Medtronic Dialysis Catheter Recall Issued Over Risk of Leaks

Federal health officials have announced a Class I recall impacting more than 1 million Medtronic dialysis catheters, which may contain defects which allow the catheters to leak while in use, increasing the risk of blood clots and other serious adverse health consequences during hemodialysis treatments.

The Medtronic dialysis catheter recall was announced by the FDA on July 7, indicating that healthcare professionals should immediately stop using nine different models 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 serious and potentially life threatening outcomes.

The recalled catheters are most commonly used for hemodialysis treatments, in which the catheter is implanted under the skin into the patient’s veins to allow a dialysis machine to repeatedly filter and exchange blood to and from the body through separate catheter channels. However, Medtronic initiated the recall after becoming aware of a manufacturing design flaw which can create a potential leaking condition between the two channels, allowing liquid to be mistakenly returned through the wrong channel.

Although no reports of injury or deaths have been reported, officials warn that patients could experience 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.

Models impacted by the recall include 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.

On June 8, Medtronic sent a recall notice to all customers instructing them to discontinue using the impacted hemodialysis catheters and to immediately quarantine any remaining inventory until it can be returned to the manufacturer.

While Medtronic is not instructing medical professionals to remove or replace the catheters currently in use, medical professionals are being instructed to carefully monitor to make sure the devices are working as intended, and to report any adverse outcomes immediately to the manufacturer and the FDA.

Customers with questions concerning the catheter recall may contact their Medtronic Representative or call Customer Service at 800-962-9888. All adverse reactions or quality problems linked to the Medtronic catheters should be reported to the FDA’s MedWatch, Adverse Event Reporting Program.

2022 Medtronic Catheter Recalls

The dialysis catheter recall marks the third Medtronic catheter recall issued this year, following a Medtronic Harmony catheter recall in April and a Medtronic TurboHawk catheter recall in March, which, combined, impacted nearly 100,000 devices.

The Medtronic Harmony recall was announced 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 Medtronic TurboHawk catheter recall was announced 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.