N/A R10439236Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10888551045094), received between Oct 1, 2020 and Feb 10, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026

  ON INSERTION INTO BODY, NO VISIBLE IMAGES.

  Patient problems: Insufficient Information

  MAUDE report 24307587 ↗
• MalfunctionJan 9, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE AND THERE WAS A FOREIGN SUBSTANCE INSIDE THE STERILE PACKAGING OF THE REPROCESSED STERILMED SOUNDSTAR CATHETER. THE SUBSTANCE WAS 2-3MM BLACK "CHUNKS" THAT FELL TO THE FLOOR WHEN THE PACKAGE WAS OPENED. NO PHYSICAL DAMAGE WAS OBSERVED ON THE DEVICE PACKAGING. THE PACKAGE WAS OUT OF BOX HANGING IN A SUPPLY HALLWAY. THE CATHETER WAS REPLACED WITH ANOTHER REPROCESSED STERILMED SOUNDSTAR CATHETER AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029734 ↗
• MalfunctionDec 3, 2025Adverse 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 ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F ULTRASOUND CATHETER. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WITH ANOTHER DEVICE WHICH REQUIRED PERICARDIOCENTESIS. THE PHYSICIAN ATTEMPTED ABLATION INSIDE THE CORONARY SINUS (CS), BUT DUE TO DIFFICULT ANATOMY IT WAS ABORTED. THE PHYSICIAN ATTEMPTED BOTH SHEATH AND CATHETER MANIPULATION INSIDE THE CS FOR APPROXIMATELY 60 MINUTES. AFTER ABORTING THE ABLATION, A PERICARDIAL EFFUSION WAS DISCOVERED BY THE POST CASE INTRACARDIAC ECHOCARDIOGRAM (ICE) AND CONFIRMED BY ICE CATHETER. THE PHYSICIAN ATTEMPTED TO PERFORM PERICARDIOCENTESIS WHICH WAS ABORTED DUE TO INABILITY TO GAIN ACCESS TO THE PERICARDIAL SPACE, AND THE PHYSICIAN'S IMPRESSION OF THE EFFUSION DECREASING. THE PATIENT¿S CONDITION WORSENED, AND THE PATIENT BEGAN SHOWING TAMPONADE PHYSIOLOGY LATER IN THE DAY AND WAS BROUGHT BACK TO THE LAB FOR PERICARDIOCENTESIS WHICH WAS SUCCESSFUL IN REMOVING 300ML OF FLUID. THE PATIENT WAS STABLE. LAST KNOWN STATUS OF THE PATIENT IS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF CONTINUED MONITORING. ONE TRANSSEPTAL PUNCTURE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705554 ↗
• MalfunctionNov 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH TWO REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER¿S. CATHETERS BECAME UNSTERILE DUE TO PACKAGING NOT OPENING PROPERLY. INSTEAD OF RIPPING STRAIGHT DOWN, IT WOULD DO SO DIAGONALLY INSTEAD. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE WAS NOT DROPPED. NO OTHER DAMAGE WAS OBSERVED ON THE BOX/PACKAGING OF THE DEVICE BEFORE OPENING. WHEN THE SLEEVE WAS PULLED APART TO EXPOSE THE CATHETER FOR REMOVAL, THE CLEAR PLASTIC FRONT TORE DIAGONALLY INSTEAD OF SEPARATING FROM THE SOLID WHITE BACK LAYER. WHEN THE CATHETER WAS REMOVED, IT SCRAPED ALONG THE DIAGONAL TEAR OF THE PLASTIC AND THE PHYSICIAN BELIEVED IT WAS LIKELY CONTAMINATED. DUE TO AN ABUNDANCE OF CAUTION, THEY ASKED FOR A NEW CATHETER. THE REPORTER WAS ASKED TO KEEP THE SLEEVES (WHICH DISPLAYED THE ISSUE WHEN OPENING) AND THE CATHETERS TO SEND BACK FOR ANALYSIS. THE OTHER PACKAGING DID NOT APPEAR TO BE RELATED TO THE ISSUE OBSERVED AND WERE DISPOSED OF. THE STERILITY ISSUE WAS ASSESSED AS MDR REPORTABLE UNDER BOTH OF THE REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER¿S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589202 ↗
• MalfunctionNov 18, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH TWO REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER¿S. CATHETERS BECAME UNSTERILE DUE TO PACKAGING NOT OPENING PROPERLY. INSTEAD OF RIPPING STRAIGHT DOWN, IT WOULD DO SO DIAGONALLY INSTEAD. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE WAS NOT DROPPED. NO OTHER DAMAGE WAS OBSERVED ON THE BOX/PACKAGING OF THE DEVICE BEFORE OPENING. WHEN THE SLEEVE WAS PULLED APART TO EXPOSE THE CATHETER FOR REMOVAL, THE CLEAR PLASTIC FRONT TORE DIAGONALLY INSTEAD OF SEPARATING FROM THE SOLID WHITE BACK LAYER. WHEN THE CATHETER WAS REMOVED, IT SCRAPED ALONG THE DIAGONAL TEAR OF THE PLASTIC AND THE PHYSICIAN BELIEVED IT WAS LIKELY CONTAMINATED. DUE TO AN ABUNDANCE OF CAUTION, THEY ASKED FOR A NEW CATHETER. THE REPORTER WAS ASKED TO KEEP THE SLEEVES (WHICH DISPLAYED THE ISSUE WHEN OPENING) AND THE CATHETERS TO SEND BACK FOR ANALYSIS. THE OTHER PACKAGING DID NOT APPEAR TO BE RELATED TO THE ISSUE OBSERVED AND WERE DISPOSED OF. THE STERILITY ISSUE WAS ASSESSED AS MDR REPORTABLE UNDER BOTH OF THE REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER¿S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589199 ↗
