Biosense Webster, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1677-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.

Product Classification:

Class II

Date Initiated: June 29, 2022

Date Posted: September 14, 2022

Recall Number: Z-1677-2022

Event ID: 90647

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 98

Code Information:

UDI-DI: 10846835016253, Lot Number: 00002001

Distribution Pattern:

US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN.

Voluntary or Mandated:

Voluntary: Firm initiated