SOUNDSTAR 10439011Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10846835008852), received between Oct 24, 2017 and Sep 5, 2025 — classified as 2 deaths, 50 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (31 reports).

1 other recall cover devices cleared under the same FDA submission (K140318); 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 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Material Separation; Manufacturing, Packaging or Shipping Problem; Material Separation; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND THE "CASING ON THE DISTAL END OF THE SOUNDSTAR® CATHETER" APPEARED TO HAVE "PLASTIC SHAVING OFF THE SIDE," LIKE IT WAS "RIPPED OFF." THE SOUNDSTAR® CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983327 ↗
• InjuryJun 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED DURING ATRIAL FIBRILLATION ABLATION PROCEDURE A SOUNDSTAR CATHETER WAS INSERTED IN THE PATIENT, BUT AFTER APPLICATION OF DC (DIRECT CURRENT) TO STOP FIBRILLATION, THE PATIENT HAS BRADYCARDIA REQUIRING PACEMAKER IMPLANTATION. DURING PAFIB (PERSISTENT ATRIAL FIBRILLATION) PROCEDURE, A SOUNDSTAR CATHETER WAS INSERTED INTO THE HEART BEFORE BRADYCARDIA OCCURRED. THE MEDICAL TEAM INDICATED THAT THE PATIENT WAS GOING TO BE TREATED FOR PERSISTENT ATRIAL FIBRILLATION PROCEDURE (ATRIAL FIBRILLATION PERSISTED FROM BEFORE ADMISSION TO AFTER ENTERING THE ROOM). AFTER THE PATIENT ENTERED THE ROOM, DC WAS USED TO STOP THE FIBRILLATION, BUT BRADYCARDIA OCCURRED, MAKING IT NO LONGER SAFE TO CONTINUE THE PROCEDURE. IMPLANTATION OF A PACEMAKER WAS CONSIDERED NECESSARY. THE PROCEDURE WAS CANCELED AT THE PHYSICIAN'S DISCRETION AND NOT CANCELED DUE TO A MALFUNCTION OF THE EP (ELECTROPHYSIOLOGY) PRODUCTS. ADDITIONALLY, THERE WERE AIR BUBBLES UPSTREAM IN THE TUBE. THE AIR BUBBLES WERE NOT EMBEDDED IN THE TUBE MATERIAL ITSELF. THERE WERE NO SIGNS OF AIR MOVING EVEN AFTER TAPPING. THE TUBING SET WAS WITH ANOTHER NEW ONE. THE CATHETERS WERE DISCARDED IN THE HOSPITAL BECAUSE THE PROCEDURE

  Patient problems: Bradycardia

  MAUDE report 22137405 ↗
• MalfunctionSep 19, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT ATRIAL FLUTTER (R-AFL) ABLATION PROCEDURE WITH A SOUNDSTAR FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A BROKEN SHAFT WHICH EXPOSED THE INTERNAL COMPONENTS. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE SOUNDSTAR® CATHETER HAD A CATHETER SENSOR ERROR (ERROR#6150) DISPLAYED ON THE CARTO® 3 SYSTEM. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED MAGNETIC SENSOR ERROR IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 27-AUG-2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A BROKEN SHAFT WHICH EXPOSED THE INTERNAL COMPONENTS. THESE FINDINGS WERE REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20259890 ↗
• InjurySep 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A SOUNDSTAR AND THE PATIENT EXPERIENCED ST ELEVATION/MYOCARDIAL INFARCTION THAT CAUSED CASE CANCELLATION AND REQUIRED PATIENT TO NEED PROLONGED HOSPITALIZATION. BEFORE BROKENBROUGH, ST ELEVATION OCCURRED. THE ST NORMALIZED WITHIN MINUTES BUT THE ABLATION PROCEDURE WAS CANCELLED JUST IN CASE. PATIENT RECOVERED, HOWEVER. REQUIRED EXTENDED HOSPITALIZATION FOR FOLLOW UP OBSERVATION. THE PHYSICIAN REPORTED THE CAUSE OF THE ADVERSE EVENT IS UNKNOWN. THE PATIENT ORIGINALLY HAD A HISTORY OF VARIOUS TREATMENTS AND HAD BEEN TREATED FOR CORONARY PROCEDURES. PATIENT HAS A HISTORY OF MYOCARDIAL INFARCTION AND ANGINA PECTORIS. ABLATION WAS NOT PERFORMED. NO ABNORMALITY OBSERVED PRIOR TO USE OF THE PRODUCT. ON 2-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICTING THAT NO MAPPING WAS PERFORMED AND THE ONLY CATHETER INSIDE THE PATIENT'S BODY WAS THE SOUNDSTAR CATHETER. AS SUCH, THE AWARENESS DATE IS THE DATE ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SOUNDSTAR WAS THE ONLY DEVICE INSIDE THE PATIENT'S BODY AND THAT THERE WAS A NEW AREA OF INFARCT. THE PATIENT HAD A HISTORY OF MYOCARDIAL INFARCTION, AN

