Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of
Summary
The FDA issued a Class II for Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for by Atrium Medical Corporation. Reason: Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment..
Details
Source
Device Recall
External ID
Z-0291-2024
Action Date
2023-11-22
Status
Ongoing
Category
device
Product Description
Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361
Lot/Code Info: UDI-DI: 00650862853612 Lot Numbers: 464909, 464910
Quantity Affected: 141 units
Reason for Recall
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Distribution
Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-21
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 200 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-0291-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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