International safety notice
As a result of an investigation by an overseas manufacturer, it was found that an excessive amount of polyurethane adhesive was applied to fix the ring electrode of the product. As it was discovered that the product may have been manufactured, we will conduct a voluntary recall of the product distributed in Japan. That's it.
Japan / PMDA Recalls · JPN · May 16, 2024
Key facts
| Title | As a result of an investigation by an overseas manufacturer, it was found that an excessive amount of polyurethane adhesive was applied to fix the ring electrode of the product. As it was discovered that the product may have been manufactured, we will conduct a voluntary recall of the product distributed in Japan. That's it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiovascular catheter for ablation Brand name: VARIPULSE pulse field ablation catheter |
| Manufacturer | Johnson & Johnson Co., Ltd. |
| Models | 31184089L, 31178675L, D141201, 31182580L, 31178679L, 31178676L, 31178678L, 31178677L |
| Date | May 16, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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