  Patient problems: Ischemic Heart Disease; Myocardial Infarction

  MAUDE report 20136263 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR AND THE CATHETER TIP WAS BROKEN. THE DEVICE WAS EXCHANGED TO CONTINUE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923881 ↗
• MalfunctionJul 24, 2024Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS NOTED THAT AFTER OPENING THE ULTRASOUND CATHETER, THEY NOTICED A HAIR LODGED INTO THE CATHETER HANDLE. IT WAS NOTICED RIGHT AFTER IT WAS TAKEN OUT OF THE PACKAGE. THE REPORTER NOTED THAT THE HAIR WAS LOCATED ON THE CATHETER TO ULTRASOUND SYSTEM CONNECTION PORT. WHEN THE CATHETER WAS EXCHANGED, THE ISSUE WAS RESOLVED, AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823533 ↗
• DeathJul 22, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A SOUNDSTAR CATHETER, AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND OPEN-HEART SURGERY, HOWEVER THE PATIENT DIED. DURING AN AFIB CASE, A PERFORATION OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) WAS NOTICED WITHIN THE FIRST 20 MINUTES OF THE PROCEDURE. THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT AND A PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAM (ICE). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND THE PATIENT WAS TAKEN INTO OPEN HEART SURGERY. THE PATIENT WAS NOT STABLE. THE PHYSICIAN BELIEVED THE PERFORATION WAS FROM THE SOUNDSTAR CATHETER DURING IMAGING SINCE IT WAS IN THE RVOT WHERE THE PERFORATION WAS DISCOVERED. THE EVENT OCCURRED DURING INITIAL ICE IMAGING, DURING THE FIRST 15 MINUTES OF THE PROCEDURE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO ABLATION WAS PERFORMED. THE OUTCOME WAS DEATH. THE CAUSE OF DEATH WAS CARDIOVASCULAR FAILURE DURING SURGERY THAT DAY TO REPAIR THE PERFORATION. (B)(4).

  Patient problems: Atrial Fibrillation

  MAUDE report 19798807 ↗
• DeathJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A SOUNDSTAR CATHETER, AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND OPEN-HEART SURGERY, HOWEVER THE PATIENT DIED. DURING AN AFIB CASE, A PERFORATION OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) WAS NOTICED WITHIN THE FIRST 20 MINUTES OF THE PROCEDURE. THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT AND A PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAM (ICE). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND THE PATIENT WAS TAKEN INTO OPEN HEART SURGERY. THE PATIENT WAS NOT STABLE. THE PHYSICIAN BELIEVED THE PERFORATION WAS FROM THE SOUNDSTAR CATHETER DURING IMAGING SINCE IT WAS IN THE RVOT WHERE THE PERFORATION WAS DISCOVERED. THE EVENT OCCURRED DURING INITIAL ICE IMAGING, DURING THE FIRST 15 MINUTES OF THE PROCEDURE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO ABLATION WAS PERFORMED. THE OUTCOME WAS DEATH. THE CAUSE OF DEATH WAS CARDIOVASCULAR FAILURE DURING SURGERY THAT DAY TO REPAIR THE PERFORATION.

