTROPHYSIOLOGY STUDY WITH A DIAGNOSTIC EP CATHETER AND THE CATHETER ONLY HAD TWO WORKING POLES WITH NOISE ON THE OTHER THREE. THE CATHETER WAS EXCHANGED, AND THE ISSUE RESOLVED. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS EVENT IS NOT REPORTABLE. UPON RECEIVING THE DEVICE FOR EVALUATION, VISUAL INSPECTION WAS PERFORMED, AND THE SHAFT ABOVE THE ELECTRODE #2 WAS MELTED. THIS FINDING IS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047657 ↗
• MalfunctionNov 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN STENOSIS PROCEDURE WITH A REPROCESSED DIAGNOSTIC EP CATHETER AND UPON OPENING THE DEVICE, SOME OF THE INTERNAL PARTS OF THE DISTAL ELECTRODES AT THE TIP OF THE CATHETER WERE EXPOSED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GET CLARIFICATION ON THIS EVENT, HOWEVER NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823748 ↗