Defective Catheter Recalls and Catheter Lawsuits

Millions of catheters have been recalled over the past few years by medical device manufacturers and the FDA after receiving reports of serious health complications linked to catheter device failure. Subsequently, lawyers have been investigating complaints and defective catheter lawsuits have been filed. Among issues cited in the recalls are catheter separation and breakage. Most all catheter recalls are designated Class1, the most severe type of recall indicating the product may cause serious injuries such as perforation of blood vessels and even death.

Catheter Device Failure

A catheter is a thin, flexible tube inserted through a narrow opening into the body via a cavity, duct or blood vessel. Numerous types of catheters are used in medical procedures, with urinary catheters—which are used to empty the bladder and collect urine in a drainage bag—being the most familiar. Catheters are made from medical-grade materials, come in a variety of sizes, and serve many functions, including:

• Administering of fluids: Some catheters allow doctors to administer intravenous fluids or medications, such as injecting contrast dye for angiogram procedures.
• Drainage of fluids: A urinary catheter drains urine from the body, whereas a different type of catheter may drain fluid from an abscess.
• Breathing tubes: Some catheters used as breathing tubes administer oxygen and other breathing gases.
• Subcutaneous catheters are placed under the surface layer of the skin and administer medications like insulin pumps.
• Cardiac treatments:  blood vessels that are narrowed or blocked, may be treated with medical devices that include catheters.

The PowerPort belongs to a category called port/catheter systems. Surgically inserted beneath the skin, it delivers medication, intravenous fluids, blood products, and parenteral nutrition solutions directly into the bloodstream and stays implanted within the patient.

It comprises two parts: an injection port and a polyurethane catheter. The injection port, characterized by a raised center or “septum,” is where the needle is inserted to deliver medication. From here, the medication travels through a flexible tube, the catheter, and enters the bloodstream.

Totally implantable vascular access devices (TIVADs), also known as port catheters or port a caths, are frequently used for venous access during long-term therapy, such as chemotherapy ports and dialysis ports. But increasing evidence indicates that certain designs may pose a much greater risk of TIVAD problems, and device makers have failed to warn patients or the medical community of potential risks.

Implantable central venous catheters are implanted in the chest or near the neck to provide long-term access to major veins to allow for repeated drawing and/or delivery of fluids, medications and/or nutrients. These devices are common in cancer patients who require repeat chemotherapy treatments, as well as in patients with severe autoimmune disorders. These implantable central venous catheters include such brands as:

• PowerPort
• PowerFlow
• PowerHickman
• X-Port
• SlimPort
• BardPort
• Titanium

CATHETER DEVICE FAILURE

A defective catheter may not function properly and not drain fluids or administer medication as designed, causing serious health problems. When catheters are inserted or used improperly, they can get stuck in the body, causing cuts, bruises, scars and bleeding. A defective catheter may cause injury to the patient if:

• the catheter itself is defective and doesn't function properly;
• healthcare professionals fail to notice the warning signs that a catheter is not functioning properly;
• the catheter is inserted or used improperly.

Numerous catheters have been recalled over the past few years due to problems such as:

• Breaking
• Tip breaks off
• The tip is left behind in the patient’s body (usually in a blood vessel)
• Catheter balloons (expands) too much
• Separating
• Failing during use
• Expansion or rupture
• Not operating as expected

Catheter Injuries can include:

• Ripping of tissue, organ, or other body parts
• Blood toxicity or poisoning
• Damage to the bladder or urethra (may transpire with urethral catheters)

Medical Malpractice or Product Liability Lawsuits?

Defective catheters typically lead to product liability lawsuits against manufacturers of defective devices. While some catheter complaints have resulted in medical malpractice lawsuits against the surgeons who implanted the catheter, such situations are very rare. Generally, evidence shows that the doctor followed the proper standard of care.  However, if a medical professional was negligent in implanting, withdrawing, or handling a patient’s catheter, such as failing to observe sanitation measures when extracting a catheter, they might be held liable for malpractice if injuries result from their actions.

