Items added to the Center for Devices and Radiological Health's Consumer website within the last month. http://www.fda.gov/cdrh/consumer/ en-us Wed, 10 Feb 2010 03:54:35 GMT webo@cdrh.fda.gov http://www.fda.gov/cdrh/images/homepg/c-d-r-h.gif http://www.fda.gov/cdrh/consumer/ Reason for Recall: The sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries. Thu, 04 Feb 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm199918.htm The Medtronic Melody® Transcatheter Pulmonary Valve is a manufactured replacement pulmonary heart valve that had already been previously repaired. The pulmonary valve is one of four valves in the human heart that help pump blood throughout the body. Fri, 29 Jan 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm199258.htm The device separates the red blood cells from plasma to determine the patient?s hematocrit. A low hematocrit reading is a possible indicator of anemia. Thu, 28 Jan 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm199186.htm The ProGEL? Pleural Air Leak Sealant is a surgical sealant made of human serum albumin and a polyethylene glycol (PEG) crosslinker that forms a clear flexible gel on mixing. Surgeons use the device to seal air leaks on lung tissue after standard closure.. Wed, 27 Jan 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm199028.htm Reason for Recall: Inspections conducted in October 2009 of the company's facilities found that their needles "cored" in 60 to 72 percent of tests. These cores can cause the ports to leak and they can also potentially enter a patient's body when... Tue, 26 Jan 2010 05:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm198790.htm