Catheter, Balloon, Transcervical

What the Data Shows About Catheter, Balloon, Transcervical

The FDA MAUDE database aggregates 753 adverse-event reports for Catheter, Balloon, Transcervical spanning the period from 1998 through 2016. Of these, 8 are classified as death reports, 298 as injury reports, and 418 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 12 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 1 distinct product-problem code appear in the reports, with Temperature Problem topping the list at 1 report. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 19 years of MAUDE data, with the peak single-year volume reaching 133 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 10 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on 2026-05-15. This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.