Loading…
Insung Medical Co. Ltd. was cited for failing to comply with Medical Device Reporting (MDR) requirements for its ANKOR Endobronchial Tube, a life-supporting medical device. During an FDA inspection in April-May 2025, the company failed to report a device malfunction (carinal cuff inflation failure) within the required 30-calendar-day timeframe after becoming aware of information suggesting the malfunction could cause serious injury or death if it recurred. The company's failure to furnish required MDR information resulted in the device being deemed misbranded under federal law.