VIZIGO D138501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,005 adverse event reports that list this exact device (DI 10846835016253), received between Jul 27, 2018 and Sep 30, 2026 — classified as 2 deaths, 90 injuries, 1,913 malfunctions.

The most frequently reported specific device problem is “Material Separation” (794 reports).

2 FDA recall records name this device's identifier, 2 still open.

5 other recalls cover devices cleared under the same FDA submission (K170997); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

2. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,005 reports, 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, 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 50935472 ↗
• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920599 ↗
• 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; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903386 ↗
• MalfunctionSep 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902466 ↗
• MalfunctionSep 24, 2026Backflow; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889835 ↗
• MalfunctionSep 17, 2026Break

  It was reported that a patient underwent a pulmonary vein isolation ablation procedure with a Vizigo sheath and the physician noticed the tip was frayed. The doctor noticed the VIZIGO¿ sheath was not advancing to the location he wanted it to with ease. He exited the body and noticed the sheath was frayed at the tip. The sheath was replaced and the issue was resolved. The procedure continued and was completed. No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806192 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697424 ↗
• MalfunctionSep 4, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600190 ↗
• MalfunctionSep 3, 2026Material Protrusion/Extrusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50597231 ↗
• MalfunctionSep 3, 2026Fluid/Blood Leak; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596888 ↗
• MalfunctionAug 28, 2026Mechanical Problem; Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492452 ↗
• MalfunctionAug 26, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458839 ↗
• MalfunctionAug 20, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50356380 ↗
• MalfunctionAug 18, 2026Material Too Soft/Flexible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311992 ↗
• MalfunctionAug 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50290947 ↗
• MalfunctionAug 7, 2026Device-Device Incompatibility

  It was reported that a patient underwent a cardiac ablation procedure with a VIZIGO and catheter for which Biosense Webster¿s Product Analysis Lab (PAL) identified the hemostatic valve dislodged inside the hub of the device. It was initially reported by the customer that the dilatator could not go through the valve of the VIZIGO Sheath. Issue happened before the operation. The sheath was not used on the patient, therefore, no patient hazard/consequence and the procedure could be finished normally.There was no damage to the sheath or dilator noticed and no occlusion was noticed when irrigating the sheath. No observable blockage. The customer's reported impeded sheath issue is not considered to be MDR Reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote. On 13-Jul-2026, the BWI PAL revealed that a visual inspection of the returned device found the hemostatic valve dislodged inside the hub of the device. This findings was reviewed and assessed as an MDR Reportable Malfunction since the integrity of the device has been compromised.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50182985 ↗
• MalfunctionAug 7, 2026Fluid/Blood Leak

  It was reported that a patient underwent an Atrial Fibrillation (AFib) ablation procedure with a VIZIGO and a fluid leakage issue occurred. It was reported that during the operation, fluid (saline solution) escaped from an unintended location of the sheath. A second device was used to complete the operation. There was no adverse event reported on patient.The issue was suspected to be in the hemostatic valve area. The brim cap did not detach and the hub did not detach from the sheath. No air entered the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181006 ↗
• MalfunctionAug 5, 2026Expiration Date Error

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150205 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170997. One submission often covers many models, so check the product and lot details in each record.

• Z-1290-2024 · Feb 16, 2024 · Open, Classified
  CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac a
• Z-1320-2023 · Feb 21, 2023 · Open, Classified
  Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
• Z-1287-2021 · Feb 26, 2021 · Completed
  Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide access
• Z-1286-2021 · Feb 26, 2021 · Completed
  Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessi
• Z-1285-2021 · Feb 26, 2021 · Completed
  Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessi