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:


    SOURCE Terumo Cardiovascular Systems
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2

    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:7/11/2014)... July 11, 2014  Rock Creek Pharmaceuticals, Inc. (NASDAQ: ... announced that the Food and Drug Administration ("FDA"), has ... on RCP,s Investigational New Drug ("IND") application before granting ... the US. Dr. Chris Chapman , ... comments on our IND. When we receive the agency,s ...
    (Date:7/11/2014)... HOUSTON , July 11, 2014  Kindred ... proud to announce the opening of its new ... provides outpatient services to people with chronic, hard ... wounds which can lead to amputation, lower leg ... which have delayed closure, and traumatic injury wounds ...
    (Date:7/11/2014)... DUBLIN , July 11, 2014 ... the addition of the "Immunoprotein Diagnostic Testing ... at the highest CAGR of 6% and is ... report to their offering. ... for immunoprotein diagnostic testing has been segmented according ...
    Breaking Medicine Technology:Rock Creek Pharmaceuticals Issues Update On US Investigational New Drug Application 2Kindred Hospital Houston Northwest, With Wound Care Specialists, Opens Outpatient Wound Healing And Hyperbaric Center 2Immunoprotein Diagnostic Testing Market - Forecasts to 2019: Expected to grow at the highest CAGR of 6% and is expected to be valued at USD 4,943.0 million 2
    ... GREEN BAY, Wis., Sept. 16 Top researchers at ... Center in Dallas are exploring the clinical applications of ... potency, and bioavailability. Previous studies have ... than other forms of curcumin, and had a retention ...
    ... Transcatheter Technologies Successfully Performs in Vivo Implantation of the Trinity Transapical Aortic... -- REGENSBURG, Germany, September ... ... if (typeof(lpUnit)==,undefined,) var lpUnit=,PRN,; --> ... var shortURL = ""; BitlyCB.alertResponse = function(data) { var s = ,; var first_result; ...
    Cached Medicine Technology:BCM-95 Demonstrates Superior Anti-Inflammatory Effects 2Transcatheter Technologies Successfully Performs in Vivo Implantation of the Trinity Transapical Aortic Valve System 2Transcatheter Technologies Successfully Performs in Vivo Implantation of the Trinity Transapical Aortic Valve System 3Transcatheter Technologies Successfully Performs in Vivo Implantation of the Trinity Transapical Aortic Valve System 4Transcatheter Technologies Successfully Performs in Vivo Implantation of the Trinity Transapical Aortic Valve System 5Transcatheter Technologies Successfully Performs in Vivo Implantation of the Trinity Transapical Aortic Valve System 6Transcatheter Technologies Successfully Performs in Vivo Implantation of the Trinity Transapical Aortic Valve System 7Transcatheter Technologies Successfully Performs in Vivo Implantation of the Trinity Transapical Aortic Valve System 8
    (Date:7/13/2014)... July 13, 2014 MarketsandMarkets recently ... [3D Modeling; 3D Scanning; 3D rendering; Layout and ... Analysis (2013 - 2018)”, which analyzes and studies ... North America, Western Europe, Eastern Europe, Middle East ... also draws the competitive landscape of the 3D ...
    (Date:7/13/2014)... Athletes with a certain genetic make-up ... according to research presented today at the American Orthopaedic ... The research marks the first of its kind investigating ... physical events that occur after a head injury. ... in the (GT)n genotype were four times more likely ...
    (Date:7/13/2014)... 2014 Recently, MyDressCity.com, one of the ... occasion outfits, has released its new range of ... products are available at discounted prices. Worldwide clients can ... , In the company’s online shop, there are plenty ... are made with great materials. MyDressCity.com’s hot items are ...
    (Date:7/13/2014)... COPENHAGEN, July 13, 2014 A decreased ability ... cognitive impairment and Alzheimer,s disease, while examinations of ... a protein associated with Alzheimer,s, in the brain, ... reported today at the Alzheimer,s Association International Conference ... of the studies, the decreased ability to identify ...
    (Date:7/13/2014)... (PRWEB) July 13, 2014 Celebrity fitness ... has formed a promotional partnership with Aqua Health Labs ... Omega-3 EPA supplement . The collaboration was recently ... celebrity fitness trainer , actor, model, and a ... trainer for A-List celebrities, he has prepared stars including ...
    Breaking Medicine News(10 mins):Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 2Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 3Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 4Health News:Genetic Factors May Be Responsible for Slowing Concussion Recovery in Athletes 2Health News:Cheap Elegant Quinceanera Dresses Unveiled by MyDressCity.com 2Health News:Smell and eye tests show potential to detect Alzheimer's early 2Health News:Smell and eye tests show potential to detect Alzheimer's early 3Health News:Smell and eye tests show potential to detect Alzheimer's early 4Health News:Smell and eye tests show potential to detect Alzheimer's early 5Health News:Smell and eye tests show potential to detect Alzheimer's early 6Health News:Smell and eye tests show potential to detect Alzheimer's early 7Health News:Celebrity Fitness Expert Supports Revolutionary New Health Supplement 2
    ... , NAPA, Calif., Aug. 19 Dey ... today issued an advisory regarding two lots of its Albuterol Sulfate ... that was stolen in McKinney, Texas. , , ... brand name "DEY" and contains thirty 3ml single-dose vials. The lot ...
    ... , , , ... released the following statement after President Obama said that it,s ... the health care reform plans. , , ... "Tonight, President Obama deliberately misled the American people by ...
    ... , , , ... one of four companies to have been awarded a contract to ... The contract becomes effective October 1, 2009. , , ... work with the State of Arizona and offer our innovative health ...
    ... Aug. 19 (HealthDay News) -- People with lung cancer who ... a drug called Tarceva, which is believed to work well ... who take the drug, new research has found. , According ... 20 issue of the New England Journal of Medicine ...
    ... NEW YORK, Aug. 19 One of the few bright spots of ... and HBA Global Expo ( www.hb a e ... activists to deliver a Keynote Presentations on Tuesday, September 15, 2009 at ... New York. Horst M. Rechelbacher, founder of Intelligent Nutrients and ...
    ... a novel robot-assisted endoscopic technique, a team of surgeons ... has successfully treated 200 consecutive patients with thyroid cancer. ... cosmetic benefits that the traditional open operation does not ... Journal of the American College of Surgeons . ...
    Cached Medicine News:Health News:Dey Issues Advisory 2Health News:President Obama Misleads on Abortion Funding in Health Care Reform 2Health News:CIGNA Awarded State of Arizona Health Care Contract 2Health News:Gene Mutation Improves Response to Lung Cancer Drug 2Health News:Gene Mutation Improves Response to Lung Cancer Drug 3Health News:Horst M. Rechelbacher To Deliver HBA Global Expo Keynote Address 2Health News:Horst M. Rechelbacher To Deliver HBA Global Expo Keynote Address 3Health News:New robot-assisted surgical method found successful for treatment of thyroid cancer 2
    ... Professional Diagnostics is a leading provider of ... DFA test menu that includes kits for ... well as miscellaneous conjugates and components. Our ... wide assortment of substrates and kit sizes ...
    ... Medical Professional Diagnostics is a leading provider ... and DFA test menu that includes kits ... as well as miscellaneous conjugates and components. ... a wide assortment of substrates and kit ...
    ... breadth of infectious disease ELISA products make ... standard assay protocols for faster integration into ... products provide increased reliability and run-to-run consistency. ... detection assays for a wide range of ...
    ... disease ELISA products make us a leader ... for faster integration into the busy laboratory, ... reliability and run-to-run consistency. Our Infectious Disease ... a wide range of serological assays including ...
    Medicine Products: