# FDA recall Z-0291-2024

> **Atrium Medical Corporation** · Class II · device recall initiated 2023-09-21.

## 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

- **Recall number:** Z-0291-2024
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-21
- **Report date:** 2023-11-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Merrimack, NH, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0291-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0291-2024. Source: US FDA. Licensed CC0.

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