Real-world perspectives on device safety and surveillance
We analyze FDA adverse event data to surface the trends, safety signals, and regulatory intelligence that matter to medical device professionals.
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Evolut FX Transcatheter Aortic Valve Reports: What MAUDE Data Reveals About Safety Signals
MAUDE reports filed on Medtronic's Evolut FX TAVR system since 2019. Analysis of deaths, injuries, recalls, and clinical outcomes.
READWatchman Device Reports to FDA: What the MAUDE Data Reveals About Boston Scientific's Leading LAA Closure Device
Analysis of 10,998 FDA MAUDE reports on the Watchman device from Boston Scientific, including 1,210 deaths and emerging safety signals.
READImpella in MAUDE: 39,275 Adverse Event Reports and a Recall Cluster That Is Still Growing
A quantitative look at Abiomed's Impella heart pump using seven years of FDA adverse event data, the 2023-2026 reporting surge, seven open Class I recalls, and the active surveillance signals that are still firing in 2026.
READThe HVAD in MAUDE: 49,000 Adverse Event Reports on a Withdrawn Heart Pump
A quantitative retrospective on Medtronic's HeartWare HVAD using five years of public FDA adverse event data, including the failure-mode signature that was visible in MAUDE before the 2021 market withdrawal.
READHow to Search the FDA MAUDE Database (and What It Won't Tell You)
Step-by-step: how to search the FDA MAUDE database by brand, manufacturer, or product code, the fields that matter, and what raw MAUDE counts won't tell you.
READSignal Detection in Post-Market Surveillance Is Broken: Here’s Why
Most medical device signal detection systems fail in practice. This article explains why MDR-based surveillance breaks down, and what a modern, data-driven approach should look like.
READPost-Market Surveillance in the United States: The System We Have vs. the System We Need
Post-market surveillance in the U.S. is more than MDR reporting. This deep dive explains how FDA requirements actually work in practice—and where the system breaks down.
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