Cook Medical recalled 15 units of Transjugular Intrahepatic Access Sets on November 26, 2025. The devices may have been manufactured out of specification, leading to potential complications during medical procedures. Patients and healthcare providers should stop using these devices immediately.
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Letter
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The recall affects two model numbers: RTPS-100 and RTPS-100-10.0. These medical devices were distributed worldwide. Each unit is intended for transjugular liver access during diagnostic and interventional procedures.
Cook Medical identified that the affected products may have been cut to the incorrect length and not properly inspected. This issue poses a significant risk during medical procedures, potentially leading to complications.
No specific incidents of injury or death have been reported at this time. However, the manufacturing defects could lead to serious health risks.
Stop using the device immediately. Follow the recall instructions provided by Cook Medical. Contact your healthcare provider or Cook Incorporated for further guidance.
For more information, contact Cook Medical at the number provided in the recall notification letter.
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