Reported Sep 14, 2022 · Ongoing
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into…
Biosense Webster, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biosense Webster, Inc. · 15715 Arrow Hwy · Irwindale, CA · 91706-2006
Is this the product you have?
- CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
- REFD138501. Used to introduce various cardiovascular catheters into the heart
- Lot codes and dates
- UDI-DI10846835016253
- Lot Number00002001
- Amount recalled
- 98
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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