Final answer:
A recall of a medical device may be triggered by adverse event reports from health professionals or consumers, findings from FDA-mandated postmarket surveillance, or mandatory reporting of serious adverse experiences by the sponsor.
Step-by-step explanation:
After a processed medical device is released, several events can trigger a recall. These might include reports from health professionals or consumers to the FDA MedWatch program that indicate adverse events or malfunctions associated with the device, or findings from postmarket surveillance or additional clinical trials mandated by the FDA. If the Center for Devices and Radiological Health (CDRH) — the branch of the FDA responsible for medical device approval and oversight — identifies issues with device performance, safety, or manufacturing that pose a risk to patients, a recall may be initiated. Furthermore, if a sponsor learns about any adverse drug experiences or serious unexpected events associated with their product, they are required to report these to the FDA within stipulated timeframes, which could lead to a recall as well.