CATHETER LAWSUITS

Patients filing port-catheter lawsuits allege that the manufacturing companies – mainly Bard Access Systems, Inc., and AngioDynamics – knew or reasonably should have known of the potential risks to users but chose not to issue a warning. However, after patients began filing complaints of complications, the medical device manufacturers issued warnings and voluntary product recalls. But many patients had already suffered serious and permanent health effects. Some deaths were reported.

Port-catheter lawsuits claim that some manufacturers used the 501(k) to market their product, which is a fast-track approval process based on a similar device already on the market, and port-catheters were not tested on humans prior to release. Other lawsuits claim that the companies ignored infection and sterility complaints for too long.

In most U.S. states a patient injured through the use of a defective catheter can bring a lawsuit based on the following legal theories:

• Design defects: These are inherent flaws in the design of the product itself. To prove a design defect, users typically demonstrate that there was a safer, feasible, and practical alternative design that the manufacturer could have used.
• Manufacturing defects: These occur when something goes wrong in the production process that makes the product unsafe. Establishing a manufacturing defect in a port catheter claim is rarer, and typically requires a showing that the product deviated from its intended design and that the deviation is what caused it to be unsafe.
• Failure to Warn defects: These involve inadequate instructions, failure to provide sufficient warnings about potential risks, or misleading marketing material provided to either consumers or the medical community. To prove a marketing defect, plaintiffs show that the manufacturer knew or should have known about a potential risk, that they failed to adequately disclose that risk, and that an injury resulted.

Bard PowerPort Lawsuits

The Bard PowerPort Implantable Port is also known as the “PowerPort”. The FDA has uncovered reports showing that over 10,000 patients have suffered injuries or side effects from the Bard catheters. Before 2019, Bard had filed 90% of these injury reports in a special Alternative Summary Reporting program, hidden from doctors and the public. Lawsuits include failure to warn.

Two Bard lawsuits filed in 2023 include a Chicago woman who had a PowerPort implanted in her neck for breast cancer chemotherapy. In just nine months she had to undergo several surgeries to remove the fragments from her heart and other areas. Her lawsuit was filed in the Northern District of Chicago and is part of the Bard PowerPort MDL.

Another breast cancer patient, a Kansas woman, received a Bard Power Port implant through her jugular vein for chemotherapy and years later she suffered complications, including included a hematoma, pain in her arm, and a high fever.

A growing number of lawsuits claiming a flaw in the chemical design and manufacturing of the Chronoflex catheters resulted in the PowerPort being weaker and less durable than it should have been. The PowerPort catheter is made from Chronoflex AL, which is a polyurethane material that is allegedly prone to fracturing, migrating, and otherwise malfunctioning after being implanted.

Chronoflex AL, sourced from a biomaterials supplier named AdvanSourceBiomaterials Corporation, also contains barium sulfate, which increases its visibility in radiologic studies. Over time, the barium sulfate particles dissociate from the catheter’s surface, resulting in microfractures and other structural alterations that compromise the mechanical properties of the catheter. Lawsuits further claim that the manufacturer used an excessively high concentration of barium sulfate particles in the production process, leading to issues such as improper mixing and the formation of barium sulfate and air pockets throughout the catheter body. These manufacturing defects resulted in an irregular catheter surface with fissures, pits, and cracks that can house harmful microbes or fungi, increasing the risk of infection and sepsis.

PowerPort lawsuits claim serious injuries related to the failure or malfunction of the Bard PowerPort implant including:

• Infection: Situations where individuals have developed infections or sepsis due to using the Bard PowerPort device, which can lead to severe health consequences and require extensive medical treatment.
• Catheter Fracture: Instances where the catheter of the Bard PowerPort device has broken or fractured, potentially causing severe health risks and complications. The PowerPort lawsuits alleged this is because the product was made so poorly.
• Deep Vein Thrombosis: Instances where the use of the Bard PowerPort device has led to the formation of blood clots or deep vein thrombosis (DVT), posing a significant risk to the individual’s health and potentially requiring additional medical interventions.
• Catheter Migration: Cases where the catheter of the device has moved from its intended position, leading to potential cardiac issues and other concerns requiring treatment.
• Vascular Damage:  Perforation of veins or other tissue by the PowerPort is also a concern. The fear is the device causes perforations or damage to blood vessels or surrounding tissues, resulting in complications and the need for further medical attention.

