iCast Covered Stent recall
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Why was iCast Covered Stent recalled?
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042
- Product
- iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 11 devices
- Distribution
- US Nationwide distribution in the states of FL, MA, MI, OH, WA.
- Recall date
- October 16, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)