Z-0024-2025Class II

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Name: Z-0024-2025 iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Creator: Atrium Medical Corporation
Published: 2024-09-09
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2024-09-09 / Open, Classified / root cause: labeling and UDI

FDA source

Atrium Medical Corporation began a recall of iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 on 2024-09-09. FDA classified it as Class II and gives the reason as "There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0024-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-09
Posted: 2024-10-07
Recalling firm: Atrium Medical Corporation
Product: iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Product code: PRL Iliac Covered Stent, Arterial
Reason for recall: There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Removal notification letter dated 9/9/24 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received one or more of the iCast Covered Stents from the affected Product REF and Serial Numbers. Please examine your inventory immediately to determine if you have any of the iCast Covered Stents with the Product REF and Serial Numbers listed in this notice, which can be found on the product label. " Should you have any affected product, do not use the product and remove it from areas of use. " Please forward this information to all current and potential iCast Covered Stent System users within your hospital/ facility. " If you are a distributor who has shipped any affected product(s) to customers, please forward this document to their attention for appropriate action. " Please contact your local Atrium Medical Corporation/Getinge Customer Support department at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to receive instructions for returning any affected unused product within expiry per the iCast label. You will receive credit upon the return of any affected devices. " Whether or not you have affected product(s) with the Product REF number and Serial Numbers listed in this notice, please complete and sign the attached MEDICAL DEVICE - REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by emailing a scanned copy to [email protected]. Type of Action by Atrium Medical Corporation/Getinge: If requested, Atrium Medical Corporation/Getinge will facilitate the removal of affected products from your facility and provide credit for your return of these products. If you have any questions, please call Atrium Medical Corporation/Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m.
Quantity in commerce: 11 devices
Distribution: US Nationwide distribution in the states of FL, MA, MI, OH, WA.
Product codes and lots: UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0024-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0024-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-07

Product code PRL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)