Atrium Advanta V12 Covered Stent System Recalled for Weld Failure
Atrium Medical Corporation is recalling 141 units of the Advanta V12 Covered Stent System due to a balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Affected units were distributed to eleven countries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a vascular stent with a weld defect that could prevent proper deployment during critical medical procedures. Although no illnesses or injuries have been reported, the hazard poses a significant risk of harm, as failed stent deployment in vascular intervention could lead to serious complications.
Plain-English summary
Atrium Medical Corporation is recalling the Advanta V12 Covered Stent System (10mm x 59mm x 80cm, Lot Numbers 464909 and 464910) due to a potential balloon-to-catheter weld failure. This device is used to restore and improve blood vessel patency in iliac and renal arteries.
The defect may cause loss of balloon pressure during stent deployment, which could result in improper stent placement or failed deployment. A total of 141 units have been recalled and were distributed to Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and the United Kingdom.
No injuries or adverse events related to this defect have been reported to date. Patients who have received this stent or physicians with affected inventory should contact Atrium Medical Corporation or the FDA for guidance on next steps, including product replacement or return procedures.
The recalled product
- Product
- 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 indicat
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Stent
- Hazard
- weld-failure
- deployment-failure
- pressure-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00650862853612 Lot Numbers: 464909
- 464910
Distribution
Distribution scope not specified by the agency.
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