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    Device & Drug Safety

    AstraZeneca Issues Warning for BRILINTA's Risk of Increased Bleeding

    AstraZeneca has issued a drug warning letter informing physicians of important safety information for BRILINTA (ticagrelor), a P2Y12 platelet inhibitor recently approved by the FDA.
  • Device & Drug Safety

    August 10, 2011

    AstraZeneca Issues Warning for BRILINTA's Risk of Increased Bleeding

    AstraZeneca has issued a drug warning letter informing physicians of important safety information for BRILINTA (ticagrelor), a P2Y12 platelet inhibitor recently approved by the FDA.
    June 15, 2011

    Boston Scientific, Maquet and Terumo Issue Recalls

    The FDA announced recalls this week for the following cardiovascular care products: 1) Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters; 2) Maquet Datascope Corp. Intra-Aortic Balloon Pumps; and 3)Terumo Coronary Ostia Cannula 10, 12, 14 Fr.
    January 24, 2011

    FDA Warns About Severe Liver Injury Associated with Multaq (Dronedarone)

    FDA is alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq).
    January 13, 2011

    Class I Recall Issued for AngioScore's AngioSculpt PTA Scoring Balloon

    A Class I Recall has been issued for AngioScore's AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform. The device was recalled because of a design defect causing unintended fracture and peeling, and has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. Use of affected devices may lead to retained device fragments or significant arterial injury which may lead to death, or need for additional surgical intervention.
    January 07, 2011

    ev3 Recalls NanoCross™ .014" OTW PTA Dilatation Catheter

    ev3, a Covidien company, has initiated a voluntary recall of specific lots of the NanoCross™ .014" OTW PTA Dilatation Catheter due to the potential for the catheter shaft to crack or break during use. Cracking or breaking of the catheter shaft may result in the inability to inflate or deflate the balloon, and may result in material separation and potential embolization. The device failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, tissue, injury, infarct, bleeding and/or death. 
    September 11, 2010

    FDA Recalls AngioSculpt "EX" PTCA Scoring Balloon Catheter

    The FDA has issued a class I recall for AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty (PTCA) scoring balloon catheters. These catheters may become separated during use, and fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death.
    September 10, 2010

    FDA Issues New Warnings for Gadolinium-based Contrast Agents

    The U.S. Food and Drug Administration is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF), if the drug is administered to certain patients with kidney disease.
    August 18, 2010

    FDA Class 1 Recall for 6 French Engage Introducer Devices

    The FDA has issued a class I recall notice for St. Jude 6 French EngageTM Introducer devices produced between April 27 and June 3, 2010. This recall affects approximately 5,120 devices. Some devices in the affected batches have the potential for separation of the shaft (sheath) from the hub or for a break in the hub assembly. If either of these were to occur during use, a potentially life threatening episode of bleeding could occur.
    March 22, 2010

    FDA Issues Safety Alert on Zocor

    FDA is notifying healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class.
    March 11, 2010

    FDA Issues Recall for Transseptal Sheath Introducer Kit

    FDA and Thomas Medical Products notified healthcare professionals of a Class I recall of the Transseptal Sheath Introducer Kit (also under the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit), which are prescription medical devices used to to pass heart catheters from the right to the left side of the heart.