International safety notice
Recently, there have been several reports regarding vein graft anastomosis failure due to poor staple formation with this product during coronary artery bypass surgery. In order to prevent similar defects from spreading, overseas manufacturers have decided to voluntarily recall equipment manufactured at a specific time. did. We have decided to do so.
Japan / PMDA Recalls · JPN · Apr 1, 2021
Key facts
| Title | Recently, there have been several reports regarding vein graft anastomosis failure due to poor staple formation with this product during coronary artery bypass surgery. In order to prevent similar defects from spreading, overseas manufacturers have decided to voluntarily recall equipment manufactured at a specific time. did. We have decided to do so. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Non-absorbable vascular anastomotic coupler Sales name: PAS・Port System |
| Manufacturer | Century Medical Co., Ltd. |
| Models | 190627C, 200108B, 200304C, 52627199, 191014C, 200108F, 200108K, 190627G, FC700SU, 52624647, FG-000001, 190627E and 21 more |
| Date | Apr 1, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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