Biosense Webster, Inc. recalls Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE

Recalled March 31, 2021 · FDA recall Z-1287-2021 · Biosense Webster

Hazard

There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism · FDA Class II

Units

N/A

Sold at

Worldwide distribution.

Description

There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism

Product

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 accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.

Manufacturer(s)

Biosense Webster, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →