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Class I Medical Device Recall: Terumo Coronary Ostia Cannula 10, 12, 14 Fr

Tue, 06/14/2011 - 8:32am
U.S. Food & Drug Administration

Recall Class: Class I

Date Recall Initiated: May 16, 2011

Product(s): Coronary Ostia Cannula 10 (25 cm) long, model numbers 804115, 804117, 804159, all lot/serial numbers.

6,220 devices are subject to this recall.

Terumo Cardiovascular Systems Corporation (Terumo CVS) decided to remove the product line from the market and discontinue further supply. The company notified customers by letter on May 16, 2011 describing the problem, the potential hazard, and the action to be taken. Customers were instructed to discontinue use and return all products to Terumo CVS.

Reason for Recall: Foreign fragments of adhesive and plastic in the cannula tip may embolize causing arterial injury, hemorrhaging or other serious events requiring unplanned surgery.

Use: The Terumo Coronary Ostia Cannula is indicated for use in delivering cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass.

Recalling Firm:

Terumo Cardiovascular Systems Corporation

6200 Jackson Road

Ann Arbor, MI 48103

Public Contact:

Terumo CVS Customer Service: 1-800-521-2818. 8am to 6pm Mon-Fri.

FDA District: Detroit

FDA Comments:

Terumo is advising customers to immediately discontinue use of any affected product and return all products in inventory.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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