The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.
A manufacturing error could cause chamber parts to split into layers and cause water to back up into the patient breathing circuit.
The Class I recall is a result of a mold overflow defect that could obstruct blood flow.
The corrective action is intended to reduce the risk of patient harm as a result of cybersecurity vulnerabilities in the products.
In the United States, nearly 4500 devices will be relabeled and 500 devices removed due to the risk of thrombus formation in the device.
This offending company has “significant” violations regarding reporting corrections and removals to FDA.
FDA has categorized the recall as Class I due to the seriousness of the device issue.
A malfunction can occur during improper exchange of the heart pump’s back-up system controller.
A vibration issue could cause the device to stop therapy.
The issue involves problems removing the balloon sheath during cardiac procedures.