International safety notice
For some Attain Balloon Catheter products, the raw materials used in the balloon are subject to manufacturing and sales approval. As it was discovered that there were discrepancies, we decided to carry out a voluntary recall of products with specific lot numbers.
Japan / PMDA Recalls · JPN · Feb 22, 2024
Key facts
| Title | For some Attain Balloon Catheter products, the raw materials used in the balloon are subject to manufacturing and sales approval. As it was discovered that there were discrepancies, we decided to carry out a voluntary recall of products with specific lot numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: central circulatory system angiography catheter Brand name: Attain Balloon Catheter |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 23K12844 |
| Date | Feb 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