In February 2008, hospitals across the United States began seeing something that almost never happens with heparin, a blood thinner used in millions of procedures every year: patients going into sudden, severe allergic-type reactions — hypotension, nausea, shortness of breath — within minutes of receiving it. The FDA would eventually trace the cause to a contaminant called oversulfated chondroitin sulfate, added somewhere upstream in the crude heparin supply chain in China, a

For thirty years, "checking MAUDE" has been shorthand for post-market vigilance in the medical device industry. It is the database regulatory teams cite in literature searches, the tool clinical affairs pulls up before a submission, the first stop for anyone trying to understand how a device is behaving once it leaves the controlled world of a clinical trial and enters the far messier world of actual patients. By the end of May 2026, it will not exist in its current form.