International safety notice
Generic name: Prosthetic material for promoting embolization within the central circulatory system Sales name: OPTIMA coil system
Japan / PMDA Recalls · JPN · May 16, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Generic name: Prosthetic material for promoting embolization within the central circulatory system Sales name: OPTIMA coil system |
| Manufacturer | Century Medical Co., Ltd. |
| Models | F230800531, F230800824, F230800562, F230800798, F230800449, F230800901, OPTI0510CSFMX, OPTI0101CSS10, OPTI0358CSS10, F230800540, OPTI0102CSS10 |
| Date | May 16, 2025 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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