International safety notice
It has been reported that excessive inflation of the cuff of this product caused cuff pressure to rise, resulting in obstruction of the product, airway obstruction, and poor ventilation. The notification has been confirmed overseas. Oxygen saturation, hypoxia, respiratory distress, abnormal blood gas measurements, cyanosis, apnea, respiratory arrest, cardiac arrest, brain injury, etc. In response to reports of health damage or death occurring in patients, we have taken measures to prevent health damage to patients. Therefore, we will carry out a voluntary recall of the affected products.
Japan / PMDA Recalls · JPN · Jul 9, 2024
Key facts
| Title | It has been reported that excessive inflation of the cuff of this product caused cuff pressure to rise, resulting in obstruction of the product, airway obstruction, and poor ventilation. The notification has been confirmed overseas. Oxygen saturation, hypoxia, respiratory distress, abnormal blood gas measurements, cyanosis, apnea, respiratory arrest, cardiac arrest, brain injury, etc. In response to reports of health damage or death occurring in patients, we have taken measures to prevent health damage to patients. Therefore, we will carry out a voluntary recall of the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Electromyograph electrode Sales name: EMG tube |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 0224387286, 0228251897, 0225525311, 0221849460, 0226945351, 0226795824, 0225580854, 0223694051, 0225737410, 0227644678, 0224890605, 0221832721 and 38 more |
| Date | Jul 9, 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