International safety notice
Adhesion of guide wire lumens and Y-hubs observed during preparation or use in some lots of the product. An increase in the number of reports of balloon inflation failures due to leakage of expansion solution from the Ta. I made it clear. Ta.
Japan / PMDA Recalls · JPN · Jul 12, 2021
Key facts
| Title | Adhesion of guide wire lumens and Y-hubs observed during preparation or use in some lots of the product. An increase in the number of reports of balloon inflation failures due to leakage of expansion solution from the Ta. I made it clear. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Tubes and catheters for central circulatory system vascular procedures Brand name: Gore MOB balloon catheter |
| Manufacturer | Japan Gore LLC |
| Models | 23384093, 23224370, 23384491, 23384115, 22982070, 23224347, 23384097, 23384783, 23103047, 22982163, 23102378, 23384043 and 480 more |
| Date | Jul 12, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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