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Terminated

CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.

FDA Recall Z-1841-2012 · Posted 2012-06-20

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDWF
Date Initiated2012-05-09
Date Terminated2013-07-11
Product Quantity133,793 (each)

Reason for Recall

During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti

Firm Action

Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter advises customers to discontinue use of the affected product and to return the product to the firm. A Response Form was attached for customers to complete and return. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution-USA (nationwide) including the states of AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates (UAE), and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K770429CANNULAE, AORTIC, ARCH, HIGH FLOW3M Health Care, Sarns · 1977-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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