Catheter, Balloon Type
FDA adverse event reports and recall history for catheter, balloon type (product code GBA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 748
- Deaths
- 55
- Injuries
- 271
- Malfunctions
- 413
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-07-13TerminatedPackaging
27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.
Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.
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