If a device failure occurs more frequently than expected and is tied to improper use, what typically occurs?

When a device failure occurs more frequently than expected and is linked to improper use, the typical response is to revise the labeling. This adjustment is crucial as it can provide clearer instructions and warnings to help ensure that users understand how to operate the device safely. By revising the labeling, manufacturers can mitigate the risks associated with improper use, leading to improved patient safety and reduced incidents of failure. This proactive measure communicates important information regarding the correct usage, thereby reducing the likelihood of future issues stemming from user error.

In contrast, options like recalling the product or redesigning it are more drastic steps usually considered when the device itself has inherent flaws or is unsafe, rather than when the issue is associated with user application. Issuing a "Dear Doctor" letter is an approach often utilized to communicate critical information to healthcare providers, but it may not directly address the root of improper usage as effectively as revising the labeling would. Therefore, refining the labeling stands out as the most appropriate action in this scenario.