VeriSight Pro Intracardiac Echocariography Catheter VSICE3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00845225003036), received between May 20, 2024 and Dec 17, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 1, 2025Class IIOpen, Classified

   Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

   Z-1660-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERISIGHT PRO CATHETER WAS USED IN AN INFERIOR VENA CAVA FILTER (IVCF) PROCEDURE. PRIOR TO USE OF THE CATHETER, A NON-PHILIPS INTRODUCER SHEATH WAS INSERTED INTO THE IVC. WHILE ADVANCING THE CATHETER IN THE INTRODUCER SHEATH, AN IVC PERFORATION WAS NOTED. IT WAS SUSPECTED THAT THE INTRODUCER SHEATH DID SOME INITIAL DAMAGE TO THE IVC; HOWEVER, NO SYMPTOMS WERE NOTED AFTER SHEATH ADVANCEMENT. THE IVC WAS REPAIRED WITH AAA ENDOPROSTHESIS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE VERISIGHT WAS IN USE WHEN A PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE VERISIGHT.

  Patient problems: Perforation of Vessels

  MAUDE report 23832425 ↗
• MalfunctionOct 28, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT A VERISIGHT PRO CATHETER WAS USED IN A VENOUS STRUCTURAL HEART PROCEDURE. WHEN TESTING THE CATHETER IN SALINE, AN 006 ERROR MESSAGE APPEARED. THE CATHETER WAS UNPLUGGED, AND THE PHILIPS EPIQ SYSTEM WAS REBOOTED. WHEN THE SYSTEM POWERED BACK ON, AN 005 ERROR MESSAGE APPEARED; THEREFORE, OTHER PROBES WERE ATTEMPTED BUT COULD NOT BE USED. THE OVERALL CASE WAS ABORTED AND IT IS UNKNOWN IF THE PATIENT WILL BE RESCHEDULED FOR A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CATHETER COULD NOT BE USED, RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408322 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERISIGHT CATHETER WAS USED IN A VENOUS STRUCTURAL HEART PROCEDURE. DURING USE, THE CATHETER WAS POSITIONED IN THE LEFT ATRIUM, WHEN THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHICH LED TO A CARDIAC TAMPONADE. THE CATHETER WAS RECAPTURED AND REMOVED ALONG WITH THE WATCHMAN SHEATH. THEN, A PERICARDIOCENTESIS WAS PERFORMED, PATIENT WAS INTUBATED, FOLLOWED BY SURGICAL INTERVENTION (THORACOTOMY AND LAA LIGATION/REPAIR). THE PROCEDURE WAS COMPLETED AND PATIENT IS IN GOOD CONDITION. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE VERISIGHT WAS IN USE WHEN THE PATIENT EXPERIENCED A CARDIAC TAMPONADE, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE VERISIGHT CATHETER.

  Patient problems: Cardiac Tamponade

  MAUDE report 23067763 ↗
• MalfunctionJul 28, 2025Device Displays Incorrect Message

  DURING PREP, THE VERSIGHT ICE CATHETER DISPLAYED AN ERROR MESSAGE. THE CATHETER WAS REMOVED AND REPLACED AND, WITH NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR CATHETER, VERISIGHT PRO ICE CATHETER, INTRACARDIAC AND INTRA-LUMINAL VISUALIZATION (PER SITE REPORTER). MFG [MANUFACTURER] NOTIFIED BY SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22622807 ↗
• MalfunctionFeb 10, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A VERISIGHT PRO CATHETER WAS USED IN A THERAPEUTIC TRICUSPID REPAIR PROCEDURE. THE CATHETER WAS ADVANCED AND PLACED IN A FLEXION POSITION. AFTER TREATMENT, THE STEERING WHEELS AND CLUTCH KNOB WERE POSITIONED BACK TO NEUTRAL, BUT THE ARTICULATE SEGMENT WAS STUCK IN A POSTERIOR FLEXION POSITION (SLIGHT BACK BEND). HOWEVER, THERE WAS NO DIFFICULTY REMOVING THE CATHETER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE VERISIGHT GOT STUCK IN AN ARTICULATED POSITION. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351321 ↗
• MalfunctionOct 16, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT A VERISIGHT CATHETER WAS USED IN A THERAPEUTIC EP STRUCTURAL HEART PROCEDURE TO GUIDE AN INTRAPROCEDURAL IMPLANT FOR LEFT ATRIAL APPENDAGE CLOSURE. DURING USE, WHEN SWITCHING BACK FROM THE X5-1C TRANSTHORACIC PROBE TO VERISIGHT, THE IMAGE BECAME BLURRY AND UNUSABLE. THE PROCEDURE WAS POSTPONED AND WILL BE RESCHEDULED WITH USE OF GENERAL ANESTHESIA AND TEE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE TO THE POOR IMAGE QUALITY, RESULTING IN A DELAY OF PROCEDURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467567 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERISIGHT CATHETER WAS USED IN A THERAPEUTIC EP STRUCTURAL HEART PROCEDURE. THE CATHETER WAS DELIVERED OVER A NON-PHILIPS GUIDEWIRE THAT WAS PLACED NEAR THE LEFT ATRIAL APPENDAGE (LAA). AFTER THE ATRIAL SEPTUM WAS DILATED, THE CATHETER WAS ADVANCED TO THE LEFT ATRIUM WHEN THE PATIENT¿S BLOOD PRESSURE DROPPED. AN EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), AND A MICROSCOPIC PERFORATION WAS NOTED IN THE LAA. THE PATIENT WAS TRANSFERRED TO THE OR TO SURGICALLY REPAIR THE PERFORATION. THIS ADVERSE EVENT IS BEING SUBMITTED FOR THE VERISIGHT CATHETER, IN USE IN THE AREA WHEN A PERFORATION OCCURRED, REQUIRING SURGICAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE VERISIGHT CATHETER DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 19986574 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VERISIGHT PRO (ICE) CATHETER WAS USED ON A PATIENT WITH CHRONIC ANTICOAGULATION AND WITH AMYLOID ANGIOPATHY SCHEDULED FOR LEFT ATRIAL APPENDAGE (LAA) CLOSURE TO AVOID LONG TERM ANTICOAGULATION. ICE WAS INSERTED VIA LEFT FEMORAL APPROACH, AND ANTICOAGULATION WITH HEPARIN WAS STARTED. BASED ON PREOP CT SCANS, A LOWER SEPTAL STICK WAS DECIDED BECAUSE IT WOULD HAVE BEEN THE BEST ANGLE TO DELIVER THE WATCHMAN DEVICE INTO THE LAA. TRANSEPTAL WAS UNEVENTFUL, THE WIRE CROSSED, AND THE HOLE WAS DILATED. THE ICE WAS DIFFICULT TO GET ACROSS THE INTERATRIAL SEPTUM DUE TO TORTUOSITY, AND AFTER MULTIPLE ATTEMPTS, A SECOND INTERATRIAL STICK WAS PERFORMED THAT WAS PLACED HIGHER. A ¿SWIRLING¿ IN THE DISTAL FIELD OF THE ICE WAS NOTED, BUT COULD NOT EXACTLY BE DETERMINED. THE TRANSEPTAL WAS PERFORMED, WIRE WAS PLACED IN THE LEFT ATRIUM, AND THE WATCHMAN WAS DELIVERED IN THE LAA. WHEN THE TEE WAS TURNED ON TO CHECK THE DEVICE POSITIONING, AT THAT POINT IT WAS CLEAR THAT THE ¿SWIRLING¿ WAS IN FACT A LEFT ATRIAL INTRAMURAL HEMATOMA, WHICH MEASURED 6.4 X 3.7 CM. HOWEVER, IT DID NOT INTERFERE WITH MITRAL VALVE FUNCTION. DURING THE SECOND TRANSEPTAL AND POSITIONING OF THE WATCHMAN, T

  Patient problems: Hematoma; Pericardial Effusion

  MAUDE report 19356193 ↗