International safety notice
An overseas manufacturer confirmed an error in the manufacturing process of measuring leaflet deflection during an internal inspection process. Due to this measurement error, some valves with deflection values outside of the specified values were shipped, and the affected products were subject to a voluntary review. I was informed that a collection would be made. After checking the history of imports and shipments to Japan, it was confirmed that 5 of the affected products had been shipped to Japan, so the product was recalled voluntarily. We have decided to implement the following.
Japan / PMDA Recalls · JPN · Oct 21, 2024
Key facts
| Title | An overseas manufacturer confirmed an error in the manufacturing process of measuring leaflet deflection during an internal inspection process. Due to this measurement error, some valves with deflection values outside of the specified values were shipped, and the affected products were subject to a voluntary review. I was informed that a collection would be made. After checking the history of imports and shipments to Japan, it was confirmed that 5 of the affected products had been shipped to Japan, so the product was recalled voluntarily. We have decided to implement the following. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Transcatheter bovine capsular valve Brand name: Navitor transcatheter bioprosthetic valve system |
| Manufacturer | Abbott Medical Japan LLC |
| Models | 20184552, 20190249, NVRO-27, 20183968, 20184675, 20184670 |
| Date | Oct 21, 2024 |
| 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