In June 2022, Medtronic’s subsidiary, Covidien, LLC, recalled Palindrome and Mahurkar Hemodialysis Catheters due to a catheter hub defect. The U.S. Food and Drug Administration (FDA) classified the recall as a Class 1 recall. Class 1 recalls are the most serious type of recalls and the use of these devices can cause serious injuries or even death. Over one million devices in the United States were included in the recall. The affected devices were distributed from June 28, 2017, through May 11, 2022.
Palindrome and Mahurkar Hemodialysis Catheters are implanted and used in hemodialysis (treatment to filter waste and water from a patient’s blood), apheresis (technology that separates donated blood components to treat certain illnesses), and infusion (putting fluids into the bloodstream). The catheter is placed under the skin to take out blood through one tube and then return the cleaned blood back to the body through a different tube. However, the malfunction can occur due to an empty space between the device’s two channels (known as lumens) in the hub of the catheter where they meet. This could lead to the cross-contamination of the blood. Therefore, flushing one tube could cause liquid to be sent back through the other tube.
The malfunction could potentially cause the catheters to leak while in use. The potential leaking could lead to increased recirculation, poor dialysis, or the development of thrombi and emboli. Thrombi (thrombosis) occurs when a thrombus (also known as a blood clot) develops in a blood vessel and reduces blood flow. An emboli (embolism) occurs when a piece of a blood clot, foreign object, or other bodily substance gets stuck in a blood vessel and obstructs blood flow.
Using a defective catheter can be extremely dangerous and cause serious complications such as bleeding, surgical removal, and replacement of the malfunctioning catheter.
At this time, there has been one reported complaint, but no reports of injuries or death.
How GoldenbergLaw Can Help YouIf you or a loved one were injured by a defective hemodialysis Catheter, contact the Medical Device Attorneys at GoldenbergLaw. Medical device lawsuits are complex, and you need a team that has the experience, expertise, and compassion to get you the justice you deserve. The GoldenbergLaw team has more than 35 years of providing clients with the Gold standard of advocacy. Contact us today to learn how we can help you!