International safety notice
General name: Implantable Auxiliary Artificial Heart System Sales name: (1) Implantable artificial heart, HeartMate II (2) Implantable artificial heart, HeartMate3
Japan / PMDA Recalls · JPN · Mar 17, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General name: Implantable Auxiliary Artificial Heart System Sales name: (1) Implantable artificial heart, HeartMate II (2) Implantable artificial heart, HeartMate3 |
| Manufacturer | Abbott Medical Japan LLC |
| Models | 20314689, 20326983, 20293154, 20326981, 20327004, 20314684, 107754, 20326960, 20326949, 20314693, 20327003, 20293155 and 73 more |
| Date | Mar 17, 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