Atrium Medical Corporation: Device Recall

Recall #Z-0024-2025 · 09/09/2024

Class II: Risk

Recall Details

Recall Number: Z-0024-2025
Classification: Class II
Product Type: Device
Recalling Firm: Atrium Medical Corporation
Status: Ongoing
Date Initiated: 09/09/2024
Location: Merrimack, NH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11 devices

Reason for Recall

There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

Product Description

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Distribution Pattern

US Nationwide distribution in the states of FL, MA, MI, OH, WA.

Other Recalls by Atrium Medical Corporation

Class II: Risk 05/03/2024

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II: Risk 05/03/2024

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II: Risk 05/03/2024

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II: Risk 05/03/2024

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II: Risk 05/03/2024

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

View all recalls by Atrium Medical Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.