International safety notice
Medical institutions have reported multiple cases of leaks occurring from the connection between the rotator part of this product and the catheter. Through in-house verification, no leakage was confirmed under normal connection conditions, but under certain circumstances (when the connection between this product and the catheter was We were able to confirm leakage when force was applied from the side, such as when bending. Since the risk cannot be denied, we are implementing a voluntary recall of product lots starting from the one in which the leakage case was reported. I did it.
Japan / PMDA Recalls · JPN · Nov 15, 2022
Key facts
| Title | Medical institutions have reported multiple cases of leaks occurring from the connection between the rotator part of this product and the catheter. Through in-house verification, no leakage was confirmed under normal connection conditions, but under certain circumstances (when the connection between this product and the catheter was We were able to confirm leakage when force was applied from the side, such as when bending. Since the risk cannot be denied, we are implementing a voluntary recall of product lots starting from the one in which the leakage case was reported. I did it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Connector for catheters for balloon dilatation angioplasty Sales name: Cosmotech Connector |
| Manufacturer | Cosmotech Co., Ltd. |
| Models | 220916, 220803, 220819, CSM-001, 220905, 220627, 220722, 220909 |
| Date | Nov 15, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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