Health Canada — Medical Devices · Canada · 2018-04-24 · Type II
As described by Health Canada — Medical Devices: On-X Conform-X Prosthetic Heart Valve - Aortic with Extended Valve Holder, Mitral, Aortic and On-X Prosthetic Heart Valve - Aortic, Mitral, On-X Prosthetic Heart Valve - Aortic with Extended Valve Holder, and On-X Aortic Prosthetic Heart Valve with A...
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Reported risk: The Medicines & Healthcare products Agency (MHRA) became aware of five (5) incidents worldwide over the last fifteen (15) years where mechanical bileaflet prosthetic valves were reported to have been implanted in an inverted position because they were put in their holder upside down. The 5 reported incidents were not associated with On-X heart valves. To date, On-X Life Technologies, Inc. has received one related report. No Product is subject to removal or correction in the field. A field safety notice will be transmitted to all relevent personnel who handle and implant the On-X Valve Device.
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