November 2015 MedSun Newsletter
Recalls and Safety Alerts:
Cranial Perforators With an Automatic Clutch Mechanism: Safety Communication
This clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use...
PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 by MicroPort Orthopedics: Class I Recall
MicroPort Orthopedics Inc. has received reports of an unexpected rate of fractures after surgery related to this specific modular neck...
Bioprosthetic Aortic Valves: FDA Notification - Reduced Leaflet Motion
FDA is aware of recent reports regarding reduced leaflet motion in some bioprosthetic aortic valves, including both SAVR and TAVR devices. Importantly, most cases of reduced leaflet motion were discovered by advanced imaging studies in patients without symptoms of abnormal bioprosthetic valve function...
Infections Associated with Reprocessed Duodenoscopes
The FDA has ordered manufacturers of duodenoscopes sold in the U.S. to conduct postmarket surveillance studies to better understand how their duodenoscopes are reprocessed in real-world settings...
Heater-Cooler Devices: FDA Safety Communication
FDA is aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures...
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