Question 1

Is 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 c recalled?

Accepted Answer

Biosense Webster, Inc. is recalling 853 units of the CARTO VIZIGO Bi-Directional Guiding Sheath (Model REF D128502) because devices intended for testing and validation were accidentally mixed into the regular commercial supply. These steerable sheaths are used during heart procedures to help doctors navigate catheters into the cardiac anatomy. Because these specific units did not undergo the standard final manufacturing process, they may not meet safety and performance specifications. Consumers should contact their healthcare provider or the manufacturer to determine if a device used in their care was part of this affected batch.

Question 2

What should I do?

Accepted Answer

Identify if you have the affected CARTO VIZIGO Bi-Directional Guiding Sheath by checking the packaging for Product Number D-1385-02 and UDI-DI code 10846835016277. Check your device for Lot Number 60000282, which is the specific lot identified in this recall. If you are a healthcare provider, immediately stop using devices from the affected lot and quarantine them to prevent clinical use. Contact Biosense Webster, Inc. at their Irvine, California headquarters or your local representative for specific instructions on returning the affected products and obtaining replacements. If you are a patient who has recently undergone a cardiac procedure involving a guiding sheath, contact your healthcare provider or Biosense Webster for further instructions and information regarding your specific case. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Question 3

How do I get a refund or replacement?

Accepted Answer

Contact your healthcare provider or the manufacturer for further instructions and potential refund

Biosense Webster, Inc.: CARTO VIZIGO Guiding Sheaths Recalled Due to Manufacturing Error

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

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