This webpage provides medical devices risk information which has come under review by the PMDA and MHLW. Information provided here is as follows:
Risk information which has attracted attention of foreign regulatory agencies or academic societies, for which the PMDA and MHLW have started their evaluation
Risk information which has attracted the attention of foreign regulatory agencies or academic societies based on studies published in scientific journals, etc., for which the PMDA and MHLW have started their evaluation since the risk information is related to medical devices marketed in Japan
Information provided here is still under review. If you are using the following medical devices, you should NOT stop using them without consulting a physician. Consult your healthcare professionals if you have any questions or concerns about these medical devices.
| Posted Date | Nonproprietary Name | Risk Information Ongoing Evaluation | Related Information | Investigation Results |
|---|---|---|---|---|
| February 18, 2021 | Drug-eluting stent for femoral artery Drug-coated balloon dilatation catheter |
Paclitaxel-coated Balloons and Stents in the Femoropopliteal Artery(2019.4.19) Paclitaxel-coated Balloons and Stents in the Femoropopliteal Artery(Update)(2021.2.18) Paclitaxel-coated Balloons and Stents in the Femoropopliteal Artery (Update) (2021.6.30) |
Information provided from US FDA (2019.1.17) Information provided from US FDA (2019.3.15) Information provided from US FDA (2019.8.7) Information provided from MHRA (2019.3.8) Information provided from MHRA (2019.6.4) Information provided from ANSM (2019.2.27) |
Notification on self-check |