Given Imaging Ltd. is recalling approximately 128,202 Bravo CF capsule delivery devices because adhesive was incorrectly applied during the manufacturing process. These devices are used by medical professionals to place and attach pH monitoring capsules to a patient's esophagus. The misapplied adhesive can cause the device to malfunction, potentially preventing the capsule from attaching to the esophagus or preventing it from detaching from the delivery tool.
The defect may lead to procedure failure if the monitoring capsule does not attach correctly, or it may cause the capsule to remain stuck to the delivery device, requiring additional medical intervention to resolve.
Units affected: 128,202 across both models.
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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