PIDClass 2
Esophageal Dilator Balloon With Or Without Electrode Sensors
FDA adverse event reports and recall history for esophageal dilator balloon with or without electrode sensors (product code PID), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 146
- Deaths
- 1
- Injuries
- 30
- Malfunctions
- 115
Reports per year
219
420
1021
922
1023
8324
1925
926
Source: FDA adverse event reports by year received, 2019–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2024-06-07Open, ClassifiedNonconforming Material/Component
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
Monitor esophageal dilator balloon with or without electrode sensors automatically
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