VIZIGORecalls & reported problems across all models

We found 3 models of VIZIGO by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 5,206 adverse event reports in the FDA's MAUDE database, received between Jul 27, 2018 and Sep 30, 2026 — classified as 6 deaths, 210 injuries, 4,990 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2,012 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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. 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

VIZIGO recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 16, 2024Open, Classified

   Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

   Z-1290-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 21, 2023Open, Classified

   Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

   Z-1320-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Feb 21, 2023Open, Classified

   Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

   Z-1319-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jun 29, 2022Open, Classified

   Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could be a source for infection.

   Z-1677-2022 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported VIZIGO problems

VIZIGO models

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

• VIZIGO D138502

  INTRODUCER, CATHETER
  2 recalls4 deaths2,839 reports
• VIZIGO D138501

  INTRODUCER, CATHETER
  2 recalls2 deaths2,005 reports
• VIZIGO D138503

  INTRODUCER, CATHETER
  362 reports

Recent 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, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954730 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953603 ↗
• MalfunctionSep 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951315 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950871 ↗
• MalfunctionSep 30, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949584 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  It was reported that a patient underwent a supraventricular tachycardia (SVT) ablation procedure with a VIZIGO and a leakage issue occurred.It was reported that during the operation, fluid (saline solution) escaped from an unintended location of the tubing; the hub area according to a picture that was received. A second device was used to complete the operation. There was no adverse event reported on patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944784 ↗
• MalfunctionSep 30, 2026Material Separation

  It was reported that a patient underwent an Atrial Fibrillation (AFib) ablation procedure with a VIZIGO and the hemostatic valve was dislodged inside the hub. It was reported that hemostatic valve of Vizigo was damaged. The while gasket was found abnormal. Change another sheath to complete the operation. There was no adverse event reported on patient. Additional information received indicating the hemostatic valve was dislodged inside the hub and not dislodged outside of the hub. The brim cap/hub did not detach from the sheath. No air entered the patient¿s body. There was no blood loss.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941966 ↗
• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940922 ↗
• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935472 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921581 ↗
• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920599 ↗
• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917705 ↗
• MalfunctionSep 28, 2026Difficult to Advance

  It was reported that a patient underwent an Atrial Fibrillation (AFib) ablation procedure with a VIZIGO and while trying to cross the septum after going transseptal, the VIZIGO sheath would not cross. The Regional Technology Specialist (RTS) reported that the physician tried different angles without resolution. The RTS reported that they pulled the sheath from the patient, inspected it, but found no deformities. They replaced the VIZIGO sheath and the issue was resolved. The procedure continued. No adverse patient consequence was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916931 ↗
• MalfunctionSep 25, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905972 ↗
• MalfunctionSep 25, 2026Backflow; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903386 ↗

Other Biosense Webster Inc products

• THERMOCOOL SMARTTOUCH SF8 models · 6,238 reports · 1 recall
• QDOT MICRO7 models · 1,418 reports
• ThermoCool SmartTouch7 models · 1,163 reports
• PENTARAY NAV12 models · 842 reports · 4 recalls
• OCTARAY Mapping Catheter6 models · 407 reports
• CARTO VIZIGO2 models · 349 reports
• SOUNDSTAR6 models · 260 reports
• PREFACE3 models · 193 reports