International safety notice
It has been discovered that some of the balloon compliance charts included in the package insert are incomplete. We have decided to voluntarily recall all LOTs of recalled products in order to replace the package inserts.
Japan / PMDA Recalls · JPN · Jun 10, 2021
Key facts
| Title | It has been discovered that some of the balloon compliance charts included in the package insert are incomplete. We have decided to voluntarily recall all LOTs of recalled products in order to replace the package inserts. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Balloon-expandable valvuloplasty catheter Brand name: NuMED valve dilation catheter |
| Manufacturer | Tritec Co., Ltd. |
| Models | TH-38688, TH-38237, TH-37554, TH-36826, TH-29384, TH-27761, TH-35986, TH-28815, TH-33744, TH-33742, TH-27764, TH-33540 and 73 more |
| Date | Jun 10, 2021 |
| 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