Medical Catheter Lawsuits Filed in Response to Problems and Recalls

On January 29, 2021, the U.S. Food and Drug Administration (FDA) alerted healthcare providers and patients to issues with Penumbra JET 7 Xtra Flex Catheters. These are medical devices used to treat patients suffering from a stroke.

At the time of the announcement, the FDA had received over 200 medical device reports (MDRs) of problems concerning the JET 7 catheters, including deaths, serious injuries, and malfunctioning. Penumbra issued an urgent recall of all Jet 7 Xtra Flex catheters based on the risk of injury or unexpected death.

This is one of many recent recalls of medical catheters. Those injured by these devices may be eligible to file catheter lawsuits to recover damages.

What is a Catheter?

A catheter is a thin, flexible tube inserted through a narrow opening into the body. Most people have heard of urinary catheters, which are used to empty the bladder and collect urine in a drainage bag. But there are other types of catheters used in a variety of medical procedures.

Catheters are made from medical-grade materials, come in a variety of sizes, and serve a broad range of functions.

• Drainage of fluids: A urinary catheter drains urine from the body, whereas a different type of catheter may drain fluid from an abscess.
• Administering of fluids: Some catheters allow doctors to administer intravenous fluids or medications.
• Administration of medications: Doctors may use catheters to administer medication, such as providing anesthetic medication into the epidural space during childbirth.
• Breathing tubes: Some catheters are used as breathing tubes and administer oxygen and other breathing gases.
• Subcutaneous: These types of catheters are placed under the surface layer of the skin and there administer medications like insulin. These are commonly used in insulin pumps.
• Cardiac treatments: When blood vessels are narrowed or blocked, doctors may treat them with medical devices that include catheters.

Doctors also use catheters in minimally invasive procedures where they make a small incision and then thread a catheter to the affected area. They may then push medical instruments or treatments through the catheter to treat the problem.

What Are the Problems with Catheters?

Several catheters have been recalled over the past year because of problems like the following:

• 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

In the case of the Penumbra JET 7 Xtra Flex catheter, several problems were reported, including ballooning, expansion, rupture, breakage or complete separation, and exposure of the internal support coils near the distal tip region.

Penumbra JET 7 Xtra Flex Catheter Recall

The Penumbra JET 7 Xtra Flex is a catheter used with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing to remove clots and restore blood flow in patients experiencing an acute ischemic stroke.

During a thrombectomy procedure (the removal of a blood clot in an artery leading to the brain), the doctor inserts the catheter through a small incision in the groin or wrist. The catheter is then guided to the arterial blood clot, after which the doctor uses suction to remove the clot, restoring blood flow to the patient’s brain.

This sort of treatment can be life-saving in the case of a stroke. If something goes wrong with the catheter, however, the treatment can cause additional injury or even death.

In December 2020, Penumbra initiated a voluntary recall of all configurations of the JET 7 Xtra Flex catheter from the market. In the company’s urgent voluntary medical device recall notification, it stated that it was recalling the product because “the catheter may become susceptible to distal tip damage during use.” (A distal tip is the tip of the tube that is the furthest away from the user—in this case, from the doctor or surgeon.)

Should this occur while the product was in use, it could result in potential blood vessel damage and subsequent patient injury or death.

What Can Go Wrong with the Penumbra JET 7 Xtra Flex Catheter?

In the medical reports sent to the FDA concerning problems with the Penumbra JET 7 Xtra Flex, doctors alleged that the tip of the catheter (the distal tip) would suddenly expand or break while still inside the patient’s artery.

The severe expansion of a balloon catheter can rupture an artery, causing bleeding in the brain that can result in death. Should the tip break off, it may remain in the artery, which can cause serious injuries and typically requires additional surgery to remove the tip. These procedures, in turn, can create additional risks to the patient’s health.

Out of the 200 MDRs the FDA received associated with the Penumbra JET 7 Xtra Flex, twenty described 14 unique patient deaths. (There were different reporting sources for some of the single events.) Other reports described serious patient injuries such as blood vessel damage, hemorrhage, and cerebral infarction (stroke).

