Latest / Let's Talk Risk! Podcast
Case Study: The WATCHMAN TruSeal Recall and the Hidden Risk of Procedural Variation
In this audio brief, we unpack a recent Class I recalls of the Boston Scientific Watchman TruSeal Access System. What began as a rare but catastrophic risk of air embolism evolved into a global procedural-safety lesson for the entire MedTech industry.
Key themes:
* Procedural vs. device risk: How the true hazard emerged from workflow variation, not product failure.
* Scale-driven exposure: Commercial success amplified rare risks as adoption expanded to community hospitals.
* Narrative analytics: Text mining of MAUDE reports uncovered 43 % of events that structured codes missed - a…
The skinny
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