Covidien, LLC is recalling specific lots of the EsoFLIP 30mm Balloon Dilation Catheter (Ref ES-330) because of saline conductivity issues. These issues can cause the device to provide inaccurate measurements of the esophageal diameter during medical procedures. If a surgeon relies on these incorrect measurements, they may perform an improper dilation, which can lead to serious patient harm including esophageal injury. These medical devices were distributed worldwide between April 2022 and early 2024.
The catheters may report an incorrect diameter of the esophagus due to electrical conductivity problems with the saline solution used in the device. This measurement error could lead a physician to over-dilate or under-dilate the esophagus, potentially causing physical trauma, tears, or the need for additional corrective surgery.
Manufacturer notification and potential return
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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