International safety notice
In response to reports that the X-ray opaque marker connected to the delivery pusher cannot be seen under X-ray fluoroscopy, As a result of an investigation at the manufacturer, we found that some products may have been caused by using the same material as the body coil during manufacturing. It has been found that the quality is high. We have decided to implement it.
Japan / PMDA Recalls · JPN · Apr 22, 2024
Key facts
| Title | In response to reports that the X-ray opaque marker connected to the delivery pusher cannot be seen under X-ray fluoroscopy, As a result of an investigation at the manufacturer, we found that some products may have been caused by using the same material as the body coil during manufacturing. It has been found that the quality is high. We have decided to implement it. |
|---|---|
| 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 | OPTI0306CSS10, F230800642, F230800640, OPTI0203CSS10, F230800636, OPTI0102CSS10, F230800641, OPTI0308CSS10 |
| Date | Apr 22, 2024 |
| 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