Diversatek Healthcare has recalled approximately 2,175 Viper 3-Stage Balloon Dilators because the inflation tag attached to the catheter may list the wrong part number, diameter sizes, and inflation pressures for each stage. Using incorrect pressure settings during medical procedures could lead to improper dilation or device failure. No injuries have been reported to date, and the affected units were distributed across various U.S. states as well as Brazil and Belgium.
If a healthcare provider follows the incorrect pressure instructions on the device tag, they may inflate the balloon to an unsafe level or fail to reach the necessary diameter. This could result in serious complications during gastrointestinal dilation procedures, such as tissue damage or the balloon bursting.
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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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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