NuVision ICE Catheter FG10593Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00860005688104), received between Aug 19, 2022 and Jan 6, 2026 — classified as 1 death, 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WAS PREPARED FOR A LEFT ATRIAL APPENDAGE OCCLUSION PROCEDURE WITH A NUVISION ICE CATHETER AND THEY SUFFERED A PERICARDIAL EFFUSION. THIS WAS DISCOVERED WHEN THE PATIENT BECAME HYPOTENSIVE. ICE (INTRACARDIAC ECHOCARDIOGRAPHY) IMAGING WITH A NUVISION CATHETER WAS PERFORMED, AND THE EFFUSION WAS SEEN. A PERICARDIOCENTESIS WAS PERFORMED. THE PROCEDURE WAS CANCELLED. THE LAST KNOWN PATIENT STATUS WAS STABLE. CARTO SYSTEM OR JNJ GENERATOR WERE NOT IN USE. THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN THOUGHT THE EFFUSION MAY BE CAUSED BY ICE.

  Patient problems: Cardiac Tamponade

  MAUDE report 23978099 ↗
• InjuryOct 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A WATCHMAN PROCEDURE, WHILE DOING A DEMO OF THE NUVISION ULTRASOUND CATHETER, THE PATIENT EXPERIENCED CARDIAC PERFORATION, AND THE SURGERY TEAM WAS CALLED IN FOR A PERICARDIAL WINDOW. THE PATIENT WAS STABLE. IT WAS REPORTED THAT WHILE THEY WERE DOING A DEMO WITH A NUVISION ULTRASOUND CATHETER, THEY NOTICED A BASELINE EFFUSION IN THE PATIENT AND THE PHYSICIAN DECIDED TO PROCEED WITH THE CASE. THEY CROSSED TRANSSEPTAL "FINE" WITH THE NUVISION¿ ULTRASOUND CATHETER INTO THE LEFT ATRIUM. THE NUVISION ULTRASOUND CATHETER WAS USED FOR IMAGING TO SIZE THE WATCHMAN. THEY NOTICED THE APPENDAGE WAS LARGE AND "WEIRD." THEY PROCEEDED TO PLACE THE WATCHMAN SHEETS AND WHEN POSITIONING IT, THE WATCHMAN REPRESENTATIVE STATED THAT IT WAS TOO DEEP IN THE APPENDAGE, AND THEY ALL AGREED. THE PHYSICIAN PULLED THE SHEATH BACK THE MOST MINIMAL AMOUNT AND DEPLOYED THE WATCHMAN. THE PATIENT¿S BLOOD PRESSURE "PLUMMETED", THE PHYSICIAN RETRACTED THE NUVISION ULTRASOUND CATHETER OUT OF THE HEART, TURNED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), LOOKED AND NOTICED A HUGE EFFUSION. THE WATCHMAN WAS DEPLOYED INTO THE PERICARDIUM, AND THE INJURY WAS A LARGE CARDIAC PERFORATION, THAT WAS DISCOVERED BY THE DRO

  Patient problems: Cardiac Perforation

  MAUDE report 23316944 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WATCHMAN PROCEDURE WITH A NUVISION INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER AND THE DISTAL TIP OF THE CATHETER CAME APART FROM THE SHAFT OF THE CATHETER. THE CATHETER WAS REPLACED AND THE CASE CONTINUED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909243 ↗
• DeathAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE WHILE USING A NUVISION ICE CATHETER, THE PATIENT EXPERIENCED PRESSURE DROP, PERICARDIAL EFFUSION, AND CPR WAS PERFORMED--AFTER WHICH, THE PATIENT PASSED AWAY. IT WAS REPORTED THAT DURING A WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY CROSSING THE SEPTUM WITH THE NUVISION CATHETER AND AFTER APPROXIMATELY 40 MINUTES, THE PATIENT HAD A PRESSURE DROP. IT WAS OBSERVED BY ULTRASOUND THAT THE PATIENT HAD A LARGE PERICARDIAL EFFUSION AROUND THE RIGHT ATRIUM AND RIGHT VENTRICLE. THEY PERFORMED A PERICARDIAL EFFUSION AND CPR. OVER 2 LITERS WAS REMOVED FROM THE PERICARDIAL SPACE. SURGICAL INTERVENTION WAS CONSIDERED, BUT THE FAMILY OF THE PATIENT DECLINED AS THE PATIENT WAS A DNR (DO NOT RESUSCITATE). THE PATIENT THEN PASSED AWAY. INFORMATION RECEIVED INDICATED THE PHYSICIAN¿S OPINION ON THE CAUSE OF DEATH WAS THAT THE NUVISION CATHETER PERFORATED THE RIGHT ATRIUM.

