International safety notice
Due to contact from the head office manufacturer, the English language affixed to the outer box and inner bag of this product. It was discovered that there was an error in the description of the French size of the outer diameter of the catheter on the label. Originally, the French size of the catheter outer diameter should be displayed as "5F" for all products, but The A4E01 was incorrectly displayed as "3F" and the A4E04 was incorrectly displayed as "4F". Due to the above reasons, we are implementing a voluntary recall of the product.
Japan / PMDA Recalls · JPN · Sep 6, 2022
Key facts
| Title | Due to contact from the head office manufacturer, the English language affixed to the outer box and inner bag of this product. It was discovered that there was an error in the description of the French size of the outer diameter of the catheter on the label. Originally, the French size of the catheter outer diameter should be displayed as "5F" for all products, but The A4E01 was incorrectly displayed as "3F" and the A4E04 was incorrectly displayed as "4F". Due to the above reasons, we are implementing a voluntary recall of the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: non-central circulatory embolus removal catheter Brand name: Python through lumen catheter |
| Manufacturer | Remate Vascular LLC |
| Models | PYT1020, PYT1023, PYT1066, PYT1051, PYT1067, PYT1055, A4E04, PYT1050, PYT1025, A4E01, PYT1019, PYT1021 |
| Date | Sep 6, 2022 |
| 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