International safety notice
In certain series, there is a risk that the stent cannot be deployed if there is severe bending or severe stenosis during placement. We have decided to voluntarily recall the product.
Japan / PMDA Recalls · JPN · Jul 5, 2023
Key facts
| Title | In certain series, there is a risk that the stent cannot be deployed if there is severe bending or severe stenosis during placement. We have decided to voluntarily recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: gastroduodenal stent Brand name: JLL gastroduodenal stent |
| Manufacturer | Japan Lifeline Co., Ltd. |
| Models | 2300254, 2300278, 2300046, 2300112, 2300005, 2300306, 2300446, 2300402, JD2212GS9, 2300010, 2300232, 2300233 and 162 more |
| Date | Jul 5, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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