FDA recall Z-1286-2021

Product

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

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

Distribution

Worldwide distribution.

Key facts

Status

Completed

Initiation date

2021-02-26

Report date

2021-03-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irwindale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1286-2021