NA BIO10438577Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888551014441), received between Nov 16, 2021 and Mar 11, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 other recall cover devices cleared under the same FDA submission (K110076); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, APPROXIMATELY 75 YEARS OLD, UNDERWENT A RIGHT SIDED ATRIAL TACHYCARDIA ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR CATHETER AND THE PATIENT EXPERIENCED ASYSTOLE, WHICH REQUESTED EXTERNAL PACING. IN ADDITION, THE PATIENT EXPERIENCED CHEST PAIN AND PERICARDIAL EFFUSION DUE TO CARDIAC PERFORATION TREATED WITH PERICARDIOCENTESIS WITH A NON-STERILMED QDOT CATHETER. THE PATIENT COMPLAINED OF CHEST PAIN DURING THE PROCEDURE AFTER ABOUT 15 MINUTES OR MORE INTO THE CASE. THE CHEST PAIN WAS BELIEVED TO BE FROM PACING AND THE PROCEDURE CONTINUED. A COUPLE OF MINUTES AFTER THE PATIENT COMPLAINED OF CHEST PAIN, A PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED USING THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) SOUNDSTAR CATHETER. THE PERICARDIAL EFFUSION WAS DUE TO CARDIAC PERFORATION. THERE WAS NO PERICARDIAL EFFUSION AT BASELINE. THE MEDICAL INTERVENTION PROVIDED WAS INTUBATION AND PERICARDIOCENTESIS IN WHICH 150ML OF FLUID WAS REMOVED. THE PATIENT ALREADY HAD A LEFT BUNDLE BLOCK FROM THE START OF THE PROCEDURE. THE DECANAV CATHETER AND QDOT CATHETER WERE PULLED BACK TO THE SHEATH AND THE ICE CATHETER REMAINED IN THE RIGHT VENTRICLE. THE PHYSICIAN MANEUVERED THE

  Patient problems: Asystole

  MAUDE report 24570915 ↗
• InjuryNov 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A REPROCESSED SOUNDSTAR® ECO 10F DIAGNOSTIC ULTRASOUND CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED SURGICAL INTERVENTION. DURING THE AFIB CASE, AFTER THE PHYSICIAN WENT TRANSSEPTAL WITH THE SOUNDSTAR, THE BLOOD PRESSURE DROPPED SIGNIFICANTLY, THEN THE PHYSICIAN NOTICED THE EFFUSION. THE INJURY WAS CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAM AND BY PERFORMING A TRANSESOPHAGEAL ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS ATTEMPTED BUT WERE NOT ABLE TO DRAIN ANY FLUIDS. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS THEN TAKEN TO CARDIOTHORACIC SURGERY. THE LAST KNOWN STATUS OF THE PATIENT WAS STABLE. IT IS UNKNOWN WHAT LED TO THE INJURY. THE PLAN WAS TO DO PULSED FIELD ABLATION (PFA) WITH BOSTON SCIENTIFIC, BUT NO ABLATING WAS DONE BECAUSE AFTER TRANSSEPTAL, AN EFFUSION WAS NOTICED. THE SOUNDSTAR CATHETER FUNCTIONED AS EXPECTED, HOWEVER IT IS UNCLEAR IF THE SOUNDSTAR CATHETER WAS CONSIDERED TO BE A CONTRIBUTING FACTOR TO THE REPORTED EVENT.

  Patient problems: Cardiac Tamponade

  MAUDE report 20753846 ↗
• MalfunctionNov 16, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED CATHETER SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND FOR USE ON SIEMENS IMAGING SYSTEM AND A STERILITY ISSUE OCCURRED. THE PACKAGING HAD A SMALL PUNCTURE THE SIZE OF A SMALL PINKY FINGERNAIL IN THE POUCH. THE CATHETER WAS NOT DAMAGED BUT WAS NO LONGER STERILE. IT WAS NOTED THAT THE PACKAGING WAS RECEIVED DAMAGED. THE HOLE WAS NOTICED BEFORE OPENING THE PRIMARY PACKAGING, SO IT WAS NOT OPENED. ANOTHER CATHETER WAS USED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820396 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110076. One submission often covers many models, so check the product and lot details in each record.

• Z-0059-2015 · Sep 24, 2014 · Terminated
  Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.