Navigation Links
FDA Classifies Recent Terumo CVS Recall of Coronary Ostia Cannulae as Class I Action
Date:6/16/2011

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:


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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Reclassifies Certain Digital Mammography Devices
2. Aethlon Medical to Discuss Recent Progress at the LHA Life Sciences & Medical Technologies Virtual Conference on June 16
3. Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765
4. A Recent Study by ITGs Majestic Market Research Indicates a Strong Launch for Gilenya in Spite of Its Time-Consuming Initiation Process
5. In a New Audio Interview at SmallCapVoice.com, Gerard Dab, Chairman and CEO of Visual Healthcare Corp., Provides Details Regarding Recent News
6. Applied Medical Sues Covidien, Asserting Recently Issued Universal Seal Trocar Patent
7. Instacare Corp. Board of Directors Considers Recent Merger Proposal Inadequate
8. Arena Pharmaceuticals Announces First Quarter 2011 Financial Results and Recent Developments
9. Simcere Announces Recent Progress of Qiangkes Registration
10. Webcast and Conference Call Alert: Isis Pharmaceuticals Holds Webcast to Discuss Recent Advances in its Development Pipeline
11. McDonald Hopkins Law Firm Alert: Recent Court of Appeals Decision Highlights the Need to Properly Define the Role of Sales Representatives
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... global  pacemaker market  is expected to reach USD 12.3 billion by 2025, according ... cardiac conditions coupled with the availability of medical coverage is a key driving ... devices are supporting the expansion of this vertical. ... ... Logo ...
(Date:1/19/2017)... The Global Therapy Partnering Terms and Agreements ... deals and agreements entered into by the world,s leading ... Top deals by value - Deals listed by company ... The report provides understanding and access to the partnering ... healthcare companies. The report provides an analysis of ...
(Date:1/19/2017)... , Jan. 18, 2017 The drug ... billion by 2021 from USD 1,179.20 billion in 2016, ... Increasing prevalence of chronic diseases, increasing demand for ... factors driving the growth of this market. Whereas, self-administration ... generic drugs offer significant growth opportunities for players operating ...
Breaking Medicine Technology:
(Date:1/19/2017)... , ... January 19, 2017 , ... ... tech innovators, engineers, and scientists from around the world, announces the launch of ... a quick and easy portal to research breakthroughs and trending news, vital information ...
(Date:1/19/2017)... ... January 19, 2017 , ... ... has recently unveiled impressive transportable capabilities with their iMedHD2™ Portable Teleultrasound ... extension to RMT technology that delivers HD, dynamic, streaming ultrasound images and video ...
(Date:1/19/2017)... ... January 19, 2017 , ... WholeHealth is announcing ... Drs. Alexander Paziotopoulos, Andrew Petersen and Trish Henrie-Barrus will be present Saturday and ... leading recovery program. , “We know it’s easy to get carried away ...
(Date:1/19/2017)... ... January 19, 2017 , ... Dr. ... Board of Dermatology and fellowship trained Mohs and cosmetic surgeon. After extensive dermatology ... Dr. Li completed his internship in internal medicine at the Emory University and ...
(Date:1/19/2017)... ... January 19, 2017 , ... Bio-Optronics Inc. is proud ... CTMS workflow designed to seamlessly integrate and streamline the way researchers prepare and ... page, maximizing usability and improving efficiency significantly for users – a first in ...
Breaking Medicine News(10 mins):