International safety notice
In some MOMA Ultra products, there is a mistake in pasting the seal on the inflation port, and the proximal valve It has been discovered that the inflation ports of balloons and distal balloons may not be correctly identified. As a result, we have decided to carry out a voluntary recall of products with specific lot numbers.
Japan / PMDA Recalls · JPN · Oct 13, 2023
Key facts
| Title | In some MOMA Ultra products, there is a mistake in pasting the seal on the inflation port, and the proximal valve It has been discovered that the inflation ports of balloons and distal balloons may not be correctly identified. As a result, we have decided to carry out a voluntary recall of products with specific lot numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: central circulatory system embolus capture catheter Sales name: MOMA Ultra |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 223676225, 224302454, 226008271, 226069364, 223172824, MUS0130069X6, 224141353, 223743827, 223323036, 224340223, 223190000, 223251143 and 30 more |
| Date | Oct 13, 2023 |
| 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