International safety notice
Two reports from medical institutions have confirmed that certain lot numbers of the COOK Zenith Alpha Thoracic Endovascular Graft There is a possibility that the product is packed in a sheath with an inner diameter of 20 fr. (7.7 mm) instead of the specified 18 fr. (outer diameter 7.1 mm). Confirmed. We will voluntarily recall these products.
Japan / PMDA Recalls · JPN · Jan 25, 2023
Key facts
| Title | Two reports from medical institutions have confirmed that certain lot numbers of the COOK Zenith Alpha Thoracic Endovascular Graft There is a possibility that the product is packed in a sheath with an inner diameter of 20 fr. (7.7 mm) instead of the specified 18 fr. (outer diameter 7.1 mm). Confirmed. We will voluntarily recall these products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Aortic stent graft Sales name: COOK Zenith Alpha Thoracic Endovascular Graft |
| Manufacturer | Cook Medical Japan LLC |
| Models | E4281960, ZTA-DE-34-112-W1, E4281943, E4281944, E4281917, ZTA-P-34-161-W1, ZTA-P-38-217-W1 |
| Date | Jan 25, 2023 |
| 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