  Patient problems: Cardiac Perforation

  MAUDE report 19722635 ↗
• InjuryMay 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND THE PATIENT EXPERIENCED THROMBOSIS THAT CAUSED CASE CANCELLATION. THE PHYSICIAN TRIED TO DO LEFT ATRIUM (LA) MAPPING WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, BUT THE PROCEDURE WAS STOPPED BECAUSE LEFT ATRIAL APPENDAGE (LAA) THROMBUS WAS SEEN ON THE ECHO IMAGE. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19354726 ↗
• InjuryMay 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND THE PATIENT EXPERIENCED THROMBOSIS THAT CAUSED CASE CANCELLATION. THE PHYSICIAN TRIED TO DO LEFT ATRIUM (LA) MAPPING WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, BUT THE PROCEDURE WAS STOPPED BECAUSE LEFT ATRIAL APPENDAGE (LAA) THROMBUS WAS SEEN ON THE ECHO IMAGE. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19343208 ↗
• MalfunctionMay 6, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PERSISTENT ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A BROKEN SHAFT (IT WAS BROKEN IN THE MIDDLE PORTION). DURING THE PROCEDURE, ONCE THE SOUNDSTAR ECO 8F ULTRASOUND CATHETER ENTERED THE HEART A CARTO ERROR 6150 (CATHETER SENSOR ERROR) OCCURRED. THE SOUNDSTAR CATHETER WAS UNPLUGGED AND REPLUGGED IN WITH FIX TO THE ERROR FOR APPROXIMATELY 30 SECONDS BEFORE THE ISSUE RECURRED. THIS WAS TRIED AGAIN WITH A SHORT FIX FOR ANOTHER 30 SECONDS BEFORE ERROR 6150 POPPED UP AGAIN. A NEW SOUNDSTAR ECO DONGLE WAS TRIED WITH NO FIX TO THE ERROR, BUT THAT DIDN'T WORK EITHER. A NEW SOUNDSTAR CATHETER WAS USED AND THE ISSUE RESOLVED. THE OVERALL SURGICAL DELAY WAS APPROXIMATELY 6 MINUTES. THE CASE CONTINUED ON WITHOUT ANY FURTHER ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256359 ↗
• MalfunctionApr 30, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PERSISTENT ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A BROKEN SHAFT (IT WAS BROKEN IN THE MIDDLE PORTION). DURING THE PROCEDURE, ONCE THE SOUNDSTAR ECO 8F ULTRASOUND CATHETER ENTERED THE HEART A CARTO ERROR 6150 (CATHETER SENSOR ERROR) OCCURRED. THE SOUNDSTAR CATHETER WAS UNPLUGGED AND REPLUGGED IN WITH FIX TO THE ERROR FOR APPROXIMATELY 30 SECONDS BEFORE THE ISSUE RECURRED. THIS WAS TRIED AGAIN WITH A SHORT FIX FOR ANOTHER 30 SECONDS BEFORE ERROR 6150 POPPED UP AGAIN. A NEW SOUNDSTAR ECO DONGLE WAS TRIED WITH NO FIX TO THE ERROR, BUT THAT DIDN'T WORK EITHER. A NEW SOUNDSTAR CATHETER WAS USED AND THE ISSUE RESOLVED. THE OVERALL SURGICAL DELAY WAS APPROXIMATELY 6 MINUTES. THE CASE CONTINUED ON WITHOUT ANY FURTHER ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19216190 ↗
• MalfunctionOct 19, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE WHICH INCLUDED A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND A RESIDUE WAS OBSERVED ON THE TIP OF THE SOUNDSTAR CATHETER. THE CATHETER WAS NOT USED FOR THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967634 ↗
• MalfunctionOct 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE WHICH INCLUDED A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND A RESIDUE WAS OBSERVED ON THE TIP OF THE SOUNDSTAR CATHETER. THE CATHETER WAS NOT USED FOR THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17900858 ↗
• MalfunctionOct 2, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND WHILE ATTEMPTING TO ADVANCE THE CATHETER THERE WAS RESISTANCE FROM THE HEART. CATHETER ADVANCEMENT WAS ATTEMPTED MULTIPLE TIMES INTO THE RIGHT ATRIUM. THE MEDICAL TEAM DIDN'T ATTEMPT TO MANIPULATE THE CATHETER. THE MEDICAL TEAM PULLED THE CATHETER OUT OF THE BODY AND IT APPEARED THAT THE TIP OF THE CATHETER HAS A KNOT IN IT; IT APPEARED AS IF THE DISTAL END WAS BENT AFTER REMOVAL. THE CATHETER HAD BEEN STUCK IN A CONTRACTED POSITION. UPON REPLACING THE CATHETER THE ISSUE WAS RESOLVED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. THE CATHETER STUCK IN A CONTRACTED POSITION IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852101 ↗
• MalfunctionSep 27, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND WHILE ATTEMPTING TO ADVANCE THE CATHETER THERE WAS RESISTANCE FROM THE HEART. CATHETER ADVANCEMENT WAS ATTEMPTED MULTIPLE TIMES INTO THE RIGHT ATRIUM. THE MEDICAL TEAM DIDN'T ATTEMPT TO MANIPULATE THE CATHETER. THE MEDICAL TEAM PULLED THE CATHETER OUT OF THE BODY AND IT APPEARED THAT THE TIP OF THE CATHETER HAS A KNOT IN IT; IT APPEARED AS IF THE DISTAL END WAS BENT AFTER REMOVAL. THE CATHETER HAD BEEN STUCK IN A CONTRACTED POSITION. UPON REPLACING THE CATHETER THE ISSUE WAS RESOLVED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. THE CATHETER STUCK IN A CONTRACTED POSITION IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17827977 ↗
• MalfunctionAug 10, 2023

