International safety notice
Medical institutions in Japan have reported cases of leaks occurring from catheter hubs. It has been discovered that some products may have damaged hubs due to an issue. Since we cannot deny the possibility of this occurring, we have decided to implement a voluntary recall.
Japan / PMDA Recalls · JPN · Jul 12, 2022
Key facts
| Title | Medical institutions in Japan have reported cases of leaks occurring from catheter hubs. It has been discovered that some products may have damaged hubs due to an issue. Since we cannot deny the possibility of this occurring, we have decided to implement a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pulmonary artery catheter Brand name: Wedge pressure catheter |
| Manufacturer | Gadelius Medical Co., Ltd. |
| Models | 1005916, CI-220, CI-213F, 1006015, 1004166, 1007562, 1007568, 1007641, CI-219, 1006012, 1006013, 1004086 and 73 more |
| Date | Jul 12, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 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