Pmda - Pharmaceuticals and Medical Devices Agency

Post-marketing Safety Measures

PMDA Alert for Proper Use of Medical Devices

“PMDA Alert for Proper Use of Medical Devices” aims to provide information to healthcare professionals in an easy-to-understand manner. The information presented here includes, among medical device malfunction/infection cases reported, such cases where the reporting frequencies of similar cases have not decreased in spite of the fact that precautions for those medical devices have been already issued in package inserts or in other ways.

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

  • Use in your own medical institutions, pharmacies, academic societies, or healthcare-related organizations, etc.
  • Use by the marketing authorization holders of medical devices or drugs related to “PMDA Alert for Proper Use of Medical Devices.”