International safety notice
A medical institution has instructed us to remove the dilator catheter from the delivery system's dilator catheter when placing this product's stent. I received information that the nectar had come off and the stent could not be placed. With this product, the stent can be placed by pulling out the dilator connector. As a result of the investigation, we found that there were variations in the connection strength between the dilator catheter and dilator connector, and products with low strength The resistance created during stent placement causes the dilator to move from the dilator catheter of the delivery system. It has been discovered that there is a possibility that the connector may become disconnected. We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Jan 25, 2023
Key facts
| Title | A medical institution has instructed us to remove the dilator catheter from the delivery system's dilator catheter when placing this product's stent. I received information that the nectar had come off and the stent could not be placed. With this product, the stent can be placed by pulling out the dilator connector. As a result of the investigation, we found that there were variations in the connection strength between the dilator catheter and dilator connector, and products with low strength The resistance created during stent placement causes the dilator to move from the dilator catheter of the delivery system. It has been discovered that there is a possibility that the connector may become disconnected. We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Biliary stent Brand name: (1) CX-T stent (2) Daimon T stent set |
| Manufacturer | Silx Co., Ltd. |
| Models | 22C1801, 21J2723, P-0712ST, 22F6105, 22F2152, 22F6117, 22F2132, 22F2172, 22C5805, 22B2405, 22F2116, 22F2188 and 75 more |
| Date | Jan 25, 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