Penumbra advised customers to remove all units from their inventory and return them to the company.

Other Catheters Recalled in the Last Year

Several other catheters were recalled in 2020 for problems similar to those seen with the Penumbra JET 7 Xtra Flex. Below is a brief overview of these. A Class I recall is the most serious type of recall and indicates the product may cause serious injuries or death.

Abbott Vascular NC Trek RX Coronary Dilatation Catheters

On February 19, 2020, the FDA announced the Class I recall of nearly 14,000 Abbott Vascular NC Trek RX Coronary Dilatation Catheters and NC Traveler RX Coronary Dilatation Catheters. These devices 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.

Use of the devices could result in reduced blood flow to the heart, air embolism, blood clot in the artery, heart attack, and additional surgery. The company had received 13 complaints related to the issue, including one death.

LeMaitre Vascular Over the Wire Embolectomy Catheter

On April 2, 2020, the FDA announced the Class I recall of nearly 50,000 LeMaitre Over the Wire Embolectomy Catheters. These are used in the surgical removal of blood clots.

Like the previous recall, this one was also implemented because the balloon catheter could fail to deflate during use. Should this occur, the tip of the catheter could separate and block the patient’s blood vessel while the surgeon tried to remove the inflated balloon catheter. This could cause serious injury while requiring additional procedures to remove the tip or balloon pieces.

The FDA received 26 MDRs concerning this issue, with no deaths and one injury.

Boston Scientific Imager II Angiographic Catheters

On April 7, 2020, the FDA announced the Class I 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.

There was a potential for the catheter tip to break off during a patient procedure or preparation for that procedure. That could lead to additional surgery to try to remove the tip, as well as to obstruction of blood flow (embolism), stroke, or death. The company was aware of nine reported injuries related to this issue.

Vascular Solutions Langston Dual Lumen Catheter

On April 30, 2020, the FDA announced the Class I recall of about 4,000 Vascular Solutions Langston Dual Lumen Catheters. Like the previously listed products, these are used for the rapid delivery of dye (contrast material) into a patient’s blood vessels during medical imaging tests so that clinicians can better view body structures.

The catheter tip could break off during use, potentially causing blood clots or blood vessel damage. Should this occur, the dye could spray the doctor as well, potentially leading to an infection. The company was aware of eight complaints and no reports of injury or death.

Applied Medical Python Catheters

On May 12, 2020, the FDA announced the Class I recall of about 19,000 Applied Medical Python Catheters. These included:

• Python Embolectomy Catheters
• Bard Embolectomy Catheters
• OTW Latis Cleaning Catheters

These are latex balloon catheters used for the temporary blockage, closing of a blood vessel, or infusion of fluids. These devices were vulnerable to the same problem of the tip detaching during use. Should this occur, pieces of the catheter could break off into the patient’s body, potentially causing serious injuries or death.

The company was aware of 46 complaints regarding the issue between 2015 and the time of the recall. The FDA received three MDRs and no reports of death or injury.

Medtronic Rashkind Balloon Septostomy Catheters

On November 3, 2020, the FDA announced the Class I recall of about 140 Rashkind Balloon Septostomy Catheters. These are used to treat patients with cyanotic congenital heart defects, which affect blood flow and can result in low blood oxygen levels.

Quality issues could lead to the device breaking, separating, or failing during use. This could cause blood vessel damage and death. The company was aware of two reported injuries and one death related to this issue.

In addition to this recall, Medtronic also stopped manufacturing and distributing these catheters due to reasons unrelated to this recall.

Catheter Recall Information Helpful in a Personal Injury Lawsuit

Unfortunately, most patients don’t know what devices their doctors use during procedures like these that are associated with catheters. A catheter injury lawyer can perform an investigation to unearth this information, which can help provide important information in a catheter injury lawsuit.

If your attorney discovers that your catheter was part of a recall, that gives you an even better chance of winning your personal injury lawsuit. Contact the personal injury attorneys at Chaffin Luhana for a free initial consultation today.