Atrium Medical Corporation: Medical Device Recall in 2024 - (Recall #: Z-0024-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Product Classification:

Class II

Date Initiated: September 9, 2024

Date Posted: October 16, 2024

Recall Number: Z-0024-2025

Event ID: 95329

Reason for Recall:

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

Status: Ongoing

Product Quantity: 11 devices

Code Information:

UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated