International safety notice
There have been reports from medical institutions of poor balloon expansion and deflation. After investigating the manufacturer, it was discovered that they may have shipped a product that had a problem with the processing of the catheter lumen. We will carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Dec 4, 2023
Key facts
| Title | There have been reports from medical institutions of poor balloon expansion and deflation. After investigating the manufacturer, it was discovered that they may have shipped a product that had a problem with the processing of the catheter lumen. We will carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) Esophageal balloon catheter, (2) Endoscopic dilation catheter, (3) Bile duct dilation catheter Brand name: (1) Esophageal balloon dilator (2) Balloon dilator for gastrointestinal tract (3) Balloon dilator for biliary tract |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Models | BD-420X-1555, 377813, BD-400P-2080, 364158, BD-430X-1855, 377811, 382351, BD-420X-2055, 376885, 374099, 388173, 388460 and 30 more |
| Date | Dec 4, 2023 |
| 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