Recalls / —

—#209992

Product

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

FDA product code

PRL — Iliac Covered Stent, Arterial

Device class

Class 3

Medical specialty

Unknown

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 trium.icastcooklabel.act@getinge.com. 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.

Recalling firm

Firm

Atrium Medical Corporation

Address

40 Continental Blvd, Merrimack, New Hampshire 03054-4332

Distribution

Distribution pattern

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

Timeline

Recall initiated

2024-09-09

Posted by FDA

2024-10-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #209992. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.