Biosense Webster, Inc. 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 coun Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 coun
Brand
Biosense Webster, Inc.
Lot Codes / Batch Numbers
Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282
Products Sold
Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282
Biosense Webster, Inc. is recalling CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding due to Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
Recommended Action
Per FDA guidance
On 02/16/2024, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via FedEx to customers informing them that Biosense Webster identified through a complaint investigation that a mix-up occurred during the manufacturing of two lots. The devices could potentially be shorter in length (24 1/8 inches (61.28 cm) instead of, 28 inches (71 cm). Customer are instructed/informed: If a CARTO VIZIGO" Bi-Directional Guiding Sheath, Medium Curve (Catalog Number: D-1385-02) from Lot Numbers 60000282 and 60000287 is being used in their facility, they should continue to follow the IFU. The Instructions for Use, on Page 7, instructs users to inspect all components before use, and prior to inserting the device into the patient, pre-assemble the sheath, dilator, and stylet on the table. While setting up for a procedure, if the dilator is protruding out the tip of the sheath more than 4 inches (10 cm), do not use the sheath. Destroy the device following their standard process. Please complete the Attestation of destruction form (Attachment 2) to receive a replacement and email it to: Email: OneMD-Field-Actions@its.jnj.com Subject: Attention: BWI Field Action Coordinator- Attestation product destruction. For questions or further assistance, contact Biosense Webster at OneMD-Field-Actions@its.jnj.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026