International safety notice
A medical institution pointed out that the shape was different from the product specifications. When setting the product on the tray, it was discovered that the setting position was incorrect and the product had a shape that was different from the product specifications. I made it clear.
Japan / PMDA Recalls · JPN · Mar 11, 2022
Key facts
| Title | A medical institution pointed out that the shape was different from the product specifications. When setting the product on the tray, it was discovered that the setting position was incorrect and the product had a shape that was different from the product specifications. I made it clear. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiovascular catheter for pacing with balloon Brand name: Balloon catheter for bipolar pacing |
| Manufacturer | Goodman Co., Ltd. |
| Models | 21G08844, 606068 |
| Date | Mar 11, 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