Failure to Warn

Bard began receiving adverse event reports (AERs) soon after the PowerPort was released. Attorneys have accused Bard of failure to warn as a result of these reports and that Bard was aware or should have been aware that the PowerPort had a substantially higher failure rate than other similar products on the market. Bard should also have been aware that the problems with the PowerPort were related to flaws in the Chronoflex material used to make the device. The PowerPort also had a higher failure rate than competitors, but rather than improving the PowerPort or issuing warnings, the Defendants pushed forward and aggressively marketed it as safe despite knowing its issues, according to court documents. Plaintiffs claim that Bard knowingly put a dangerous product on the market without adequately warning the users about potential risks.

CATHETER RECALLS

The FDA explanation of a medical device recall and a full list of recalled devices is here. Most patients don’t know if their catheter implanted during a procedure has been recalled, however a catheter injury lawyer can investigate and provide important information necessary to pursue a catheter injury lawsuit.

REASONS FOR CATHETER RECALLS

Offshore Manufacturing While many manufacturers have recalled various models of catheters, investigators have not definitively determined at what stage during manufacturer the defects occurred. One possibility is that manufacturing corners were cut to streamline costs, resulting in products less sturdy and more prone to failure during use. Investigators are looking at products manufactured offshore to determine whether inadequate testing and insufficient supervision resulted from attempts to increase production at lower costs.

The 510(k) Clearance - FDA A number of catheters have been approved by way of the 510(k) Clearance, an FDA loophole designed to allow medical products to come to market more quickly. This regulation allows an existing product to be updated without rigorous clinical testing if its design is similar to that of the device already on the market. Critics of the 510(k) Regulation say it gives manufacturers a pass on the need for rigid, expensive and time-consuming clinical trials that can often take years in order to conclusively determine the true safety and efficacy of a medical device as tested on volunteer subjects before the product (which bears fewer similarities and diminishing resemblance to the original product that was rigidly tested) is released to the wider market. This regulation can sometimes result in insufficiently tested materials and missed alterations brought to the market and may present serious risks to patients.

For instance, The Beacon Tip, the Shuttle Select and the Fetch 2 Aspiration catheters were all approved through the FDA’s 510(k) Clearance, and all three products recalled carry official FDA 510(k) numbers. They were all approved under an SESE classification, which is designated as ‘Substantially Equivalent.’ Catheters such as these ultimately were recalled by either the FDA and/or their manufacturers.

RECALLED CATHETER MANUFACTURERS

The amount of catheter recalls over the past few years is staggering. The recalls range from congenital heart treatment catheters to contrast material delivery catheters. The largest recalls involve catheters made by Cook Medical, Boston Scientific, Medtronic, and Vascular Solutions.

2023:

The FDA announced that Medtronic is recalling its Mahurkar Acute Dual Lumen High-Flow Hemodialysis Catheter, also known as the Mahurkar QPlus, due to a potential defect that can result in leaks. These catheters are used during hemodialysis, apheresis and infusion procedures. The recall covers 22,763 catheters distributed to customers from March 19, 2022, to Sept. 2, 2022. Two adverse events include insufficient flow in one patient and a blood clot in another.

Cardiovascular Business reported that Arrow International, a subsidiary of Teleflex, is recalling more than 250,000 Arrow Endurance Extended Dwell Peripheral Catheter System catheters after receiving reports of device separation and leakage. The FDA classified it as a Class 1 recall, meaning it “may cause serious injuries or death.” As of June there were been 83 complaints, including 18 reported injuries, but no deaths.

The FDA announced that Teleflex, and its subsidiary Arrow International, are recalling 1,905 pressure injectable central venous catheter kits due to mislabeling regarding the presence of chlorhexidine in these products.

2022:

Medtronic recalled its Mahurkar Acute Lumen High Flow Catheters for a catheter hub defect that could cause the catheter tubes to leak. That recall was also designated as a Class 1 recall by the FDA. Medtronic said that the tip of the catheter’s center lumen occluded after MDX, a silicone-based lubricant that is provided with the catheter, was excessively applied to the tip of the catheter. The FDA estimates that 210,200 catheters are included in the recall.

