Guidant, LLC, maker of a cardiac defibrillator, pled guilty to criminal violations of the Food and Dug Administration Cosmetic Act which requires that medical device companies disclose risks of serious injury and death that are associated with their products. The Guidant defibrillator was used in cardiac surgery to produce a shock to restart the heart…
Continue reading ›Cardiac patients should be aware of the Class I Recall involving Thomas Medical Products with the company’s Transseptal Sheath Introducer Kit, also known as HeartSpan, CHANNEL FX, and Torflex, Braided Guiding Introducer Kit. This medical device is used in cardiac patients to pass a heart catheter from one side of the heart to the other…
Continue reading ›Dialysis Systems by Baxter called HomeChoice and HomeChoice PRO are under a medical device recall following reports from physicians that people have experienced serious injury and one known death because of a defect in the product. The specific defect is unknown at this time. What is known is that the Automated PD system which is…
Continue reading ›Millions of Becton, Dickinson and Company catheter systems are involved in a recall because of a defect in the product that may result in injury or death to a user. The direct flaw of the catheter system involves the risk of an air embolism and leakage of blood or therapeutic fluids. These risks pose an…
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