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Carto Vizigo D138504

by Biosense Webster Inc United States GUDID

Product code DYB

Regulatory status

as of 24 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10846835026252 UDI-DIDate11 May 2026ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

7 recalls · 4 ongoing · FDA

    • Ongoing Z-1290-2024 FDA Class II initiated 16 Feb 2024

    Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

  • 2 recalls, same reason

    • Ongoing Z-1319-2023 FDA Class II initiated 21 Feb 2023
    • Ongoing Z-1320-2023 FDA Class II initiated 21 Feb 2023

    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

    • Ongoing Z-1677-2022 FDA Class II initiated 29 Jun 2022

    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.

  • 3 recalls, same reason

    • Completed Z-1286-2021 FDA Class II initiated 26 Feb 2021
    • Completed Z-1285-2021 FDA Class II initiated 26 Feb 2021
    • Completed Z-1287-2021 FDA Class II initiated 26 Feb 2021

    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

Specification

GUDID · synced 23 Oct 2026

Trade Name
Carto Vizigo
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
D138504
Primary DI / UDI-DI
10846835026252
510(k) Number
FDA Product Code
DYB
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1340
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K170997)

Other devices from Biosense Webster Inc

See all devices from Biosense Webster Inc →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (9)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 621acc2f-8a86-4000-b2e8-7b4144195be1 37 fields · synced 23 Oct 2026