FDA recall Z-0291-2024

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

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

Key facts

Status

Ongoing

Initiation date

2023-09-21

Report date

2023-11-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0291-2024