International safety notice
General names: (1) Pressurizer for angiogenic balloons (2) Pressurizer for non-vascular balloons (3) Catheter for transdermal urinary urinary Sales name: (1)Inflation device Encore 26 (2)Encore 26 Inflation Device (3) Uromax Balloon Catheter
Japan / PMDA Recalls · JPN · Aug 5, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General names: (1) Pressurizer for angiogenic balloons (2) Pressurizer for non-vascular balloons (3) Catheter for transdermal urinary urinary Sales name: (1)Inflation device Encore 26 (2)Encore 26 Inflation Device (3) Uromax Balloon Catheter |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | 35277224, M00566670, 35547680, H74904526011, M0062251220, M0062251210, 35667483, 35065978, 34915076, 35257438, 35656798, 35045668 |
| Date | Aug 5, 2025 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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