Home / Recalls / Medical Devices
Atrium Medical Corporation recalls Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of
Recalled November 22, 2023 · FDA recall Z-0291-2024 · Atrium Medical
Hazard
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. · FDA Class II
Units
141 units
Sold at
Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
Description
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
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 indication excludes renal arteries. REF: 85361
Manufacturer(s)
Atrium Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →