CARTO VIZIGORecalls & reported problems across all models

We found 2 models of CARTO VIZIGO by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 349 adverse event reports in the FDA's MAUDE database, received between Apr 30, 2024 and Sep 30, 2026 — classified as 2 deaths, 24 injuries, 323 malfunctions.

The most frequently reported specific device problem is “Backflow” (138 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 CARTO VIZIGO problems

CARTO VIZIGO models

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

• CARTO VIZIGO D138504

  Introducer, catheter
  2 deaths288 reports
• CARTO VIZIGO D138505

  Introducer, catheter
  61 reports

Recent CARTO VIZIGO adverse event reports

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

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951523 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak

  It was reported that a patient underwent a cardiac ablation procedure with CARTO VIZIGO and there was damage to the orange valve of the VIZIGO. It was noted during post mapping acquisition. It was determined that air would not be drawn in because continuous perfusion saline was flowing back from the valve. The post-map was completed as quickly as possible and the procedure was completed. There was no patient consequence.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928968 ↗
• MalfunctionSep 28, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920066 ↗
• MalfunctionSep 25, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905511 ↗
• InjurySep 25, 2026Positioning Problem; Patient Device Interaction Problem

  It was reported that a patient underwent an Atrial Fibrillation (AFib) ablation procedure with a VARIPULSE¿ Bi-Directional Catheter and the patient experienced a cardiac perforation with required surgical intervention.Approximately 20 minutes after initiation of pulmonary vein isolation and after approximately 20 ablations had been performed, the patient's blood pressure suddenly decreased, and pericardial effusion was confirmed by echocardiography. Thoracotomy was performed, and blood transfusion was administered. The patient's blood pressure returned to normal with extracorporeal membrane oxygenation (ECMO). A perforation was located at the tip of the left atrial appendage. The patient required extended hospitalization. The patient¿s condition has improved.Transseptal puncture was performed with Scooper RF needle 89 cm (RFN-89Dnx).Physician's assessment of health hazard is serious. Physician's comment regarding relationship between the event and the product is that there was an occasion when the VIZIGO lost deflection. At that time, it was suspected that the VARIPULSE Catheter may have been caught on something inside the cardiac chamber. While the VIZIGO sheath was in a straight

  Patient problems: Cardiac Perforation

  MAUDE report 50900049 ↗
• MalfunctionSep 25, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898145 ↗
• MalfunctionAug 22, 2026Difficult to Advance; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383936 ↗
• MalfunctionAug 10, 2026Material Separation

  It was reported that a patient underwent an Atrial Fibrillation (AFib) procedure with two CARTO VIZIGO sheaths and hemostatic valve dislodgement issues were observed.Dislodgement of the hemostatic valve was observed during setup. The sheath was replaced. However, the hemostatic valve of the new sheath was also dislodged and it was a product of the same lot. The issue was resolved by replacing the CARTO VIZIGO sheath of a different lot. There was no patient consequence reported.Additional information was received on 23-Jul-2026. The sheath was not used on the patient. No needle was involved in the alleged event.Additional information was received on 26-Jul-2026. The hemostatic valve was dislodged inside the hub. The brim cap was not detached from the sheath. The hub was not detached from the sheath.The two CARTO VIZIGO sheaths with the hemostatic valve dislodgement issues were assessed as MDR reportable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201006 ↗
• MalfunctionAug 5, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136744 ↗
• InjuryJul 17, 2026Material Separation; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND THE PATIENT EXPERIENCED AIR EMBOLISM THAT REQUIRED ASPIRATION WITH A PIGTAIL CATHETER. AFTER PERFORMING PRE-MAPPING OF LEFT ATRIUM, VIZIGO PRIMING WAS PERFORMED AND AIR WAS CONFIRMED TO HAVE BEEN ASPIRATED INTO THE SYRINGE. NO SPECIFIC ERROR WAS OBSERVED. THE HEMOSTATIC VALVE DISLODGED INSIDE THE HUB. THE HEMOSTATIC VALVE ITSELF WAS NOT BROKEN/CRACKED. FLUOROSCOPY CONFIRMED THE PRESENCE OF AIR IN THE RIGHT ATRIUM WHICH WAS SUBSEQUENTLY ASPIRATED USING A PIGTAIL CATHETER. CORONARY ANGIOGRAPHY WAS ALSO PERFORMED. AT THE TIME OF LEAVING THE PROCEDURE ROOM, THE HEMODYNAMIC STATUS WAS UNCHANGED FROM BASELINE, AND NO CEREBRAL INFARCTION OR OTHER COMPLICATIONS WERE OBSERVED THE FOLLOWING DAY. PATIENT WAS ASYMPTOMATIC. MAGNETIC RESONANCE IMAGING WAS PERFORMED BUT NO CEREBROVASCULAR ACCIDENT OCCURRED. THERE WAS NO EVIDENCE OF CHAR NOR BLOOD THROMBUS/CLOT. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THAT THE TIP OF THE VIZIGO WAS IN CONTACT WITH THE MYOCARDIUM, AND IT IS POSSIBLE THAT NEGATIVE PRESSURE WAS GENERATED DURING AIR PURGING, RESULTING IN AIR BEING ASPIRATED. DAMAGE TO THE HEMOSTATIC VALVE A

  Patient problems: Air Embolism

  MAUDE report 25860936 ↗
• MalfunctionJul 15, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25834195 ↗
• MalfunctionJul 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25834130 ↗
• MalfunctionJul 14, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VIZIGO AIR WAS BEING DRAWN INTO THE VIZIGO. DURING PLACEMENT OF THE VIZIGO INTO THE PATIENT¿S BODY, AIR WAS BEING DRAWN INTO THE VIZIGO. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25817697 ↗
• MalfunctionJul 13, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25808234 ↗
• MalfunctionJul 8, 2026Backflow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND AIR WAS BEING DRAWN IN FROM THE HEMOSTATIC VALVE. WHEN THE SOUND STAR ECO CATHETER WAS INSERTED AFTER PUNCTURE, AIR WAS BEING DRAWN IN FROM THE HEMOSTATIC VALVE OF THE VIZIGO SHORT. NO AIR WAS INTRODUCED INTO THE PATIENT. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE ISSUE WAS HANDLED BY REPLACING THE SHEATH. AFTER THAT, THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750525 ↗

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