The U.S. Food & Drug Administration (FDA) has announced a Class I Recall for the Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface due to potentially elevated levels of harmful bacteria that can cause fevers, infections, acute...
The U.S. Food & Drug Administration (FDA) has announced a recall for certain Kodama Intravascular Ultrasound Catheters which may shatter after being implanted, increasing the risk of adverse health complications including blood vessel blockage, heart attack, heart arrhythmia and stroke.
The U.S. Food & Drug Administration (FDA) is warning that Stryker's Scandinavian Total Ankle Replacement (STAR Ankle) device has been linked to more than 1,800 adverse event reports since 2009, including nearly 300 cases of fractured plastic components.
The U.S. Food & Drug Administration (FDA) has announced a recall for certain Boston Scientific EMBLEM S-ICD Subcutaneous Electrodes due to an increased risk of fracture after implantation, which could result in serious adverse events including injury or death.
Paragard, an intrauterine birth control device (IUD) manufactured by CooperSurgical, Inc., has recently been linked to serious side effects including breaking during removal, perforation of the uterine wall, migration of the IUD, hysterectomy, and death.