FDA Classifies Recent Terumo CVS Recall of Coronary Ostia Cannulae as Class I Action
ANN ARBOR, Mich., June 16, 2011 /PRNewswire/ -- Terumo Cardiovascular Systems (Terumo CVS) announced today that the U.S. Food and Drug Administration has classified as a Class I action the company's recent voluntary recall of its Coronary Ostia Cannula. Terumo CVS discovered several instances of adhesive build-up and/or skiving of plastic (plastic flash) inside the distal tip of the cannula. The defect was discovered during in-house inspection after Terumo CVS implemented a new inspection process for the cannula; Terumo CVS has not received any reports of the defect in clinical use.
Coronary ostia cannulae are used to deliver cardioplegia solution to the coronary arteries during cardiac surgery.
Excess plastic or adhesive in the cannula tip could potentially narrow the interior diameter of the tip, resulting in inadequate delivery of cardioplegia and/or a prolonged surgical procedure if the narrowing results in lowered cardioplegia flow rates. If the excess plastic or adhesive were to detach from the tip of the cannula, it could create an embolism in the coronary vasculature.
Terumo CVS has not received any reports of patient injuries associated with this defect.
Terumo CVS decided to remove the product line from the market and discontinue further supply. The company notified all 42 affected customers of the recall action in a written notice on May 16, 2011, advising customers to return all product for full credit. The company also identified possible alternative products from another manufacturer.
FDA has been informed of this action.
If customers have questions or would like additional information, they should contact Terumo CVS Customer Service, 1-800-521-2818.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
About Terumo Cardiovascular Systems
Terumo Cardiovascular Systems Corporation manufactures and markets medical devices for the global cardiac surgery market. The company is headquartered in Ann Arbor, Michigan with manufacturing operations in Ann Arbor; Elkton, Maryland; and Ashland, Massachusetts. It is one of several subsidiaries of Terumo Corporation of Japan that is focused exclusively on cardiac and vascular specialties. Terumo CVS entered into consent decree with FDA regarding improvements to the Quality System at its Ann Arbor manufacturing facility. For more information, visit www.terumo-cvs.com.
About Terumo Corporation
Terumo Corporation is a premier global medical device company with annual sales of more than 3.4 billion dollars for the fiscal year ending March 31, 2010. Founded in 1921, the company develops, manufactures and distributes world-class medical devices, such as syringes, blood bags and IV solutions. Terumo has the biggest share of the world markets for angiography guide wires and perfusion products and is a leading developer of interventional products, such as catheters and stents. For more information, visit www.terumo.com.
SOURCE Terumo Cardiovascular Systems