NA BIO10439072Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10888551014458), received between Jun 18, 2020 and Mar 6, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR CATHETER AND AFTER REMOVING THE SOUNDSTAR® CATHETER FROM THE PACKAGE, THEY NOTICED IT WAS DAMAGED, THE PLASTIC WAS CRACKED AT THE SHAFT. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539260 ↗
• MalfunctionOct 15, 2025Mechanical Jam; Positioning Problem; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND CATHETER AND THE LOCKING MECHANISM FOR THE DEFLECTION ON THE CATHETER WAS LOCKING AND GETTING STUCK IN THE LOCKED POSITION. THE DOCTOR SAID IT WAS LOCKING IN THE DEFLECTED POSITION. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302345 ↗
• MalfunctionMay 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND CATHETER AND WHILE UNPACKING THE CATHETER FOR THE FIRST TIME, THERE WAS BLOOD ON THE HANDLE OF CATHETER. THE DEVICE WAS NOT USED ON THE PATIENT. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978030 ↗
• MalfunctionApr 17, 2025Device Contamination with Body Fluid

  ICE SOUNDSTAR EQUIPMENT USED DURING CASE HAD BLOOD ON THE PART HANDED OFF TO BE PLUGGED INTO OUR ULTRASOUND MACHINE. UNSURE IF THE BLOOD WAS ON THERE WHEN ITEM WAS OPENED OR THIS WAS FROM THE CURRENT PATIENT. STAFF DID NOT COME IN CONTACT WITH THIS. WAS SEEN BY REP HERE FOR OUR EQUIPMENT FOR EP ABLATIONS. BIOSENSE WEBSTER, IRVINE, CA 92618 US.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854089 ↗
• MalfunctionJan 22, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO CATHETER AND THE CATHETER'S TIP WAS CONTAMINATED BY A STICKER IN THE ORIGINAL PACKAGING OF THE CATHETER. WHEN THE USER REMOVED THE CATHETER FROM THE PACKAGING, A STICKER WAS STUCK TO THE TIP. WHEN THE CATHETER WAS REPLACED, THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION IN THIS COMPLAINT. HOWEVER, IT HAS NOT BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209609 ↗
• InjuryMar 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A REPROCESSED CATHETER SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND FOR USE ON GE IMAGING SYSTEM 10F CATHETER AND THE PATIENT EXPERIENCED COMPLETE HEART BLOCK THAT REQUIRED PACEMAKER INSERTION. WHEN MANIPULATING THE CARTO SOUND CATHETER, THE AV NODE WAS TOUCHED, AND THE PATIENT WENT INTO COMPLETE HEART BLOCK. THE AFIB PROCEDURE WAS THEN CANCELLED, AND A PERMANENT PACEMAKER WAS INSERTED. THE PATIENT WAS REPORTED TO BE STABLE, AND THEIR OUTCOME IS UNCHANGED. THE PHYSICIAN DOES NOT ATTRIBUTE THE CAUSE OF THE EVENT TO BE RELATED TO THE PRODUCTS USED. NO TRANSSEPTAL PUNCTURE PERFORMED.

  Patient problems: Heart Block

  MAUDE report 18991664 ↗
• MalfunctionJun 18, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN IMAGING CATHETER, AND FOREIGN MATERIAL WAS IDENTIFIED INSIDE THE DEVICE PACKAGING. IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE OPENING THE STERILE REPROCESSED IMAGING CATHETER, A HAIR-LIKE SUBSTANCE WAS FOUND INSIDE OF IT. THE SURGEON FINISHED THE PROCEDURE WITH ANOTHER INSTRUMENT. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL CLARIFICATION WAS RECEIVED ON THE EVENT. THE HAIR WAS FOUND ON THE USABLE PORTION OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER CARTOSOUND CATHETER. THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT OF THE EVENT. THE FOREIGN MATERIAL ON THE CATHETER THAT WAS IDENTIFIED WHILE OPENING THE STERILE PACKAGING WAS ASSESSED AS A MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171783 ↗

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.