Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vasc
Summary
The FDA issued a Class II for Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product by Atrium Medical Corporation. Reason: The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling..
Details
Source
Device Recall
External ID
Z-2589-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Lot/Code Info: Lot 458755 Serial numbers 458755001 458755007 458755013 458755019 458755025 458755002 458755008 458755014 458755020 458755026 458755003 458755009 458755015 458755021 458755027 458755004 458755010 458755016 458755022 458755028 458755005 458755011 458755017 458755023 458755029 458755006 458755012 458755018 458755024 458755030
Quantity Affected: 28 units
Reason for Recall
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
Distribution
Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-25
Company
Merrimack, NH
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 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Atrium Medical Corporation has 88 FDA actions in our database, including 86 recalls and 2 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 (Atrium Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Atrium Medical Corporation have FDA actions?
Atrium Medical Corporation has 88 FDA actions in our database, including 86 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2589-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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