International safety notice
General name: Implantable Auxiliary Artificial Heart System Sales name: Implantable Auxiliary Artificial Heart EVAHEART
Japan / PMDA Recalls · JPN · Jul 30, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General name: Implantable Auxiliary Artificial Heart System Sales name: Implantable Auxiliary Artificial Heart EVAHEART |
| Manufacturer | Sun Medical Technology Research Institute, Inc. |
| Models | CT310-5041, CT310-5040, CT310, CT310-5037, CT310-5036, CT310-5027, CT310-5028, CT310-5039, CT310-5038, CT310-5006, CT310-5007, CT310-5005 and 18 more |
| Date | Jul 30, 2025 |
| 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