International safety notice
In overseas markets, cerebrospinal fluid leaked from the proximal part of the catheter (approximately 13 cm of stylet protrusion from the tip) during use. As a result of our investigation, we found that we cannot deny the occurrence of a similar event in products from a specific manufacturing period (batch). We have received a report from the overseas manufacturer stating that they have decided to recall the product. We have also decided to voluntarily recall the affected products distributed in Japan. There are no reports of this event occurring.
Japan / PMDA Recalls · JPN · Apr 17, 2024
Key facts
| Title | In overseas markets, cerebrospinal fluid leaked from the proximal part of the catheter (approximately 13 cm of stylet protrusion from the tip) during use. As a result of our investigation, we found that we cannot deny the occurrence of a similar event in products from a specific manufacturing period (batch). We have received a report from the overseas manufacturer stating that they have decided to recall the product. We have also decided to voluntarily recall the affected products distributed in Japan. There are no reports of this event occurring. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Catheter with transducer for intracranial pressure measurement Brand name: Sophysa Presio Catheter |
| Manufacturer | TKB Co., Ltd. |
| Models | 22C05550, 22C05549, 22C04771, 22C04398, 22C04770, 22C04343, 22C04397, 2C04403, 22C04396, 22C05442, 22D11663, 22C04399 and 6 more |
| Date | Apr 17, 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