  CATHETER SENSOR ERROR NOTED AFTER CATHETER INSERTED INTO BODY. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497153 ↗
• MalfunctionJul 20, 2023Contamination /Decontamination Problem; Communication or Transmission Problem; Contamination /Decontamination Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND A DEBRIS WAS FOUND ON THE CATHETER. IT WAS REPORTED THAT WHEN THE CATHETER WAS OPENED, THERE WAS A DEBRIS FOUND ON THE SOUNDSTAR CATHETER. THE COLOR AND SIZE OF THE DEBRIS ARE ¿DIFFICULT TO UNDERSTAND¿. ¿SWEPT THE DEBRIS AWAY AND USED¿. THE CUSTOMER FOUND THE FOREIGN MATTER, BUT THE CUSTOMER USED IT ON THE PATIENT AFTER THE FOREIGN MATTER WAS REMOVED. A PICTURE WAS PROVIDED, AND AN EXPLANATION WAS PROVIDED AS WELL, STATING THAT THIS FOREIGN SUBSTANCE IS FOUND AFTER IT WAS USED. THIS FOREIGN OBJECT IS DIFFERENT FROM THE FOREIGN OBJECT FOUND AT THE TIME OF OPENING THE PACKAGE. IT WAS ALSO REPORTED THAT THE CATHETER WAS NOT RECOGNIZED ON THE ULTRASOUND MACHINE. RECONNECTING THE CABLE DID NOT SOLVE THE PROBLEM. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE ULTRASOUND RECOGNITION ISSUE WAS ASSESSED AS NOT MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367622 ↗
• MalfunctionJul 6, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND AN OPEN POUCH SEAL OCCURRED. IT WAS REPORTED THE PACKAGE WAS DAMAGED AND TORN. THERE WAS NO CRUSHED BOX, ONLY A HOLE IN THE INSIDE PACKAGING. THE ISSUE WAS IDENTIFIED BEFORE THE PROCEDURE, DURING PREPARATION. THERE WAS NO DAMAGE TO THE DEVICEAS IT WAS SECURED PROPERLY IN THE TRAY. THE ISSUE WAS RESOLVED BY REPLACING THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER TO ANOTHER NEW ONE AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17275683 ↗
• MalfunctionMay 5, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A SOUNDSTAR CATHETER AND AN INTERNAL COMPONENTS EXPOSED ISSUE OCCURRED. THE SOUNDSTAR CATHETER WAS ABLE TO BE USED DURING THE PROCEDURE WITHOUT ANY PROBLEMS, BUT FELT DISCOMFORT WHEN THE CATHETER WAS REMOVED FROM THE INTRACARDIAC AT THE END OF THE PROCEDURE. WHEN CHECKED THE TIP OF THE CATHETER, A WIRE-LIKE OBJECT WAS STICKING OUT. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. SO FAR, THERE WAS NO ADVERSE EVENT. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR AN INTERNAL COMPONENTS EXPOSED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876390 ↗
• MalfunctionMar 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND FOREIGN MATERIAL INSIDE THE PACKAGING OUTSIDE OF SPECIFICATION ISSUE OCCURRED. IT WAS REPORTED THAT WHEN THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER WAS OPENED, THERE WAS WHITE " PIXIE DUST " ON THE HANDLE. THEY WIPED DOWN THE CATHETER AND USED IT FOR THE REST OF THE PROCEDURE. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATERIAL INSIDE THE PACKAGING OUTSIDE OF SPECIFICATION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625699 ↗
