International safety notice
In certain lots of this product, the proximal marker attached to the shaft has moved from its installed position. A problem has been reported. Interventions or additional procedures, including surgery, may be required. To date, one case of additional coronary artery intervention has been reported. With this in mind, we have decided to carry out a voluntary recall of this product.
Japan / PMDA Recalls · JPN · Apr 12, 2022
Key facts
| Title | In certain lots of this product, the proximal marker attached to the shaft has moved from its installed position. A problem has been reported. Interventions or additional procedures, including surgery, may be required. To date, one case of additional coronary artery intervention has been reported. With this in mind, we have decided to carry out a voluntary recall of this product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Intravascular optical tomography catheter Brand name: Dragonfly Opstar OCT imaging catheter |
| Manufacturer | Abbott Medical Japan LLC |
| Models | 8256952, 8131362, 8131364, 8131360, 8220680, 8220681, 8211508, 8131365, 8211509, 8256954, 8131361, 8220686 and 7 more |
| Date | Apr 12, 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