2020:

The FDA issued a Class 2 recall for three models of the Bard PowerPort, citing bloodstream infections, device displacement, catheter breakage, thrombosis and other serious issues. Bard voluntarily recalled PowerPort duo M.R.I. Implantable Port Kits for difficulty in flushing, infusion, and/or aspiration, and septum dislodgements during use.

Penumbra issued the voluntary recall for more than 30,000 Penumbra Jet 7 Reperfusion Catheter with Xtra Flex Technology, including the Jet 7 Max configuration which includes the catheter and Max delivery device. “Penumbra is recalling the JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death,” the company said in its Urgent Voluntary Medical Device Recall Notification. By January 2021 the FDA designated the recall a Class 1. By the end of December Penumbra had filed 239 reports of injury and 14 deaths.

Cook Medical recalled 37,326 Flexor Check-Flo introducers and Flexor tuohy-borst side-arm introducers. The FDA designated it a Class 1 recall. The Flexor catheters,  used to deliver medical devices to blood vessels, have an increased chance of separating at the proximal bond site and could cause serious adverse events, including longer procedure time, a separate procedure to take out a separated piece, blocking blood flow to vital organs, vessel injury and bleeding. According to an FDA warning, there have been 57 complaints and 14 reports of serious injuries.

Medtronic recalled 142 Rashkind balloon septostomy catheters after reports of the device breaking, separating or failing during use. Medtronic had two reported injuries and one death related to the device.

Teleflex’s Arrow International recalled 2,123 Arrow AutoCAT 2 and AC3 Optimus intra-aortic balloon pump (IABP) series in May and the FDA labeled the recall as Class 1 in July. The devices are cardiac assist devices used in patients that are undergoing cardiac and non-cardiac surgery. They are also used to treat patients with acute coronary syndrome or complications from heart failure. Balloons involved in the recall were distributed between March 15, 2018 and May 1, 2020.

The FDA announced the Class 1 recall of nearly 50,000 LeMaitre Over the Wire Embolectomy Catheters. These are used in the surgical removal of blood clots.

The FDA announced the Class 1 recall of about 6,000 Boston Scientific Imager II Angiographic Catheters. These are used to deliver contrast agents to blood vessels including carotid arteries so that doctors can better see inside them during imaging tests. The catheter tip could break off and lead to additional surgery to try to remove the tip, as well as to obstruction of blood flow (embolism), stroke, or death. The company knew of nine reported injuries related to this issue.

Nearly 14,000 Abbott Vascular NC Trek RX Coronary Dilatation Catheters and NC Traveler RX Coronary Dilatation Catheters, were recalled. The FDA announced the Class 1 recall of these devices that are used in cardiac (heart) procedures to open clogged blood vessels and improve blood flow to the heart. Abbott Vascular recalled the devices because the balloon catheters might not deflate as intended. The manufacturer traced the problem to weak material close to the balloon bond resulting from excessive exposure to heat during manufacturing.

2016

Over four million Cook Medical catheters were recalled after discovering the tip was susceptible to polymer degradation that allowed the tip to separate from the device while in use. The FDA reported more than 30 adverse events, explaining that the defect could cause a patient to suffer blocked vessels, require emergency intervention to retrieve pieces of the device from the body, or suffer vascular, genitourinary system, or soft tissue injuries. Patients could also suffer heart or lung embolism and organ damage.
 

DEFECTIVE CATHETER LEGAL HELP

Port catheter lawsuits are on the rise against certain manufacturers due to dangerous design defects associated with a number of different implantable port catheter devices.

Most people who undergo a surgical procedure do not know what type of medical devices their doctor used. If you have been injured due to a defective catheter, an experienced lawyer can determine:

• The manufacturer and brand name of the catheter used in your case
• The specific lot number
• The date it was used and how it was used in your treatment.

If your attorney determines that your catheter was recalled, that gives you an even better chance of a successful defective catheter lawsuit. If you or a loved one has suffered injuries, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Dec-11-24