FDA Medical devices recall ·
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 recall
- Recall number
- Z-0024-2025
- Date
- (initiated September 9, 2024)
- Company / brand
- Atrium Medical Corporation
40 Continental Blvd, Merrimack, NH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Why was it recalled?
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042
Distribution
US Nationwide distribution in the states of FL, MA, MI, OH, WA.
States: Florida Massachusetts Michigan Ohio Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0024-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.