  Patient problems: Cardiac Arrest; Cardiac Perforation

  MAUDE report 22689717 ↗
• InjuryJun 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AVRT (ATRIOVENTRICULAR REENTRANT TACHYCARDIA ) /WPW (WOLFF-PARKINSON-WHITE) ABLATION WITH A NUVISION ICE CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. FIRST, IT WAS REPORTED THAT "PROBE WAS NOT SUPPORTED" ERROR WAS DISPLAYED ON THE S70 ULTRASOUND MACHINE AND THE CATHETER DISAPPEARED WHEN THE CATHETER CONNECTED. THE CATHETER TO ULTRASOUND MACHINE WAS RESEATED WITHOUT RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. IT WAS ALSO REPORTED THAT ON (B)(6) 2025 DURING A WPW CASE, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. AFTER THE PHYSICIAN HAD GONE TRANSSEPTAL WITH A NUVISION CATHETER, THE PHYSICIAN NOTICED THERE WAS A LOT OF FLUIDS IN THE RIGHT VENTRICLE. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH ICE (INTRACARDIAC ECHOCARDIOGRAPHY). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTISIS AND 300 CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS RECOVERING IN THE ICU (INTENSIVE CARE UNIT). THE PHYSICIAN STATED THE INJURY MIGHT'VE CAUSED BY ICE AFTER THE TRANSSEPTAL.

  Patient problems: Cardiac Tamponade

  MAUDE report 22169481 ↗
• MalfunctionJun 6, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE OCCLUSION PROCEDURE WITH A NUVISION INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER AND THE CATHETER KEPT HEATING UP WHERE THE ULS SYSTEM KEPT SHUTTING OFF/ FREEZING DUE TO THE CATHETER HEATING INSIDE THE PATIENT BODY. THE FREEZING OF ULS SYSTEM IS A SAFETY MECHANISM BY ULS SYSTEM. ALSO, THE ULS SYSTEM HAS HEAT INDEX WHERE NUVISION CATHETER REACHED 43 DEGREES. THE PATIENT AND THE DOCTOR WERE SAFE, AND NO COMPLICATIONS NOTED. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE CASE WAS CONTINUED, AND NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161271 ↗
• MalfunctionApr 28, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN WATCHMAN LAAO (LEFT ATRIAL APPENDAGE OCCLUSION) ABLATION PROCEDURE WITH NUVISION ICE CATHETER, 10F AND THE CATHETER WAS OVERHEATING AND STOPPED WORKING. THE MEDICAL TEAM EXCHANGED THE CATHETER. THE PROCEDURE CONTINUED. NO FURTHER DETAILS WERE PROVIDED REGARDING THE CIRCUMSTANCES OF THE OVERHEATING OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921724 ↗
• InjuryJan 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE OCCLUSION PROCEDURE WITH A NUVISION ICE CATHETER, 10F AND THE PATIENT EXPERIENCED VASCULAR PSEUDOANEURYSM/DISSECTION THAT REQUIRED SURGICAL INTERVENTION. IT WAS REPORTED THAT UPON CONNECTION OF THE CATHETER TO THE ULTRASOUND SYSTEM, AN ERROR BOX WAS DISPLAYED ON THE ULTRASOUND SYSTEM WITH THE FOLLOWING MESSAGE: "PROBE 4D ICE TEST DID NOT PASS." THE ERROR CLEARED ON ITS OWN. THE PROCEDURE CONTINUED. IT WAS ALSO REPORTED THAT A PERFORATION TO THE PATIENT'S VASCULATURE OCCURRED DURING THE PROCEDURE WHILE GAINING RIGHT LEG ACCESS. ONCE THE MEDICAL TEAM HAD ACCESS AND THE NUVISION CATHETER WAS PLACED THROUGH THE SHEATH AND THE RIGHT LEG, THE PHYSICIAN HAD TROUBLE ADVANCING THE NUVISION CATHETER THROUGH THE INFERIOR VENA CAVA (IVC). IT WAS BELIEVED AT FIRST THAT IT WAS DUE TO TORTUROUS VESSELS AND THAT AT ONE POINT THEY BELIEVED THEY HAD REACHED A BRANCH. THERE WAS SOME RESISTANCE WITH THE NUVISION CATHETER BUT THE PHYSICIAN DID NOT FORCE THE CATHETER. ONCE THE NUVISION CATHETER WAS IN THE HEART, IT WAS NOTICED THAT IT DID NOT LOOK RIGHT ON THE ULTRASOUND SYSTEM. THE NUVISION CATHETER DISPLAYED ON THE ULTRASOUND SYSTEM DID

