Medtronic Palindrome and Mahurkar Catheter Recall: Defect Could Cause Serious Injury or Death

The Medtronic Palindrome and Mahurkar catheter recall warns of the risk of blood clots and severe bleeding events

Federal safety officials indicate more than 1 million Medtronic hemodialysis catheters may leak while in use, increasing the risk of blood clots and other serious adverse health consequences during hemodialysis treatments.

The U.S. Food and Drug Administration (FDA) announced the Medtronic catheter recall on August 18, warning healthcare professionals to immediately stop using the dialysis catheters which may leak, causing a lack of clean blood being filtered back through the body.

Given the serious risk of injury posed by the catheters, the warning was classified by the FDA as a Class I recall, indicating the use of the products may cause severe and potentially life threatening outcomes.

Officials warn the devices contain a hub defect which connects both extension catheters, allowing a leaking condition which can return fluids through the wrong channel of the catheter. This defect may allow unanticipated fluid that has not been filtered to recirculate back into the patients’ bloodstream, resulting in poor dialysis and the potential for the patient to develop life threatening blood clots or experience severe bleeding events.

To date, officials have received at least one adverse event related to the recalled catheters. While no injuries or deaths have been reported, the FDA is instructing customers to immediately stop using the recalled catheters and to quarantine any remaining inventory.

The recall includes approximately 1,032,377 Palindrome and Mahurkar implantable catheters that are designed to be used for hemodialysis treatment, which is the practice of filtering waste and water from an individual’s blood. The devices are also approved for infusion and apheresis, which is a technology that separates the components of donated blood to treat certain conditions. It affects Palindrome and Mahurkar Hemodialysis Catheters manufactured by Covidien, LLC, a Medtronic subsidiary, from June 1, 2017 to April 1, 2022, which were distributed to hospitals and healthcare centers across the U.S. from June 28, 2017 to May 11, 2022.

Covidien sent an Urgent Medical Recall Letter on June 8, which instructs customers to immediately stop using the devices. Healthcare professionals are being instructed to use their clinical judgement in determining the necessity and timing of replacing the recalled catheters that are currently implanted in patients.

Customers with questions about this recall should contact Medtronic Technical Services at 1-888-826-5603 or email at rs.navtechsupport@medtronic.com. The FDA is asking that all adverse reactions or quality problems related to the devices be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Medtronic Catheter Recalls

In recent years, the FDA has issued dozens of catheter recalls over various manufacturing defects causing the tips of catheters to break off during procedures. Most of the recalls have been classified as a Class I recall by the FDA, indicating they are the most serious of their kind, and that the use of the products carry a high probability of severe patient injury or death.

Medtronic has been at the center of several major catheter recalls in recent years, with one of the most recent involving a different line of hemodialysis catheters. In July, another Medtronic Class I dialysis catheter recall was announced by the FDA, impacting more than one million Palindrome Precision, Palindrome Precision H, Palindrome Precision SI, Palindrome Precision HSI, Mahurkar Chronic Carbothane (Maxid) catheter and Palindrome Chronic catheters approved for use for acute and chronic hemodialysis, apheresis and infusions.

The recall warns the devices could leak while in use increasing a patient’s risk of developing blood clots or air bubbles in the veins and arteries which could lead to life-threatening complications such as a stroke or heart attack. The recall further warns patients could also suffer hemolysis; which is the breakdown or destruction of red blood cells, which can lead to fatigue, dizziness, and heart palpitations.

A Medtronic Harmony recall was announced in April following six reports of the capsules breaking away from the catheter, resulting in at least one injury. Officials warned patients could experience delays while the device is replaced with a new catheter, or require additional surgeries to retrieve the separated catheter tip. Officials warn patients could also experience severe or life threatening harm if the catheter capsule blocks blood flow or damages the patient’s blood vessels.

The FDA announced a Medtronic TurboHawk catheter recall in March after the manufacturer recognized the potential for the guidewire within the catheter to prolapse or move downward while normal force was being applied. Officials warned if this happens the tip of the catheter is prone to break off or separate, potentially resulting in serious injuries like arterial dissection (tearing the inside wall of an artery), ischemia (decrease in blood flow due to a blocked artery), and arterial rupture. Additional medical care, including surgical repair, could be needed to locate and remove the broken catheter tip.