24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Recall Insight

This FDA Devices action (record #Z-0461-2013) was formally reported on December 12, 2012, with the manufacturer initiating the action on November 21, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Terumo Cardiovascular Systems Corporation is listed as the recalling firm, operating out of Ann Arbor, MI. Federal records list the affected scope as 5760 total products.

The documented reason for this recall is: The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential … Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, Unite…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.