Smiths Medical Port Catheter Recall Issued Over Manufacturing Error

Implantable port catheter’s housing can separate from the reservoir before, during or after implantation in patients.

Federal regulators are warning medical professionals and patients about a manufacturing defect with the Smiths Medical ProPort Catheter, following reports of at least two injuries linked to the totally implantable vascular access device (TIVAD).

The U.S. Food and Drug Administration (FDA) announced the Smiths Medical ProPort Port Catheter recall on March 19, due to the potential for the device’s housing and reservoir to separate from each other before, during or after implantation.

The ProPort catheter is a small device that is placed under the patient’s skin to assist in the routine delivery of medication and fluids during medical procedures, such as blood transfusions or chemotherapy.

These types of implantable ports are widely used to reduce the need for frequent needle sticks in patients undergoing regular treatments. However, in recent years, several port catheter devices have been linked to serious and life-threatening injuries due to design and manufacturing flaws.

Specifically, implantable ports manufactured by Bard and AngioDynamics have been linked to a series of port catheter injuries, allegedly caused by the use of barium sulfate, which can break down over time and allow the catheters to fracture, migrate or harbor bacteria that can lead to the development of bloodstream infections. 

As a result, a series of  Bard PowerPort lawsuits and AngioDynamics port catheter lawsuits have been filed in recent years, each raising allegations that the manufacturers were well aware of the port catheter fracture, migration and infection risks, yet failed to issue a recall, or disclose the risks to patients or the medical community.

The Smiths Medical ProPort recall was issued by the manufacturer on February 13, following reports of at least two injuries due to a manufacturing defect that caused the port housing to separate from the port reservoir. There is no indication at this time that the problems are the result of design defects.

The manufacturer warns that use of the recalled port catheters could lead to a number of adverse health consequences, including delay or interruption of medication delivery, damage or scarring of the skin tissue from contact with leaking medications, air entering the bloodstream, and even death.

A full list of affected devices, including item numbers, product names and Unique Device Identifiers is available in the FDA’s recall notice.

Providers are advised not to use any of the affected devices, and to monitor patients who have already had ProPort port catheters implanted for symptoms such as swelling, redness or discomfort at the implantation site.

The manufacturer advises hospitals to check their inventory, quarantine, and return affected products, and notify patients of the recall. A response form must be emailed to smithsmedical8171@sedgwick.com within 10 days, even if no affected products are found. Facilities without a recall letter can request a form by calling 1-888-345-2656. For questions, U.S. customers can contact Smiths Medical at customerservice@icumed.com or 1-800-258-5361.

Bard PowerPort Lawsuits

While the Smith Medical ProPort recall was linked to manufacturing issues, similar port catheter problems associated with certain Bard PowerPort products have resulted in a number of lawsuits over the past few years, involving allegations that the composition of these implantable ports can cause the catheter to fracture, migrate, or fail, resulting in complications such as infections, blood clots and organ damage from migrated catheter fragments.

There are currently at least 1,000 Bard PowerPort lawsuits pending in the federal court system, which have been centralized as part of an MDL (multidistrict litigation), which is being overseen by the U.S. District Judge David G. Campbell in the District of Arizona.

As part of the coordinated management of this litigation, Judge Campbell has directed the parties to prepare a small group of representative claims for early trial dates, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the claims.

During a conference last month, the Court directed parties to file a joint memorandum, detailing timelines for preparing the first Bard PowerPort lawsuits for ”bellwether” trials, along with expert witness challenges and summary judgment motions.

While the outcomes of these bellwether trials will not have any binding impact on other claims pending in the Bard PowerPort MDL or state courts, they will be closely watched by lawyers involved in the litigation, as the average jury awards could have a major impact on any potential global Bard PowerPort lawsuit settlements. 

AngioDynamics Port Catheter Lawsuits

In addition to the lawsuits filed against Bard over its PowerPort devices, similar design problems have resulted in at least 120 AngioDynamics port catheter lawsuits being brought against AngioDynamics Inc. and Navilyst Medical Inc.

Similar to the PowerPort litigation, each of the AngioDynamics lawsuits filed throughout federal courts have been consolidated for pretrial proceedings. However, the AngioDynamics MDL has been centralized in the Southern District of California under U.S. District Judge Jinsook Ohta.

Judge Ohta is also expected to implement a bellwether trial process to assess potential jury verdicts. While these early trials will not directly impact other cases, they may facilitate a global settlement. If no agreement is reached, individual cases may be sent back to their original U.S. District Courts for trial.