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Angelcare is voluntarily recalling its Movement and Sound Monitors with Sensor Pads due to the risk of a pliable cord wrapping around a baby’s neck in the crib. Read More
Medtronic is conducting a voluntary Class I recall of multiple guidewires used to place diagnostics and interventional devices in the coronary and peripheral blood system. Read More
The International Medical Device Regulators Forum adopted four final guidance documents and two new work items relating to the Medical Device Single Audit Program during a meeting in Brussels last month. Read More
Edwards Lifesciences’ Sapien transcatheter aortic valve performs as well in routine clinical practice as it did in clinical trials, an analysis of registry data shows. Read More
DePuy Orthopaedics has agreed to pay about $2.5 billion to patients who needed surgery to replace one of the company’s Articular Surface Replacement metal-on-metal hip implants. Read More
The Sorin Group has sent a Dear Doctor letter to physicians after Hong Kong’s Department of Health received eight reports of faulty elective replacement indicators used to program the settings on three of the company’s pacemakers. Read More
Johnson & Johnson is expected to pay more than $4 billion to settle lawsuits against the company over injuries attributed to Articular Surface Replacement (ASR) metal-on-metal hips made by its DePuy business unit, multiple news sources report. Read More
Physicians responding to a recent FDA survey reported good results with Intuitive Surgical’s da Vinci surgical system, but also highlighted a range of failures involving the robotic device. Read More