Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2013 - (Recall #: Z-0670-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery

Product Classification:

Class II

Date Initiated: January 7, 2013

Date Posted: January 23, 2013

Recall Number: Z-0670-2013

Event ID: 64007

Reason for Recall:

Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.

Status: Terminated

Product Quantity: 6830 total all products

Code Information:

Lot number: 0680122, 0680751and Catalog number: 12325

Distribution Pattern:

Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).

Voluntary or Mandated:

Voluntary: Firm initiated