Dialysis Catheter Recall Issued by Arrow International After Two Serious Injuries: FDA

Health care professionals are being advised to immediately stop using certain Arrow International dialysis catheter kits due to a design defect.

Federal officials are warning that defective Merit Medical Splittable Sheath Introducers included in certain Arrow International dialysis catheter kits may not split as intended when introduced into the patient’s vein, posing a risk of serious and potentially life-threatening injuries.

The U.S. Food and Drug Administration (FDA) issued the Arrow International dialysis catheter recall on April 24, warning that a design defect in the sheath introducers has been linked to at least two serious injuries.

A dialysis catheter kit is a sterile set of tools used to place a catheter into a vein so patients can receive hemodialysis when their kidneys are not working properly. The sheath introducer helps guide the catheter into the bloodstream and is designed to split during removal, allowing the catheter to remain in the vein while the guide sleeve is taken out.

However, if the introducer fails to split, removal can become difficult and increase the risk of complications such as hemorrhage, retained foreign material, procedural delays, embolism, impaired catheter function and loss of future vascular access sites.

The warning comes amid a growing number of port catheter lawsuits being filed against Bard and AngioDynamics, with each of the claims raising similar allegations that design flaws may allow the catheters to fracture or move within the body, increasing the risk of serious and potentially life-threatening complications such as infections, blood clots and other adverse outcomes.

Arrow International Dialysis Catheter Recall

The FDA is advising individuals not to use Merit Medical 16F Dual-Valved Splittable Sheath Introducers in the following Arrow International dialysis catheter kits and sets:

• Arrow Edge Hemodialysis Catheterization Product
• Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter
• Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter
• Cannon II Plus Chronic Hemodialysis Catheter
• NextStep Antegrade Chronic Hemodialysis Catheter
• NextStep Retrograde Chronic Hemodialysis Catheter

All affected customers were notified by letter in April and advised to immediately stop using or distributing the impacted kits and return them to Arrow International. 

Consumers in the U.S. who have experienced adverse reactions, quality issues, or have questions about the recall can contact Teleflex customer service, the parent company of Arrow International, at Recalls@teleflex.com or by calling 1-866-396-2111.

Health care professionals and patients can also submit reports of adverse events or product quality issues involving these devices through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

Catheter Device Failure Lawsuits

Beyond the Arrow International dialysis catheter recall, similar allegations have been raised in ongoing litigation involving other implantable port catheter devices.

More than 3,000 Bard PowerPort lawsuits have been filed nationwide, with plaintiffs alleging the catheters may deteriorate or fracture inside the body. Many of the claims focus on the use of barium sulfate within the catheter material, which is intended to make the device visible under imaging but is alleged to weaken the structure over time. According to the lawsuits, this can lead to cracking, fissures, and eventual fracture, increasing the risk of infection, blood clots, and the migration of broken fragments through the bloodstream, sometimes requiring emergency medical care.

Plaintiffs further allege that these microscopic cracks can harbor bacteria, contributing to persistent infections that may not be easily treated without removing the device.

Similar claims have also been brought in hundreds of cases involving AngioDynamics port catheters, where plaintiffs allege certain models contain design or manufacturing defects that can lead to device failure, often requiring corrective procedures or surgical removal.

Due to overlapping issues of fact and law, both groups of claims have been centralized into separate federal multidistrict litigations, or MDLs, by the U.S. Judicial Panel on Multidistrict Litigation (JPML), with each assigned to its own judge to oversee coordinated pretrial proceedings. 

As part of the MDL process, courts are moving forward with a series of “bellwether” trials, which involve a small number of representative cases selected to gauge how juries may respond to key evidence and arguments. While the outcomes are not binding on other claims, they often influence the direction of the litigation and potential settlement discussions.

If no global resolution is reached, individual cases may eventually be returned to their original courts for separate trials.

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