International safety notice
A component of a sheath assembly for percutaneously delivering a snare (wire tube assembly) into a blood vessel. Because the raw materials for the Luer Lock adapter were incorrectly listed on the approval form, we have decided to voluntarily recall all products within the expiration date. That's what I said.
Japan / PMDA Recalls · JPN · Apr 11, 2024
Key facts
| Title | A component of a sheath assembly for percutaneously delivering a snare (wire tube assembly) into a blood vessel. Because the raw materials for the Luer Lock adapter were incorrectly listed on the approval form, we have decided to voluntarily recall all products within the expiration date. That's what I said. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: central circulatory system embolization catheter Sales name: COOK Indy OTW Vascular Retriever |
| Manufacturer | Cook Medical Japan LLC |
| Models | 14431303, 14494932, 15757953, 15113979, 14372453, 14365560, 14267196, 15117647, 14287514, 14303672, INDY-8.0-35-100-40, 15599018 and 133 more |
| Date | Apr 11, 2024 |
| 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