International safety notice
An investigation by the overseas manufacturer confirmed an electrical failure in the battery. When the battery is electrically connected to the controller or charger, the mode settings of the software that controls the battery It is thought that the power supply and the electronic chip interact and generate overvoltage, causing electrical failure. Recently, in order to reduce the occurrence of this phenomenon, we have obtained approval for some changes to the approval items for batteries whose mode settings have been changed. Therefore, we will carry out a voluntary recall to replace the existing product.
Japan / PMDA Recalls · JPN · Sep 25, 2023
Key facts
| Title | An investigation by the overseas manufacturer confirmed an electrical failure in the battery. When the battery is electrically connected to the controller or charger, the mode settings of the software that controls the battery It is thought that the power supply and the electronic chip interact and generate overvoltage, causing electrical failure. Recently, in order to reduce the occurrence of this phenomenon, we have obtained approval for some changes to the approval items for batteries whose mode settings have been changed. Therefore, we will carry out a voluntary recall to replace the existing product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Implantable ventricular assist device system Brand name: Implantable ventricular assist device HVAD |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | BAT945147, BAT904471, BAT933657, BAT937286, BAT942027, BAT803585, BAT901398, BAT941125, BAT813299, BAT942256, BAT945982, BAT930125 and 2462 more |
| Date | Sep 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