SOUNDSTAR SNDSTR10Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10846835000139), received between Feb 16, 2023 and Dec 3, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) - PAROXYSMAL ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER AND DURING THE OPERATION, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND DEFLECTION TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED THAT THE SHAFT OF THE DEVICE WAS BENT AND THAT THERE WAS A STAPLE PIERCING THROUGH THE SHAFT OF THE DEVICE, ADDITIONALLY, CORROSION IN THE STAPLE WAS OBSERVED IN THE PORTION THAT PIERCED THROUGH THE SHAFT. THESE FINDINGS ARE MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707079 ↗
• MalfunctionJun 11, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND AFTER THE KNOB WAS ROTATED, IT COULD NOT BE AUTOMATICALLY RETURN TO THE INITIAL POSITION AND NEEDED TO BE CORRECTED MANUALLY. HOWEVER, THE MEDICAL TEAM THEN CONFIRMED THAT THEY WERE UNABLE TO MANUALLY ROTATED THE DEFLECTING KNOBS AT ALL. THE CURVE WOULD ALSO REFUSE TO STRAIGHTEN ITSELF WHEN RELEASING THE LOCKING MECHANISM. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE DEVICE OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186531 ↗
• MalfunctionMay 29, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER AND THE MEDICAL TEAM DISCOVERED THAT AFTER THE KNOB IS ROTATED, IT CANNOT AUTOMATICALLY RETURN TO THE INITIAL POSITION. THE CURVE WAS NOT STRAIGHTENING BY ITSELF. EVEN THROUGH MANUAL MANIPULATION, THE MEDICAL TEAM FOUND THAT IT WAS IMPOSSIBLE TO RETURN THE CURVE TO ITS NEUTRAL POSITION. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE ISSUE OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110892 ↗
• MalfunctionMay 5, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR AND THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. IT WAS INITIALLY REPORTED THERE WAS A DEFLECTION ISSUE DURING THE OPERATION. THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. THE CUSTOMER¿S REFLECTION ISSUE DEFLECTION ISSUE WAS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. ON 9-APR-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CURVE WAS NOT STRAIGHTENING BY ITSELF WHEN RELEASING THE LOCKING MECHANISM; IT WAS NOT POSSIBLE AT ALL TO RETURN TO ITS NEUTRAL POSITION. BASED ON THE NEW ADDITIONAL INFORMATION WHICH CONFIRMS THE DEFLECTION WAS STUCK, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965194 ↗
• InjuryAug 6, 2024Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER AND THE PATIENT EXPERIENCED DELAY IN SURGERY WHICH RESULTED IN AN INCREASE RISK TO THE PATIENT. VISUALIZATION ISSUE. FOURTEEN DAYS AGO, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SURGERY. WHEN THE THREE-DIMENSIONAL DIAGNOSTIC ULTRASOUND CATHETER WAS USED DURING THE SURGERY, THE SCREEN SHOWED NO IMAGING. THE DOCTOR PLUGGED AND CONNECTED FOR SEVERAL TIMES AND STILL HAD NO IMAGE. AFTER SHUTTING DOWN AND RESTARTING, IT RETURNED TO NORMAL. THE SURGERY WAS SUCCESSFULLY COMPLETED, THE OPERATION TIME WAS PROLONGED AND THE SURGICAL RISK FACTOR WAS INCREASED. ADDITIONAL INFORMATION WAS RECEIVED. THE DURATION OF THE DELAY WAS UNKNOWN. THE PATIENT WAS IN THE ROOM AT THE TIME OF THE DELAY. IN THE PHYSICIAN¿S OPINION, THE DELAY DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY TO THE PATIENT. NO INTERVENTION WAS REQUIRED DUE TO THE DELAY. AFTER TROUBLESHOOTING, THE PROBLEM WAS SUCCESSFULLY RESOLVED. THE VISUALIZATION ISSUE (NO IMAGE) WAS ASSESSED AS NOT REPORTABLE. THE DELAY IN SURGERY WHICH RESULTED IN AN INCREASE RISK TO THE PATIENT WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923706 ↗
• InjuryJun 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  INITIALLY THE ADVERSE EVENT WAS ASSESSED AND REPORTED UNDER THE ABLATION CATHETER "THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER". HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON 22-MAY-2024 STATING THAT EVENT WAS LIKELY CAUSED BY MANEUVERING THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND OCCURRED DURING THE MAPPING PHASE. THEREFORE, THIS EVENT WAS REASSESSED AS MDR REPORTABLE UNDER THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND THE OCTARAY MAPPING CATHETER. THE AWARENESS DATE FOR THE REPORTABLE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND AN OCTARAY MAPPING CATHETER IS 22-MAY-2024. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER" WAS REASSESSED TO A NOT REPORTABLE CONCOMITANT PRODUCT. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) ABLATION WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND AN OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. AFTER MAPPING IN THE RIGHT ATRIUM WITH THE OCTARAY MAPPING CATHETER, A TRANSSEPTAL PROCEDURE WAS PERFORMED. THE VIZIGO SHEATH AND OCTARAY MAPPING CATHETER WENT INTO THE LEFT ATRIUM TO MAP. THE OCTARA

