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    Device & Drug Safety

    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.

  • Device & Drug Safety

    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.
    February 11, 2010

    Class I Recall for SafeSheath Device

    Citing the possibility of the sheath tip breaking off and separating while the sheath is inside a blood vessel, the FDA and Thomas Medical Products Inc. have announced a Class I Recall of certain lots of the product, tube-like devices placed into blood vessels to insert pacing or defibrillator wires and catheters into blood vessels.
    January 21, 2010

    FDA Completes Safety Review of Meridia

    FDA has completed its safety review of additional data that indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine.
    January 05, 2010

    FDA Issues Class I Recall for ev3 Endovascular Trailblazer Support Catheter

    ev3 Endovascular, Inc. and FDA are notifying healthcare professionals of a Class I Recall of the Trailblazer Support Catheter.
    December 11, 2009

    FDA: Nopramin Should NOT Be Given to Patients With Family History of Electrical Disturbances in the Heart

    Sanofi-Aventis and FDA are notifying healthcare professionals of changes to the Warnings and Overdosage sections of the Prescribing Information for Norpramin (desipramine hydrochloride), indicated for the treatment of depression. The new safety information states that extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances; and that seizures precede cardiac dysrhythmias and death in some patients.
    November 19, 2009

    FDA Alert on Potential Interactions Between Clopidogrel and PPI

    Public alert on potential interactions between clopidogrel (marketed as Plavix) and the proton pump inhibitor omeprazole (marketed as Prilosec) issued by the Food and Drug Administration (FDA) on Tuesday, Nov. 17, 2009.
    November 19, 2009

    BARI 2D Sub-Study Finds Revascularization Superior in Quality-of-Life Benefits

    Results from sub-studies of the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetics (BARI 2D) trial, including an assessment of quality-of-life and economic outcomes in type 2 diabetics with coronary artery disease (CAD) undergoing revascularization versus medical therapy alone.
    November 04, 2009

    Cordis Initiates Nationwide Recall of CROSSOVER Sheath Introducer

    Cordis and FDA are notifying healthcare professionals of a nationwide recall of all lots of the CROSSOVER Sheath Introducer, a long-coil reinforced,kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
    September 11, 2009

    FDA Issues Class I Recall for Neuron 5F Select Catheter

    Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels.
    July 31, 2009

    Abbott Issues Voluntary Recall of POWERSAIL® Coronary Dilatation Catheters

    Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage.