Olympus Corporation of the Americas is recalling 989 units of the LithoCrushV Single Use Mechanical Lithotriptor V, Model Number BML-V442QR-30. This device is used with an endoscope to crush stones (calculi) inside the bile duct. The recall was initiated because the distal tip of the lithotriptor may tear during a procedure; no injuries have been reported to date.
If the tip of the device tears during a medical procedure, it could lead to the device failing to work as intended or fragments of the device being left inside the patient's bile duct. This could potentially require additional medical procedures to remove the fragments or complete the stone-crushing process.
Used with Olympus endoscope for crushing calculi inside the bile duct.
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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