International safety notice
It is used to be placed in the bile duct for the purpose of dilating the bile duct or maintaining the lumen of the bile duct in areas of bile duct stricture. Approval is a successor approval in April 2023. Some of the knitting patterns have been changed. It was determined that no pharmaceutical procedures were required due to changes that did not affect the product's integrity, and it was distributed on the market without any pharmaceutical procedures. However, as a result of consultation with the Agency, it was determined that this change required a partial change application for approval. Therefore, we have decided to carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Oct 10, 2023
Key facts
| Title | It is used to be placed in the bile duct for the purpose of dilating the bile duct or maintaining the lumen of the bile duct in areas of bile duct stricture. Approval is a successor approval in April 2023. Some of the knitting patterns have been changed. It was determined that no pharmaceutical procedures were required due to changes that did not affect the product's integrity, and it was distributed on the market without any pharmaceutical procedures. However, as a result of consultation with the Agency, it was determined that this change required a partial change application for approval. Therefore, we have decided to carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Biliary stent Brand name: HILZO STENTS Bile duct covered stent |
| Manufacturer | MDI Japan Co., Ltd. |
| Models | 0122032, BVP0808HC, 01230131, BVP1007HC, 01230425, 01190625, 01211104, 01190313, 01200211, 01210729, 01220414, 01220712 and 82 more |
| Date | Oct 10, 2023 |
| 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