SOUNDSTARRecalls & reported problems across all models

We found 6 models of SOUNDSTAR by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 260 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2017 and Sep 1, 2026 — classified as 11 deaths, 115 injuries, 134 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (83 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SOUNDSTAR problems

SOUNDSTAR models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SOUNDSTAR 10439236

  Catheter, ultrasound, intravascular
  4 deaths107 reports
• SOUNDSTAR 10439011

  Catheter, ultrasound, intravascular
  2 deaths90 reports
• SOUNDSTAR 10439072

  Catheter, ultrasound, intravascular
  4 deaths29 reports
• SOUNDSTAR 10438577

  Catheter, ultrasound, intravascular
  1 death21 reports
• SOUNDSTAR SNDSTR10

  Catheter, ultrasound, intravascular
  9 reports
• SOUNDSTAR SNDSTR10G

  Catheter, ultrasound, intravascular
  4 reports

Recent SOUNDSTAR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an Atrial Tachycardia ablation procedure with a QDOT MICRO catheter and a SOUNDSTAR catheter and the patient experienced cardiac perforation and syncope which required pericardiocentesis.After the Atrial Tachycardia ablation with the QDOT catheter, a pericardial effusion was noticed. The patient had been stable during the entire procedure. Thirty-five minutes after the patient left the room post ablation, the patient had a drop in blood pressure and they became unconscious. It was unknown how the pericardial effusion was confirmed. The medical intervention provided was a pericardiocentesis and 180cc of fluid was removed. An additional 900 mL fluid was removed during the night after the procedure. Patient stayed in the hospital for two nights because the effusion grew. The patient was reported to be in stable condition.They found a trace pericardial effusion in the left ventricle before the procedure and when they checked on intracardiac echocardiogram after the procedure, the pericardial effusion was the same. The physician could not confirm what caused the pericardial effusion after the procedure but believed the SOUNDSTAR catheter may have

  Patient problems: Cardiac Perforation; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 50545889 ↗
• MalfunctionFeb 23, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER AND DURING THE OPERATION, THE ACOUSTIC IMAGE OF THE ULTRASOUND SYSTEM HAD POOR QUALITY OR THERE WERE ISSUES WITH THE VIDEO. 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 SOUNDSTAR MAGNETIC, TRANSDUCER, RECOGNITION, AND VISUALIZATION TEST WERE PERFORMED. THE VISUAL INSPECTION REVEALED THAT THE SHAFT WAS TORN WITH INTERNAL PARTS EXPOSED ON THE DEVICE. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24424095 ↗
• InjuryFeb 20, 2026Patient Device Interaction Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A NON-BWI CATHETER AND SOUNDSTAR CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DROPPED, AND PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS WITH A MODERATE AMOUNT OF BLOOD WITHDRAWN. THE PATIENT WAS STABLE ON TRANSFER TO ICU FOR FURTHER MONITORING. THE PHYSICIAN COMMENTED THAT EITHER THE PFA (PULSE FIELD ABLATION) APPLICATIONS IN THE SVC (SUPERIOR VENA CAVA) OR THE MANIPULATION OF THE SOUNDSTAR CATHETER MOST LIKELY CAUSED THE PERICARDIAL EFFUSION. THE REPORT INDICATED THAT THE PATIENT HAD AN ADVERSE EVENT/PERICARDIAL EFFUSION. POST COMPLETION OF PFA WITH THE BOSTON SCIENTIFIC FARAWAVE CATHETER THE PHYSICIAN ADVANCED THE CATHETER INTO THE SVC, AND SHORTLY AFTER APPLYING PFA TO THE SVC THE ANESTHESIOLOGIST REPORTED THAT THE PATIENT'S BLOOD PRESSURE HAD DROPPED. A PERICARDIAL EFFUSION WAS DISCOVERED USING INTRACARDIAC ECHO. PERICARDIOCENTESIS WAS COMPLETED AND A MODERATE AMOUNT OF BLOOD WAS WITHDRAWN. THE PHYSICIAN COMMENTED THAT EITHER THE PFA APPLICATIONS IN THE SVC OR THE MANIPULATION OF THE SOUNDSTAR CATHETER MOST LIKELY CAUSED THE PERICARDIAL EFFUSION. THE PRODUCTS USED DURING THE PROCEDURE WERE A 10FR GE SOUNDSTAR CAT

