CARTO VIZIGO Bi-Directional Guiding Sheath — Class II medical device recall Z-1290-2024
Ongoing recall by Biosense Webster, Inc., reported 2024-03-20, distributed nationwide. Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main man
| Recall number | Z-1290-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irvine, CA, United States |
| Recall initiated | 2024-02-16 |
| Classified | 2024-03-13 |
| Reported by FDA | 2024-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 853 units |
| UPC / GTIN / UDI-DI | 10846835016277 |
| Lot numbers | 60000282 |
| Model numbers | D128502 |
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 for recall
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1290-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.