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
Reported: November 22, 2023 Initiated: September 21, 2023 #Z-0291-2024
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
Reason for Recall
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 141 units
- Distribution
- Foreign: Australia, Belgium, Canada, France, Germany, Greece, Malta, Netherlands, New Zealand, Portugal, and United Kingdom
- Location
- Merrimack, NH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Atrium Medical Corporation. Units affected: 141 units.
Why was this product recalled? ▼
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2023. Severity: Moderate. Recall number: Z-0291-2024.
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