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

Recall Insight

This FDA Devices action (record #Z-0291-2024) was formally reported on November 22, 2023, with the manufacturer initiating the action on September 21, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Atrium Medical Corporation is listed as the recalling firm, operating out of Merrimack, NH. Federal records indicate 141 units units are affected.

The documented reason for this recall is: Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Distribution data in the federal record shows the product reached: Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.