PMDA Alert for Proper Use of Medical Devices

“PMDA Alert for Proper Use of Medical Devices” aims to communicate to healthcare providers with clear information. The information presented here includes such cases where the reporting frequencies of similar reports have not decreased despite relevant alerts provided in package inserts, among medical device failure/infection cases reported.
 

No.	Posted on	Title
3	March 2022	Bleeding Caused by the Use of IMPELLA Circulatory Assistance Pump Catheter
2	July 2018	Adverse Events involving the Use of Bioprostheses for Transcatheter Aortic Valve Implantation
1	July 2017	Adverse Events Associated with the Use of Aortic Stent-Grafts

 

Considerations for using "PMDA Alert for Proper Use of Medical Devices"

Any action related to reproduction, reprint, and distribution, etc. without our permission is prohibited regarding the PMDA Alert for Proper Use of Medical Devices except for following cases.

• Use in your own medical institutions, pharmacies, academic societies, or healthcare-related organizations, etc.
• Use by manufacturers who provide medical devices or medicines related “PMDA Alert for Proper Use of Medical Devices.”

The information above is English translation of the "PMDA Alert for Proper Use of Medical Devices."

In the event of inconsistency, the text in Japanese shall prevail.