device recall
Regulatory action requiring manufacturer notification and potential device replacement due to safety or performance issues.
Full Definition
A device recall is a formal regulatory action initiated by manufacturers or regulatory agencies (such as the FDA) when implanted cardiac devices demonstrate safety concerns, performance failures, or manufacturing defects that could pose risks to patients. Recalls are classified by severity level and may require immediate device replacement, enhanced monitoring, or specific programming changes. The recall process involves comprehensive patient notification, physician communication, and detailed follow-up protocols. Recalls can significantly impact patient care decisions and may influence device selection for future implants. Healthcare providers must balance recall-related risks against the risks of device replacement surgery.
Usage
Usage note: Distinguish from 'device advisory' which may not require device replacement.
In Context
- "The device recall prompted immediate evaluation of all affected patients in the clinic." — Clinical advisory notification
- "Shared decision-making was used to discuss recall-related replacement options with the patient." — Physician consultation note