International safety notice
Common Names: (1)(2) Implantable Cardiac Pacemaker (3) Implantable Biventricular Pacing Pulse Generator without Defibrillation Capability data Brand name: (1) Ingenio (approved and sorted) (2) Ingenio MRI (approved) (3) Invibe (approved and sorted)
Japan / PMDA Recalls · JPN · Dec 1, 2023
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Common Names: (1)(2) Implantable Cardiac Pacemaker (3) Implantable Biventricular Pacing Pulse Generator without Defibrillation Capability data Brand name: (1) Ingenio (approved and sorted) (2) Ingenio MRI (approved) (3) Invibe (approved and sorted) |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | 104734, 485669, 485302, 105299, 104659, 485353, 511665, 484061, 109041, 483149, 104523, 106303 and 4943 more |
| Date | Dec 1, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1,000+ Matching device models in FDA data
- 1,000+ Matching catalog numbers in FDA data
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