International safety notice
When an overseas manufacturer conducted a verification test on the inflation pressure of the balloon of the product, it was found that in a particular lot, the maximum inflation pressure It has been discovered that some balloons break when pressurized below this pressure. Since we cannot deny the possibility that the product may have been shipped, we have decided to carry out a voluntary recall of the product.
Japan / PMDA Recalls · JPN · Sep 26, 2024
Key facts
| Title | When an overseas manufacturer conducted a verification test on the inflation pressure of the balloon of the product, it was found that in a particular lot, the maximum inflation pressure It has been discovered that some balloons break when pressurized below this pressure. Since we cannot deny the possibility that the product may have been shipped, we have decided to carry out a voluntary recall of the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Balloon-expandable angioplasty catheter Brand name: Chameleon PTA balloon catheter |
| Manufacturer | Covidien Japan Co., Ltd. |
| Models | CH05-40-75US, 22203055, 22300966, 22201871, 22202428, 22202646, 22201785, 22300151, 22203026, CH06-40-75US, 22201337, 22201047 and 16 more |
| Date | Sep 26, 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