International safety notice
After investigating a complaint, a foreign manufacturer found that the COOK Zenith endovascular system for aortic dissection was manufactured in a gray color that was out of specification. We have started collecting the item because it may contain a positioner. We notified the medical institutions to which we delivered the product and began a voluntary recall of all unused products. The gray positioner is part of the delivery system.
Japan / PMDA Recalls · JPN · Jul 25, 2022
Key facts
| Title | After investigating a complaint, a foreign manufacturer found that the COOK Zenith endovascular system for aortic dissection was manufactured in a gray color that was out of specification. We have started collecting the item because it may contain a positioner. We notified the medical institutions to which we delivered the product and began a voluntary recall of all unused products. The gray positioner is part of the delivery system. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Aortic stent graft Brand name: COOK Zenith Endovascular System for Aortic Dissection |
| Manufacturer | Cook Medical Japan LLC |
| Models | E4193092, E3950841, E3922281, E4140878, E3918436, E4149943, E3892311, E3996156, E4213908, E4147619, E4147625, E4235327 and 1591 more |
| Date | Jul 25, 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