SOUNDSTAR SNDSTR10GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835000153), received between Sep 27, 2023 and Feb 23, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryOct 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB)-PERSISTENT ABLATION PROCEDURE THAT INCLUDED A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PROLONGED HOSPITALIZATION. TWO WEEKS AFTER AN AFIB-PERSISTENT CASE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS ADMITTED FOR A CARDIAC TAMPONADE. THE PATIENT HAD COME BACK TO THE HOSPITAL BEFORE COMPLAINING OF PERICARDITIS ACCORDING TO THE PHYSICIAN. THEY ORDERED AN ECHOCARDIOGRAM (ECHO) AND IT WAS CLEAR AND THE PATIENT WAS SENT HOME. THE PATIENT RETURNED COMPLAINING OF MORE CHEST PAIN AND THEY DID A TRANSTHORACIC ECHO AND A CARDIAC TAMPONADE WAS SHOWN. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 1 LITER OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS ALSO REPORTED THAT THE PATIENT IS DIABETIC AND ON DIALYSIS. ON THE DAY OF THE PROCEDURE, THE INTERNATIONAL NORMALISED RATIO (INR) WAS 2.3. ON THE DAY WHEN THE PATIENT CAME INTO THE HOSPITAL FOR THE SAME ISSUE, THE INR WAS 3.1 AND YESTERDAY, AFTER GETTING ADMITTED, THE INR WAS 3.6. THEY ALSO SAW A LITTLE FIBROSIS IN THE INTERIOR PORTION OF THE INTRAVENOUS (IV), SO T

  Patient problems: Cardiac Tamponade

  MAUDE report 17852102 ↗
• InjurySep 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB)-PERSISTENT ABLATION PROCEDURE THAT INCLUDED A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PROLONGED HOSPITALIZATION. TWO WEEKS AFTER AN AFIB-PERSISTENT CASE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS ADMITTED FOR A CARDIAC TAMPONADE. THE PATIENT HAD COME BACK TO THE HOSPITAL BEFORE COMPLAINING OF PERICARDITIS ACCORDING TO THE PHYSICIAN. THEY ORDERED AN ECHOCARDIOGRAM (ECHO) AND IT WAS CLEAR AND THE PATIENT WAS SENT HOME. THE PATIENT RETURNED COMPLAINING OF MORE CHEST PAIN AND THEY DID A TRANSTHORACIC ECHO AND A CARDIAC TAMPONADE WAS SHOWN. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 1 LITER OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. IT WAS ALSO REPORTED THAT THE PATIENT IS DIABETIC AND ON DIALYSIS. ON THE DAY OF THE PROCEDURE, THE INTERNATIONAL NORMALISED RATIO (INR) WAS 2.3. ON THE DAY WHEN THE PATIENT CAME INTO THE HOSPITAL FOR THE SAME ISSUE, THE INR WAS 3.1 AND YESTERDAY, AFTER GETTING ADMITTED, THE INR WAS 3.6. THEY ALSO SAW A LITTLE FIBROSIS IN THE INTERIOR PORTION OF THE INTRAVENOUS (IV), SO T

  Patient problems: Cardiac Perforation

  MAUDE report 17826019 ↗