  Patient problems: Cardiac Tamponade

  MAUDE report 24408059 ↗
• MalfunctionJan 22, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER WITH WHEN THE CATHETER WAS ABOUT TO BE OPENED THE MEDICAL TEAM SAW THAT THE PACKAGING WAS COMPROMISED WITH A CUT IN IT. THEY OPENED ANOTHER CATHETER AND THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152482 ↗
• MalfunctionJan 16, 2026Communication or Transmission Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER AND THE CATHETER WAS NOT RECOGNIZED BY THE S70 ULTRASOUND SYSTEM WHEN IT WAS CONNECTED TO THE PIU ON THE CARTO 3 SYSTEM. CHANGING OUT THE ULTRASOUND SYSTEM AND THE SWIFTLINK CABLE DID NOT RESOLVE THE ISSUE. CONNECTING A DUMMY CATHETER RESOLVED THE ISSUE. THEY THEN REPLACED THE SOUNDSTAR CATHETER AND THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS THEN CONTINUED. 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 SOUNDSTAR MAGNETIC, RECOGNITION, AND VISUALIZATION TESTING OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED TWO CUTS ON THE SHAFT AND INTERNAL COMPONENTS EXPOSED. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096663 ↗
• MalfunctionJan 12, 2026Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8F G CATHETER AND AFTER THE KNOB IS ROTATED, IT CANNOT AUTOMATICALLY RETURN TO THE INITIAL POSITION AND NEEDED TO BE CORRECTED MANUALLY. THE CURVE WAS NOT STRAIGHTENING ITSELF WHEN RELEASING THE LOCKING MECHANISM. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24044642 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER AND A SOUNDSTAR CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED DRAINAGE AND PROLONGED HOSPITALIZATION. DURING THE PROCEDURE, CARDIAC TAMPONADE OCCURRED. DURING POST-MAPPING, THE CARTO 3 SCREEN FROZE AND WAS FORCED TO RESTART. THE FORCED RESTART OCCURRED DURING POST-MAPPING. WHILE THE SYSTEM WAS BEING RESTORED, THE PATIENT¿S BLOOD PRESSURE DROPPED. INTRACARDIAC ECHOCARDIOGRAPHY WAS PERFORMED AND REVEALED THE PERICARDIAL EFFUSION. DRAINAGE WAS PERFORMED. A DECREASE IN THE PERICARDIAL EFFUSION AND STABILIZATION OF THE PATIENT¿S VITALS WAS CONFIRMED, AND THE PATIENT WAS OBSERVED IN THE INTENSIVE CARE UNIT. AFTER THE CARTO 3 WORKSTATION (WS) MAIN POWER WAS FORCIBLY TERMINATED, THE WS WAS REBOOTED AND THE SYSTEM WAS SUBSEQUENTLY RESTORED. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS SERIOUS. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS AS A RESULT OF BLOOD-GAS ANALYSIS, THE ACCUMULATED BLOOD WAS VENOUS. EXTENDED HOSPITALIZATION WAS REPORTED. THE VARIPULSE CATHETER, WHICH HAD BEEN MANEUVERED IN THE LEFT ATRIUM, WAS UNLIKELY TO

  Patient problems: Cardiac Tamponade

  MAUDE report 23873725 ↗
• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION TREATED WITH PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT DURING AN AFIB CASE WITH A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. THE PHYSICIAN WAS CHECKING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WITH THE SOUNDSTAR CATHETER AND A PERICARDIAL EFFUSION WAS NOTICED. THE PERICARDIAL EFFUSION WAS CONFIRMED VIA ECHO. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS; IT IS UNKNOWN HOW MUCH FLUID WAS REMOVED. THE PATIENT WAS IN STABLE CONDITION. THE PHYSICIAN BELIEVES THAT THE SOUNDSTAR CATHETER MAY HAVE CAUSED A PERFORATION, AS THE PHYSICIAN WAS HAVING DIFFICULTY ACCESSING THE VENTRICLE, BUT THE INFORMATION HAS NOT YET BEEN CONFIRMED. A NEW VARIPULSE CATHETER WAS OPENED FOR THE PROCEDURE, BUT IT WAS NEVER INSERTED INTO THE PATIENT. A WEBSTER CS CATHETER AND A SOUNDSTAR CATHETER WERE THE ONLY BWI DEVICES INSIDE THE PATIENT FOR THE PROCEDURE. NO ABLATION HAD BEEN PERFORMED FOR THE PROCEDURE. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PATIENT

