International safety notice
The Woven EndoBridge device is used to place prosthetic materials (implants) for promoting endovascular embolization during endovascular embolization. The proximal end of the delivery pusher cannot be inserted into the insertion port of the product, and the Woven EndoBridge device We received information from a medical institution about a problem in which the implant cannot be removed. As a result of investigating this incident, we found that the dimensions of the insertion port of the product in question were manufactured to be smaller than the design control value, and the delivery date It turned out that the product was shipped in a way that the vise could not be inserted. We have decided to carry out a voluntary recall because the shipped products include products in a similar condition.
Japan / PMDA Recalls · JPN · Oct 24, 2022
Key facts
| Title | The Woven EndoBridge device is used to place prosthetic materials (implants) for promoting endovascular embolization during endovascular embolization. The proximal end of the delivery pusher cannot be inserted into the insertion port of the product, and the Woven EndoBridge device We received information from a medical institution about a problem in which the implant cannot be removed. As a result of investigating this incident, we found that the dimensions of the insertion port of the product in question were manufactured to be smaller than the design control value, and the delivery date It turned out that the product was shipped in a way that the vise could not be inserted. We have decided to carry out a voluntary recall because the shipped products include products in a similar condition. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Prosthetic material for promoting embolization in blood vessels of the central circulatory system Sales name: Woven EndoBridge withdrawal controller |
| Manufacturer | Terumo Corporation |
| Models | 0000142172, 0000166445, MV-WDC2 |
| Date | Oct 24, 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