International safety notice
We have received information from a medical institution that this product's stent may enter the bile duct after placement. The papillary side flap of the stent reduces the possibility of the stent straying into the bile duct. It was found that this was not sufficient to prevent the substances from entering the bile ducts, and that there was a possibility that they could actually enter the bile ducts. did. Therefore, we have decided to voluntarily recall the affected lots that were shipped.
Japan / PMDA Recalls · JPN · Apr 4, 2023
Key facts
| Title | We have received information from a medical institution that this product's stent may enter the bile duct after placement. The papillary side flap of the stent reduces the possibility of the stent straying into the bile duct. It was found that this was not sufficient to prevent the substances from entering the bile ducts, and that there was a possibility that they could actually enter the bile ducts. did. Therefore, we have decided to voluntarily recall the affected lots that were shipped. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Biliary stent Brand name: UMIDAS NB stent |
| Manufacturer | UMIDAS Co., Ltd. |
| Models | 22E518, 22E1149, 4S250713TB, 22E5133, 21L4120, 22A4537, 22D4446, 22A051, 21G1554, 22E5149, 22D4109, 22E5185 and 322 more |
| Date | Apr 4, 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