Palindrome, Mahurkar hemodialysis catheters recalled due to defect
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The FDA announced Covidien LLC, also known as Medtronic, recalled the Palindrome and Mahurkar hemodialysis catheters due to a defect in the catheter hub.
Further, the FDA has announced this is a Class I recall, “the most serious type of recall.”
The 1,032,377 recalled catheters were manufactured between June 1, 2017, and April 1, 2022, and then distributed between June 28, 2017, and May 11, 2022.
According to the FDA press release, the defect in the catheter hub can lead to leaking, which is identified when flushing one extension tube. If a leak occurs, the arterial and venous blood could potentially mix and lead to increased recirculation, poor dialysis and the development of thrombi and emboli.
In total, there has been one complaint and no reports of death or injury.
Covidien LLC recommended affected customers should quarantine and discontinue use of recalled catheters. Those with the specified catheter should return them, notify recipients of catheters and complete the Consignee Product Retrieval Confirmation Form even if one does not have unused inventory.
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