International safety notice
As a result of an investigation by the overseas manufacturer, some parts of the delivery system for this product (hereinafter referred to as "the product") It was discovered that there was a risk of the tapered tip (tip tip) breaking off during use, so parts with specific lot numbers were We will carry out a voluntary recall of the affected products manufactured using these products. We have not received any reports.
Japan / PMDA Recalls · JPN · Dec 24, 2021
Key facts
| Title | As a result of an investigation by the overseas manufacturer, some parts of the delivery system for this product (hereinafter referred to as "the product") It was discovered that there was a risk of the tapered tip (tip tip) breaking off during use, so parts with specific lot numbers were We will carry out a voluntary recall of the affected products manufactured using these products. We have not received any reports. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Aortic stent graft Brand name: ENDURANT II stent graft system |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | V30572362, V30547713, V30527865, V30575189, V30666342, V30608062, V30646521, V30538768, V30665508, V30603810, V30602137, V30538796 and 1261 more |
| Date | Dec 24, 2021 |
| 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