International safety notice
We received a report from a medical institution that the visual part was severed and remained in the body while using the product. As a result of comparing this product with conventional products, it was found that when the visible part of this product is subjected to repeated loads such as passing through a narrow curved flow path, We are conducting a voluntary recall of the affected products because we cannot deny the possibility that they may be disconnected if the product is damaged.
Japan / PMDA Recalls · JPN · Oct 16, 2023
Key facts
| Title | We received a report from a medical institution that the visual part was severed and remained in the body while using the product. As a result of comparing this product with conventional products, it was found that when the visible part of this product is subjected to repeated loads such as passing through a narrow curved flow path, We are conducting a voluntary recall of the affected products because we cannot deny the possibility that they may be disconnected if the product is damaged. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: central circulatory system microcatheter Brand name: Support Catheter SP |
| Manufacturer | JMS Co., Ltd. |
| Models | 18YP135H, 230605.10／230626.10／230807.10, 230529.10／230619.10／230710.10／230807.10, 18YP090H, 230424.10／230605.10／230626.10／230703.10／230717.10／230731.10, 230424.10／230612.10／230703.10／230731.10, 230424.10／230522.10／230605.10／230703.10／230710.10／230717.10／230724.10／230807.10, 230529.10／230619.10／230710.10／230731.10, 14YP090H, 18YP060H, 14YP110H, 230424.10／230612.10／230619.10／230724.10 and 2 more |
| Date | Oct 16, 2023 |
| 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