Trokamed GmbH is recalling 231 units of its Gastro-Urology Endoscopic Sheaths (Access Overtubes) because of a defect that can cause dangerous pressure buildup in the kidney. If fluid is pumped into the kidney too quickly, the device may fail to let it flow back out if blood, tissue, or stone fragments are present. There have been no reports of injuries or incidents to date, but the manufacturer is voluntarily recalling the devices to prevent potential harm during surgery.
Blocked outflow through the device shaft can lead to a rapid increase in intrarenal pressure, which may cause serious internal injury to the patient during endoscopic procedures.
Recall #: Z-0713-2025
Recall #: Z-0714-2025
Recall #: Z-0715-2025
Recall #: Z-0716-2025
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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