  Patient problems: Cardiac Perforation

  MAUDE report 23824162 ↗
• MalfunctionDec 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SOUNDSTAR CATHETER. THE SOUNDSTAR CATHETER HAD PLASTIC MATERIAL ATTACHED TO THE HANDLE IN MULTIPLE LOCATIONS WHERE IT SHOULD NOT BE, RIGHT OUT OF THE PACKAGE. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOTICED BEFORE USE ON THE PATIENT. NO PICTURE AVAILABLE. MATERIAL OBSERVED WAS EMBEDDED TO THE DEVICE. CONFIRMED THAT THE SECTION OF THE CATHETER THAT THE ISSUE WAS FOUND WAS THE HANDLE. NO PHYSICAL DAMAGE NOTED. JUST THE FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23805188 ↗
• MalfunctionDec 5, 2025Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR AND SOME "TAGADERM" WAS ON THE TIP OF THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THAT SOME "TAGADERM" WAS ON THE TIP OF THE CATHETER. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. REPLACEMENT CATHETER REQUESTED. THE CATHETER WAS BRAND NEW AND NOT REPROCESSED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724450 ↗
• MalfunctionDec 4, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR CATHETER WHICH HAD THE DEFLECTION MECHANISM "STUCK." THE CALLER REPLACED THE SOUNDSTAR® CATHETER AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS ABLE TO CONTINUE WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723508 ↗
• 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 ↗
• MalfunctionOct 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR AND THERE WAS DEBRIS ON THE INSIDE OF THE CATHETER BOX. THE ISSUE WAS DISCOVERED WHEN THEY OPENED THE CATHETER. THE CATHETER WAS BRAND NEW FROM BWI BOX PACKAGING. THEY DID NOT FEEL COMFORTABLE USING THE CATHETER, SO THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411290 ↗
• MalfunctionOct 20, 2025Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SOUNDSTAR CATHETER AND A STICKY ADHESIVE SUBSTANCE WAS ON THE CATHETER. THEY OPENED AND REMOVED A SOUNDSTAR CATHETER FROM ITS PACKAGING AND NOTICED A "STICKY ADHESIVE" SUBSTANCE WAS ON THE CATHETER. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE CALLER NOTED THAT IT WAS A BRAND NEW CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO PATIENT CONSEQUENCE REPORTED. THE NGEN¿ GENERATOR WAS IN USE. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE ON THE SOUNDSTAR CATHETER WAS NOTICED BEFORE USE, AS SOON AS THE CATHETER WAS REMOVED FROM THE PACKAGING AND THE CATHETER WAS NOT USED ON THE PATIENT. THE MATERIAL LOOKED LIKE REMNANTS OF TAPE, IT WAS NOT MOVING AND LOOKED LIKE WHITE/TRANSPARENT STICKY ADHESIVE. THEY DO NOT HAVE THE PACKAGING BUT THEY DO HAVE THE CATHETER AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344010 ↗
• MalfunctionOct 16, 2025Material Twisted/Bent; Mechanical Jam; Positioning Problem; Material Twisted/Bent; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SOUNDSTAR ECO AND THE DEFLECTION MECHANISM BECAME STUCK. AFTER INSERTING THE CATHETER INTO THE CARDIAC CAVITY AND PERFORMING BROCKENBROUGH, APPROXIMATELY ONE HOUR AFTER USING IT IN THE LEFT ATRIUM (TO CONFIRM THE SITE FOR ABLATION WITH FARAPULSE) THE PHYSICIAN REPORTED THAT ITS BEHAVIOR WAS DIFFERENT FROM USUAL. AFTER BENDING THE SOUNDSTAR ECO CATHETER ON THE P SIDE, IT DID NOT RETURN TO THE CENTER AND REMAINED UNABLE TO BECOME FLAT. IT APPEARED TO HAVE DEVELOPED A BEND OR KINK, AND EVEN WHEN BENT ON THE A SIDE, THE CATHETER DID NOT STRAIGHTEN OUT. SINCE IT WAS JUST BEFORE THE END OF THE PROCEDURE, THE PHYSICIAN INSTRUCTED NOT TO REPLACE THE CATHETER, AND THE PROCEDURE WAS COMPLETED AS IT WAS. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED INDICATED THE KNOB WAS ABLE TO BE TURNED AND/OR PUSHED UP AND DOWN BUT THE CATHETER WAS STUCK. THE CATHETER COULD NOT BE FLATTENED, EVENT WHEN SHAPED BY HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318983 ↗

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