Recall of Palindrome™ Precision Chronic Hemodialysis Catheters, Palindrome™ Chronic Hemodialysis Catheters and Mahurkar™ Chronic Carbothane Catheters

A Dear Healthcare Professional Letter has been issued by Medtronic International, Ltd to inform healthcare professionals of the recall of specific lots of the Palindrome^™ Precision Chronic Hemodialysis Catheters, Palindrome^™ Chronic Hemodialysis Catheters and Mahurkar^™ Chronic Carbothane Catheters. This followed a potential leaking condition identified within the hub of these catheters, where the flushing of one extension tube may result in unanticipated fluid return through the adjacent extension tube, in addition to the anticipated flow of fluid through the distal tip of the catheter. The potential leakage is due to an inter-lumen void formed in the hub component of the catheter during the manufacturing process. During use, this observed condition could translate to cross-communication of the blood circuit. Healthcare professionals are advised to discontinue use of the affected lots of chronic hemodialysis catheters and to return them to Medtronic. For patients with affected lots of chronic hemodialysis catheters currently in place, a replacement procedure may not be necessary. Clinicians are advised to continue to follow facility-specific policies and procedures for routine assessment of the hemodialysis access device for patency, function, and efficacy. To identify the potential interlumen communication of fluid, while flushing one extension tube, unanticipated simultaneous fluctuation of fluid in the adjacent extension tube is to be assessed by the clinician. If detected, the necessity and timing of a replacement catheter is to be determined by the patient’s medical team based on their clinical judgement. Please refer to the letter for details. Published: 17 Jun 2022

Dear Healthcare Professional Letters