• MalfunctionJun 26, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER, ONCE THE CATHETER WAS REMOVED FROM THE PACKAGING WITHOUT DIFFICULTY, THE SERIAL NUMBER TAG WAS ATTACHED WITH WHAT APPEARED TO BE ELECTRICAL TAPE ON THE VERY TIP OF CATHETER. THE TAPE AND TAG WERE REMOVED BY THE SCRUB ASSISTANT BUT A RESIDUE FROM THE TAPE WAS OBSERVED ON THE CATHETER. THE SCRUB TECH TRIED TO CLEAN THE ADHESIVE OFF, BUT THE STAFF AND DOCTOR FELT UNCOMFORTABLE INSERTING THE CATHETER INTO THE BODY AFTERWARDS. IT WAS DETERMINED TO NOT USE THE CATHETER, AND THE DEVICE WAS NOT PLACED INSIDE THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340795 ↗
• MalfunctionMar 20, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND PRIOR TO THE PROCEDURE, WHEN IT WAS OPENED, THERE WAS A STICKY SUBSTANCE ON THE END THAT CONNECTS INTO THE MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653717 ↗
• MalfunctionFeb 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER, AND A FOREIGN OBJECT WAS NOTICED TO BE ON THE CATHETER WHEN IT WAS REMOVED STRAIGHT OUT OF THE PACKAGING. THE CATHETER WAS THOUGHT TO HAVE A CAP OR A PART OF AN OLD SHEATH, A COUPLE OF INCHES FROM THE TIP OF THE CATHETER. THE PIECE SEEMED STUCK ON THE CATHETER. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGING. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411289 ↗
• MalfunctionOct 8, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING PRE-OP FOR AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON GE IMAGING SYSTEM AND THE INSIDE OF THE PACKAGING HAD DEBRIS WHICH WAS POSSIBLY BLOOD. THE CATHETER BAG WAS OPENED BUT THE CATHETER WAS NOT REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402767 ↗
• MalfunctionJul 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A REPROCESSED SOUNDSTAR CATHETER, AND WHEN THE CATHETER WAS REMOVED FROM THE PACKAGE THERE WAS A PIECE OF TAPE STUCK ON THE BLACK PART OF THE HANDLE THAT CONNECTS TO THE ECO CABLE. THE TAPE WAS CLEAR/COLORLESS, AND TEXTURED. THE TAPE DID NOT APPEAR TO BE PART OF THE PACKAGING ITSELF. NO VISIBLE DAMAGE TO THE CATHETER WAS OBSERVED. THE USER DID NOT FEEL COMFORTABLE USING IT. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726748 ↗
• MalfunctionOct 26, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED IMAGING CATHETER AND DURING PREP, WHEN ATTEMPTING TO OPEN THE PACKAGING, THE SIDES WERE GLUED TIGHTLY, WHICH CAUSED THE PACKAGING TO RIP DOWN THE MIDDLE. HOWEVER THE CATHETER STAYED ADHERED ON THE SIDES RENDERING IT NON-STERILE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016885 ↗
• MalfunctionMay 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED IMAGING CATHETER AND WHEN THE CATHETER WAS REMOVED FROM THE PACKAGING IT WAS DISCOVERED THAT THE BLACK COATING AROUND THE DISTAL END OF THE CATHETER WAS PEELING OFF. NO FRAGMENTS WERE GENERATED. THE PRIMARY PACKAGING BOX WAS NOT OPENED BEFORE THE SURGERY. NO PHYSICAL DAMAGE OR OTHER ISSUE WAS OBSERVED ON THE PACKAGE OF THE DEVICE. THE CATHETER WAS REPLACED, AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920596 ↗
• InjuryMar 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH TWO SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER¿S AND SUFFERED A CARDIAC PERFORATION AND CARDIAC TAMPONADE WHICH REQUIRED SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. THE REPROCESSED CATHETER (SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER) WAS NOT SHOWING UP ON THE S70 ULTRASOUND MACHINE BUT WAS SHOWING UP ON THE CARTO 3 SYSTEM. THEY REPLACED THE SWIFT LINK CABLE BUT THAT DID NOT RESOLVE THE ISSUE. THE CATHETER WAS REPLACED AND THAT DID NOT RESOLVE THE ISSUE. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED. THE CALLER REPORTED THERE WERE NO VISIBLE SIGNS ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECO. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND IT WAS UNKNOWN HOW MUCH FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED. THE ABLATION CATHETER WAS NEVER USED. THE PHYSICIAN WAS PERFORMING A TRANSSEPTAL PUNCTURE AND NOTED A POSSIBLE FLICKER AND POSSIBLE SCREEN FREEZE ON THE ICE IMAGING. THE PHYSICIAN PERFORMED THE TRANSSEPTAL PUNCTURE WITH A NEEDLE. SALES REP REPORTS

