Biosense Webster, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1285-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 26, 2021

Date Posted: March 31, 2021

Recall Number: Z-1285-2021

Event ID: 87440

Reason for Recall:

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

Status: Completed

Product Quantity: 71,473 units

Code Information:

All Lots

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated