🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: September 21, 2023 Atrium Medical Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00650862853612 Lot Numbers: 464909, 464910
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Atrium Medical Corporation
Reason for Recall:
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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 Codes/Lot Numbers:

UDI-DI: 00650862853612 Lot Numbers: 464909, 464910

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0291-2024

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