CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into
Summary
The FDA issued a Class II for CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduc by Biosense Webster, Inc.. Reason: Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the .
Details
Source
Device Recall
External ID
Z-1677-2022
Action Date
2022-09-14
Status
Ongoing
Category
device
Product Description
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Lot/Code Info: UDI-DI: 10846835016253, Lot Number: 00002001
Quantity Affected: 98
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME, FL, IA, NM, NH, TN, WI, OH, SC, CA, IN.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-29
Company
Irwindale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Biosense Webster, Inc. has 18 FDA actions in our database, including 5 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biosense Webster, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biosense Webster, Inc. have FDA actions?
Biosense Webster, Inc. has 18 FDA actions in our database, including 5 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1677-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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