FDA Device recall Z-1290-2024
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibili…
- FDA Device
- Class II
- ongoing
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibili… by Biosense Webster, citing due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1290-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-16 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biosense Webster |
| Distribution | US |
Product
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180¿ and counterclockwise = 180¿. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems.
Reason
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Identifiers
| code_info | Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1290-2024%22
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