  Patient problems: Perforation of Vessels; Pseudoaneurysm

  MAUDE report 21143615 ↗
• MalfunctionNov 27, 2024Display or Visual Feedback Problem; Material Twisted/Bent; Display or Visual Feedback Problem; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) WATCHMAN ABLATION PROCEDURE WITH A NUVISION ICE CATHETER, 10F AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A KINK AND A BREAKAGE ON THE TIP WITH REDDISH BROWN MATERIAL INSIDE. DURING THE PROCEDURE, AFTER INSERTION THERE WERE BRIGHT LINES AT THE TOP OF THE ULTRASOUND SCREEN. THE CATHETER CABLE WAS RESEATED WITHOUT RESOLUTION. THE CALLER STATED THAT THE ULTRASOUND MACHINE KEPT FREEZING. WHEN THE CATHETER WAS STUDIED UNDER FLUORO, THE TIP OF THE CATHETER WAS BENT. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE CALLER CONFIRMED THAT THE CATHETER DID NOT APPEAR BENT WHEN REMOVED FROM THE STERILE PACKAGING. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20794843 ↗
• MalfunctionNov 14, 2024Overheating of Device; Communication or Transmission Problem; Overheating of Device; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) ABLATION PROCEDURE WITH A NUVISION ICE CATHETER, 10F AND THE DEVICE WAS FREQUENTLY OVERHEATING. AS A RESULT THE GE P95 ULTRASOUND SYSTEM WOULD FREEZE ITSELF. THERE WAS NO VISIBLE SMOKE OR FLAMES. NO PART OF THE SYSTEM MELTED OR CARBONIZED. THE CATHETER WAS EXCHANGED TO CONTINUE THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20688563 ↗
• MalfunctionNov 1, 2024

  ERROR CODE " THE PROBE MAY HAVE A TECHNICAL ISSUE." PLEASE RECONNECT AND RESELECT PROBE - NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586646 ↗
• MalfunctionAug 22, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NUVISION ICE CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A BREAKAGE AT THE TIP. INITIALLY, IT WAS REPORTED THAT THE CATHETER STARTED FLICKERING AND "STROBING" WITH BRIGHT LINES ACROSS THE SECTOR ON THE E95 ULTRASOUND MACHINE. THE REPORTER TRIED RESEATING THE CATHETER FROM THE BASE WITH NO RESOLUTION. THEY ALSO TRIED CONNECTING THE CATHETER TO ALL THREE PORTS ON THE ULTRASOUND MACHINE WITH NO RESOLUTION. THEY THEN SWITCHED THE CATHETER TO AN ACUNAV CATHETER TO CONTINUE THE PROCEDURE. REPLACEMENT CATHETER REQUESTED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. IT WAS ALSO REPORTED THAT THIS WAS A PATENT FORAMEN OVALE (PFO) CLOSURE PROCEDURE WITH ABBOTT'S AMPLATZER¿ OCCLUDERS. THE VISUALIZATION ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 24-JUL-2024, THERE WAS A BREAKAGE AT THE TIP AND CRACK OF THE ADHESIVE INSIDE WITH REDDISH AND INTERNAL PARTS EXPOSED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031471 ↗
• MalfunctionJul 18, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A NUVISIONTM ICE CATHETER, 10F AND POST-PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A BREAKAGE IN THE SHAFT WITH BRAID EXPOSURE AND A CRACK OF THE ADHESIVE INSIDE. NO INTERNAL PARTS WERE EXPOSED. DURING THE PROCEDURE, THE CARTO 3 SYSTEM AND THE ULTRASOUND SYSTEM WAS NOT DISPLAYING AN ULTRASOUND IMAGE. THE TECH RESEATED ALL ULTRASOUND INTERFACE CABLES WITHOUT RESOLUTION. THEY THEN EXCHANGED THE ULTRASOUND CATHETER (NUVISIONTM ICE CATHETER, 10F) AND THE ISSUE RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19774359 ↗
• MalfunctionJul 1, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE GTIN INFORMATION ON THE LABEL OF THE NUVISIONTM ICE CATHETER, 10F DOES NOT MATCH PRODUCT INFORMATION REGISTERED UNDER GUIDID WEBSITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645813 ↗
• MalfunctionJun 27, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE GTIN INFORMATION ON THE LABEL OF THE NUVISION ICE CATHETER, 10F DOES NOT MATCH PRODUCT INFORMATION REGISTERED UNDER GUIDID WEBSITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629930 ↗
• MalfunctionJun 18, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE GTIN INFORMATION ON THE LABEL OF THE NUVISIONTM ICE CATHETER, 10F DOES NOT MATCH PRODUCT INFORMATION REGISTERED UNDER GUIDID WEBSITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564043 ↗
• MalfunctionAug 19, 2022Break; Display or Visual Feedback Problem; Break; Display or Visual Feedback Problem

  A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A NUVISION ICE CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED AN EXPOSED BRAID WIRE WAS NOTED APPROXIMATELY 11.2 CM FROM THE DISTAL END OF THE DEVICE. THE FINDING WAS IDENTIFIED ON (B)(6) 2022. DURING THE PROCEDURE, THE CARTO 3 SYSTEM AND ULTRASOUND SYSTEM WERE DISPLAYING POOR IMAGE QUALITY WHEN THE NUVISION CATHETER WAS CONNECTED TO THE ULTRASOUND MACHINE. THE MEDICAL TEAM REPLACED THE CATHETER, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. THE IMAGE QUALITY ISSUE IS NOT MDR-REPORTABLE. THE EXPOSED BRAID WIRE IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262260 ↗