Olympus Corporation of the Americas is recalling 44,318 EZDilate Fixed Wire and Wire Guided Balloons because the devices may fail to inflate, deflate, or be retrieved during medical procedures. Reports indicate the balloons have burst or leaked, which can cause pieces of the device to remain inside the patient (foreign bodies) and lead to significantly prolonged medical procedures. These devices are used in adults and adolescents over 12 years old to widen narrowed sections of the esophagus or digestive tract. Consumers and healthcare providers should contact their manufacturer representative to manage affected stock.
If the balloon bursts or fails to deflate while inside a patient, it can leave fragments of the device behind or become stuck, requiring additional medical intervention to remove the debris and increasing the time a patient is under anesthesia.
Contact healthcare provider or manufacturer
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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