What happens to my 510k submission if the predicate is recalled?

Our team is preparing a 510(k) submission for a new patient monitoring device, and we’ve just learned that our chosen primary predicate has been subject to a Class II recall due to a specific design flaw affecting its alarm functionality. How does a predicate device recall impact a substantial equivalence argument, particularly when the recall relates directly to safety and performance? Can a device with a known design flaw still be used as a valid predicate, and if so, what level of justification is required to demonstrate that the new device does not share the same failure mode? For instance, if our new device was specifically engineered to overcome the exact issue that led to the recall, how should this be documented and presented in the 510(k) to strengthen the argument for substantial equivalence? Does the FDA expect a more rigorous side-by-side comparison or additional performance testing focused on the specific aspect that caused the predicate's recall? This situation raises a critical strategic question: is it better to address the recall head-on in the submission by demonstrating superior design, or is it safer to find an alternative, non-recalled predicate, even if it means re-doing comparative analysis?