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 turned out that the part may be defective. There is a risk that the stent graft will fail to expand during placement. As of October 12, 2021, we have received one report of this event occurring overseas. Stent-grafts that sometimes malfunction can be finally deployed without any health hazards to the patient. It was. It was recognized that it was out of line. We will voluntarily recall some products with serial numbers manufactured using. No report has been received.
Japan / PMDA Recalls · JPN · Oct 19, 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 turned out that the part may be defective. There is a risk that the stent graft will fail to expand during placement. As of October 12, 2021, we have received one report of this event occurring overseas. Stent-grafts that sometimes malfunction can be finally deployed without any health hazards to the patient. It was. It was recognized that it was out of line. We will voluntarily recall some products with serial numbers manufactured using . No report has been received. |
|---|---|
| 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 | ETTF2828C70EJ, V30616748, V30624649, V30616746, V30616743, ETUF2314C102EJ, V30623217, ESBF2814C103EJ, ETTF2323C70EJ, V30629693, V30629692, V30629694 |
| Date | Oct 19, 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