International safety notice
Some batches of this product may not meet design requirements, resulting in leakage from the balloon-to-catheter interface. Due to the risk of fluid leakage or the balloon separating from the catheter, we will voluntarily recall it.
Japan / PMDA Recalls · JPN · Nov 7, 2023
Key facts
| Title | Some batches of this product may not meet design requirements, resulting in leakage from the balloon-to-catheter interface. Due to the risk of fluid leakage or the balloon separating from the catheter, we will voluntarily recall it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: bile duct dilation catheter Brand name: COOK Quantum TTC balloon dilator for bile duct dilation |
| Manufacturer | Cook Medical Japan LLC |
| Models | W4722154, W4723311, QBD-10X3, W4750263, W4753363, W4754254, W4722645, QBD-8X3, W4752277, QBD-6X3, W4724319, W4722985 and 3 more |
| Date | Nov 7, 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