International safety notice
We are conducting a voluntary recall of this product due to a continuing problem in which the coil detaches prematurely during the placement procedure.
Japan / PMDA Recalls · JPN · Dec 23, 2021
Key facts
| Title | We are conducting a voluntary recall of this product due to a continuing problem in which the coil detaches prematurely during the placement procedure. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Prosthetic material for promoting embolization in blood vessels of the central circulatory system Sales name: Allure-CS coil system |
| Manufacturer | Century Medical Co., Ltd. |
| Models | F210700887, F210800823, F210301345, F210800276, F210800715, F211100045, F210800227, F201200774, ALLU1240COM18, F210801110, F210800527, F210700304 and 185 more |
| Date | Dec 23, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1