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 16548093 ↗
• InjuryMar 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH TWO SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER¿S AND SUFFERED A CARDIAC PERFORATION AND CARDIAC TAMPONADE WHICH REQUIRED SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. THE REPROCESSED CATHETER (SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER) WAS NOT SHOWING UP ON THE S70 ULTRASOUND MACHINE BUT WAS SHOWING UP ON THE CARTO 3 SYSTEM. THEY REPLACED THE SWIFT LINK CABLE BUT THAT DID NOT RESOLVE THE ISSUE. THE CATHETER WAS REPLACED AND THAT DID NOT RESOLVE THE ISSUE. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED. THE CALLER REPORTED THERE WERE NO VISIBLE SIGNS ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECO. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND IT WAS UNKNOWN HOW MUCH FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED. THE ABLATION CATHETER WAS NEVER USED. THE PHYSICIAN WAS PERFORMING A TRANSSEPTAL PUNCTURE AND NOTED A POSSIBLE FLICKER AND POSSIBLE SCREEN FREEZE ON THE ICE IMAGING. THE PHYSICIAN PERFORMED THE TRANSSEPTAL PUNCTURE WITH A NEEDLE. SALES REP REPORTS

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 16548087 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A REPROCESSED SOUNDSTAR ECO 8FG ULTRASOUND CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE MAPPING PHASE OF THE PROCEDURE, A CARDIAC TAMPONADE WAS NOTICED AS THE PATIENT¿S BLOOD PRESSURE DROPPED. THE CARDIAC TAMPONADE WAS CONFIRMED BY INTRACARDIAC AND BODY SURFACE ECHOCARDIOGRAM. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND APPROXIMATELY 350ML OF FLUID WERE REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN COMMENTED THAT THE EVENT WAS RELATED TO MANIPULATION OF THE ULTRASOUND CATHETER AS THEY NEVER CAME ON ABLATION AND THE PHYSICIAN SAW THE PATIENT HAVING BLOOD PRESSURE ISSUES WHILE MANIPULATING THE ULTRASOUND CATHETER. THE PATIENT HAD TO STAY IN THE HOSPITAL TO BE MONITORED FOR LONGER THAN INTENDED AND HAS FULLY RECOVERED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH THE BAYLIS NEEDLE. ADDITIONAL MAPPING WAS PERFORMED WITH A PENTARAY CATHETER THAT WAS ON A PRESSURE BAG. NO ERROR MESSAGES WERE OBSERVED ON EQUIPMENT.

  Patient problems: Cardiac Tamponade

  MAUDE report 11032768 ↗
• MalfunctionOct 1, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THREE REPROCESSED SOUNDSTAR CATHETER PACKAGES HAD HOLES. THE DEVICES WERE NOT REMOVED FROM PACKAGING AND WERE NOT USED ON PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617598 ↗
• MalfunctionOct 1, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THREE REPROCESSED SOUNDSTAR CATHETER PACKAGES HAD HOLES. THE DEVICES WERE NOT REMOVED FROM PACKAGING AND WERE NOT USED ON PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617587 ↗
• MalfunctionOct 1, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THREE REPROCESSED SOUNDSTAR CATHETER PACKAGES HAD HOLES. THE DEVICES WERE NOT REMOVED FROM PACKAGING AND WERE NOT USED ON PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617576 ↗