Atrium Medical Corporation: Medical Device Recall in 2023 - (Recall #: Z-0291-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 21, 2023

Date Posted: November 22, 2023

Recall Number: Z-0291-2024

Event ID: 93195

Reason for Recall:

Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.

Status: Ongoing

Product Quantity: 141 units

Code Information:

UDI-DI: 00650862853612 Lot Numbers: 464909, 464910

Distribution Pattern:

Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated