International safety notice
At an overseas manufacturer, some lots of "Rotor Wire Drive" have weak seals in sterilized packaging. It has been confirmed that there is a possibility that We have decided to voluntarily recall certain lots of this product. Did.
Japan / PMDA Recalls · JPN · Mar 8, 2022
Key facts
| Title | At an overseas manufacturer, some lots of "Rotor Wire Drive" have weak seals in sterilized packaging. It has been confirmed that there is a possibility that We have decided to voluntarily recall certain lots of this product. Did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac/Central Circulatory System Catheter Guidewire Brand name: Rotor wire drive |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | 27792970, 27756205, 27826576, 27826574, 27756935, H74939462005, 27632712, 27701910, 27706785, 27749754, 27804244, 27756019 and 12 more |
| Date | Mar 8, 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