  Patient problems: Atrial Flutter

  MAUDE report 19608577 ↗
• InjuryJun 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  INITIALLY THE ADVERSE EVENT WAS ASSESSED AND REPORTED UNDER THE ABLATION CATHETER ¿THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER¿. HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON 22-MAY-2024 STATING THAT EVENT WAS LIKELY CAUSED BY MANEUVERING THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND OCCURRED DURING THE MAPPING PHASE. THEREFORE, THIS EVENT WAS REASSESSED AS MDR REPORTABLE UNDER THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND THE OCTARAY MAPPING CATHETER. THE AWARENESS DATE FOR THE REPORTABLE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND AN OCTARAY MAPPING CATHETER IS 22-MAY-2024. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER¿ WAS REASSESSED TO A NOT REPORTABLE CONCOMITANT PRODUCT. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) ABLATION WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND AN OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. AFTER MAPPING IN THE RIGHT ATRIUM WITH THE OCTARAY MAPPING CATHETER, A TRANSSEPTAL PROCEDURE WAS PERFORMED. THE VIZIGO SHEATH AND OCTARAY MAPPING CATHETER WENT INTO THE LEFT ATRIUM TO MAP. THE OCTARA

  Patient problems: Cardiac Tamponade

  MAUDE report 19550866 ↗
• InjuryFeb 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE WITH AN OCTARAY CATHETER, THE PATIENT SUSTAINED A PERICARDIAL EFFUSION. THIS INJURY WAS DISCOVERED WHEN A BLOOD PRESSURE DROP WAS NOTICED IN THE PATIENT. THE INJURY WAS CONFIRMED VIA THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) SYSTEM WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. A PERICARDIOCENTESIS WAS PERFORMED FOR MEDICAL INTERVENTION WHICH RESULTED IN 300 MILLILITERS OF FLUID BEING REMOVED FROM THE PATIENT. THE PATIENT IS NOW STABLE. THE PHYSICIAN BELIEVES THE ICE CATHETER WENT INTO THE RIGHT ATRIAL APPENDAGE AND CAUSED A PERFORATION. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER INC. (BWI) PRODUCTS. PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS BWI PRODUCT MALFUNCTION AND PATIENT CONDITION (ANATOMY). PERICARDIOCENTESIS WAS PERFORMED. OUTCOME OF ADVERSE EVENT WAS FULLY RECOVERED. PATIENT STAYED OVERNIGHT AND WAS THEN DISCHARGED THE NEXT DAY. TRANSSEPTAL PUNCTURE

  Patient problems: Cardiac Tamponade

  MAUDE report 16416071 ↗
• InjuryFeb 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE WITH AN OCTARAY CATHETER, THE PATIENT SUSTAINED A PERICARDIAL EFFUSION. THIS INJURY WAS DISCOVERED WHEN A BLOOD PRESSURE DROP WAS NOTICED IN THE PATIENT. THE INJURY WAS CONFIRMED VIA THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) SYSTEM WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. A PERICARDIOCENTESIS WAS PERFORMED FOR MEDICAL INTERVENTION WHICH RESULTED IN 300 MILLILITERS OF FLUID BEING REMOVED FROM THE PATIENT. THE PATIENT IS NOW STABLE. THE PHYSICIAN BELIEVES THE ICE CATHETER WENT INTO THE RIGHT ATRIAL APPENDAGE AND CAUSED A PERFORATION. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER INC. (BWI) PRODUCTS. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS BWI PRODUCT MALFUNCTION AND PATIENT CONDITION (ANATOMY). PERICARDIOCENTESIS WAS PERFORMED. OUTCOME OF ADVERSE EVENT WAS FULLY RECOVERED. PATIENT STAYED OVERNIGHT AND WAS THEN DISCHARGED THE NEXT DAY. TRANSSEPTAL PUNCTURE

  Patient problems: Cardiac Tamponade

  MAUDE report 16391817 ↗