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 Transjugular Intrahepatic Access Set is used for accessing the liver through the jugular vein for diagnostic and interventional procedures. Healthcare providers rely on this device for safe liver access in various medical scenarios.
The recalled devices may have been manufactured incorrectly, leading to improper lengths or insufficient inspection. This defect poses a serious risk during medical procedures, potentially resulting in complications.
This recall is not part of a broader industry pattern.
Consumers using this device face potential health risks that could lead to serious complications during medical procedures. Immediate action is necessary to ensure safety.
Serial numbers and lot numbers can typically be found on the packaging or directly on the device itself.
Refund processing timelines will be provided by Cook Medical upon contact.
Keep copies of all correspondence regarding the recall, including receipts and notification letters.
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.
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