• MalfunctionMar 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AND ATRIAL FLUTTER (AFL)] PROCEDURE WITH SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND A FOREIGN MATERIAL ON USABLE LENGTH OF THE CATHETER ISSUE OCCURRED. IT WAS REPORTED THAT WHEN THE CATHETER PACKAGING WAS OPENED, THEY DISCOVERED A "WHITE POWDERY SUBSTANCE ON THE LENGTH OF THE CATHETER AND THE HANDLE." THE BIOSENSE WEBSTER (BWI) REPRESENTATIVE STATED THAT THE STAFF DID NOT FEEL COMFORTABLE USING THE CATHETER. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE FOREIGN MATERIAL ON USABLE LENGTH OF THE CATHETER ISSUE IS MDR REPORTABLE TO THE FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625691 ↗
• MalfunctionMar 28, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND A FOREIGN MATERIAL WAS OBSERVED. IT WAS REPORTED THAT WHEN THE CATHETER WAS TAKEN OUT OF THE PACKAGE, SOME "WHITE DUST" WAS OBSERVED AT THE END OF THE CATHETER HANDLE. THE BWI REPRESENTATIVE STATED THAT THEY CONTINUED TO USE THE CATHETER SINCE NO SUBSTANCE WAS FOUND ON THE LENGTH OF THE CATHETER. NO ISSUES WERE REPORTED DURING THE PROCEDURE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION; HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. WITH THE INFORMATION CURRENTLY AVAILABLE, THIS WAS ASSESSED AS MDR REPORTABLE TO THE FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625689 ↗
• MalfunctionMar 20, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND A FOREIGN MATERIAL WAS OBSERVED. IT WAS REPORTED THAT WHEN THE CATHETER WAS TAKEN OUT OF THE PACKAGE, SOME "WHITE DUST¿ WAS OBSERVED AT THE END OF THE CATHETER HANDLE. THE BWI REPRESENTATIVE STATED THAT THEY CONTINUED TO USE THE CATHETER SINCE NO SUBSTANCE WAS FOUND ON THE LENGTH OF THE CATHETER. NO ISSUES WERE REPORTED DURING THE PROCEDURE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION; HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. WITH THE INFORMATION CURRENTLY AVAILABLE, THIS WAS ASSESSED AS MDR REPORTABLE TO THE FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577254 ↗
• MalfunctionMar 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND FOREIGN MATERIAL INSIDE THE PACKAGING OUTSIDE OF SPECIFICATION ISSUE OCCURRED. IT WAS REPORTED THAT WHEN THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER WAS OPENED, THERE WAS WHITE " PIXIE DUST " ON THE HANDLE. THEY WIPED DOWN THE CATHETER AND USED IT FOR THE REST OF THE PROCEDURE. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATERIAL INSIDE THE PACKAGING OUTSIDE OF SPECIFICATION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553854 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140318. One submission often covers many models, so check the product and lot details in each record.

• Z-0003-2016 · Sep 10, 2015 · Terminated
  SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualiza