CDRH New Update

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.govon April 26, 2019. To view listings for other dates, see CDRH New - News and Updates.

Consumer Information on: XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate - P180014 Mammography Problems at East Palestine Family Medical Clinic in East Palestine, Ohio: FDA Safety Communication Class I Recall: Edwards Lifesciences Recalls Miller and Fogarty Atrioseptostomy Dilation Catheters Due to Balloon Deflation, Fragmentation and Detachment Issue FDA in Brief: FDA reminds health care professionals about risks of Wingspan Stent System after study shows increased risk of stroke or death when used outside of the FDA-approved indications Press Release: FDA approves device to help increase access to more lungs for transplant Federal Register: Administrative Detention and Banned Medical Devices