International safety notice
During an investigation by an overseas manufacturer, damage to the metal pins of the controller connector was confirmed. connectors and cables (battery, controller AC/DC adapter, or monitor data cable). When connecting the controller, the cable may gradually become loose due to forceful connection when the two parts are not aligned correctly. Similar connectors become worn out, and repeated similar connection operations can cause stress to the metal pins of the controller connector. It is thought that this may have caused damage. Recently, in order to change cable connectors to materials that are more durable against abrasion, some changes to approved items have been approved. Since we have obtained approval, we will carry out a voluntary recall to replace the existing product.
Japan / PMDA Recalls · JPN · Sep 25, 2023
Key facts
| Title | During an investigation by an overseas manufacturer, damage to the metal pins of the controller connector was confirmed. connectors and cables (battery, controller AC/DC adapter, or monitor data cable). When connecting the controller, the cable may gradually become loose due to forceful connection when the two parts are not aligned correctly. Similar connectors become worn out, and repeated similar connection operations can cause stress to the metal pins of the controller connector. It is thought that this may have caused damage. Recently, in order to change cable connectors to materials that are more durable against abrasion, some changes to approved items have been approved. Since we have obtained approval, 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 | CDC400412, BAT807141, CON020332, CDC401050, CON020041, BAT945103, BAT949091, BAT944721, CAC402942, CDC400963, BAT802162, BAT937902 and 3461 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