International safety notice
Problems with balloons bursting, being damaged, not being able to inflate, leaking, and tearing have been confirmed in Japan and overseas. Ta. Ta.
Japan / PMDA Recalls · JPN · Oct 17, 2022
Key facts
| Title | Problems with balloons bursting, being damaged, not being able to inflate, leaking, and tearing have been confirmed in Japan and overseas. Ta. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) Non-central circulatory embolus removal catheter (2) Non-central circulatory embolus removal catheter (3) Stone extraction balloon catheter Brand name: (1) Fogarty catheter (2) Fogarty artery embolization removal catheter (3) Fogarty gallstone removal catheter |
| Manufacturer | Edwards Lifesciences Co., Ltd. |
| Models | 63325740, 63281616, 63301866, 63292039, 63420141, 63942919, 63358177, 120804FP, 64049164, 64368272, 63449651, 63669375 and 195 more |
| Date | Oct 17, 2022 |
| 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