Defective Catheter Recalls and Catheter Lawsuits
Many medical device manufacturers and the FDA have initiated multiple catheter recalls after receiving reports of serious health complications potentially linked to catheter device failure. Subsequently, lawyers have been investigating complaints and defective catheter lawsuits have been filed. Among the issues cited in the recalls were catheter separation and breakage causing fractures that can migrate through a patient’s body, leading to perforation of blood vessels; embolization of fragments throughout the vascular system, including the lungs and heart; and may cause death or serious injury.
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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.
According to the Journal of Medical Engineering & Technology , the problem with defective catheters is that they are prone to degrade and fracture. If a catheter fractures, parts of the catheter when broken loose can float freely in the bloodstream and travel to the heart, lungs, or other vital organs, causing serious injury and even death.
Catheter Recalls and the FDA
The FDA lists its recalled devices and explains “What Is a Medical Device Recall?”
Why So Many 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: topping the biggest medical device recall in 2016 (according to medtechchina) was Cook Medical's Single Lumen Central Venous Catheter Sets and Trays; Single Lumen Pressure Monitoring Sets and Trays; Femoral Artery Pressure Monitoring Catheter Sets and Trays; Radial Artery Pressure Monitoring Catheter Sets and Trays. In October 2015, Vascular Solutions recalled more than 15,000 catheters.
Cook Medical Catheter Recall In April 2016, Cook Medical recalled more than four million catheters that used Beacon Tip technology. These catheters are used to place contrast dye into blood vessels in the heart in preparation for cardiac angiograms. According to Cook Medical, those catheters can experience polymer degradation of the tip, which can result in the tip fracturing and/or separating. As of the time of the recall, Cook Medical was aware of 30 medical device reports concerning tip fracture or separation. The Shuttle Select Slip Catheter, also manufactured by Cook Medical, was recalled in April 2016.
Boston Scientific Catheter Recall In March 2016, Boston Scientific recalled its Fetch 2 Aspiration Catheter due to reports the catheter shaft could break and embolize during surgical procedure (to remove small blood clots from coronary arteries) at various points along the device, leading to obstruction of blood flow and the need of additional surgery to remove the device and its fragments. As well, its iCross and Atlantis SR Pro 2 Coronary Imaging Catheters were recalled.
Medtronic Catheter Recall Medtronic recalled its Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, due to the possibility that the ventricular catheter may become detached from the snap base assembly after implantation and may require emergency corrective surgery. The ventricular catheters are part of a surgically implanted system that redirects excess fluid from the brain to another part of the body. The recalled product was distributed from April 29, 2004 through December 12, 2008. Medtronic sent their customers a recall notice on February 13, 2009.
In October 2016, Medtronic recalled certain lots of its Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow - flow directed micro catheters and Marathon flow directed micro catheters. The concern here is over the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices, releasing particulate into the bloodstream. Depending on the size and quantity of the particulate, the latter could lead to a thromboembolic event.
The FDA issued a Class 2 recall in 2008 to the Medtronic Neuromodulation INDURA IP, consisting of 2 models of intrathecal catheter, the sutureless pump, and the intrathecal catheter pump segment revision kit. The agency said that Medtronic knew about deficiencies at a manufacturing facility in Puerto Rico nearly two years before triggering the recall.
In 2012 Medtronic issued a safety communication to its customers over the potentiality for double the rate of device failure should unapproved drugs be used in concert with their SynchroMed pumps.
Stryker Sustainability Solutions Catheter Recall In June 2016, Stryker Sustainability Solutions initiated a recall of Angiodynamics Soft Vu Omni Flush Angiographic Catheters, due to reports of separation of the tip, which could cause loss of device function and serious medical complications. "Tip separation can also lead to internal organ injury and cause stroke, kidney failure and intestinal failure among other serious adverse health consequences, including death," the company noted. As with the Cook Medical recall, the Stryker Sustainability Solutions recall was classified by the FDA as a Class 1 recall, the most serious type of recall.
Vascular Solutions Catheter Recall In March 2015, Vascular Solutions’ recalled two U.S. models of its Guardian II hemostasis valves because of a potential defect with an internal seal that could allow air to leak into the device and enter the body, creating the risk of an air embolism.
In October 2016 Vascular Solutions recalled its Twin-Pass Dual Access Catheters due to excess material at the tip of the catheter left over from the manufacturing process. A total of 15,896 devices were manufactured and distributed globally between October, 2014 through September of this year, with about a third distributed in the US.
TFX and Vascular Solutions recalled in June 2017 over 4,600 Venture Catheters because the tip can break off in a patient’s blood vessel and cause an embolism, blood clots, organ damage, or death.
In July 2017 it recalled Langston V2 Dual Lumen Pressure Monitoring Catheters that were manufactured between January and April and sold until May. The catheter is used to deliver dye (contrast medium) into a patient’s blood vessels during medical imaging tests (angiographic studies) that allow clinicians to see internal body structures. The device also measures pressure within the blood vessel. The problem is that the inner catheter can separate from the device hub during use and should this occur, patients will require an intervention procedure to retrieve the broken device from their bloodstream. If it travels in the bloodstream, it could cause life-threatening adverse health consequences, including death.
Other Recalled Catheter Manufacturers
Acclarent Inspira AIR Balloon Dilation System Recall The Acclarent Inspira AIR Balloon Dilation System was recalled because it has the potential not to deflate, or to deflate slowly. The Inspira AIR Balloon Dilation System is an airway balloon catheter intended to dilate and restore airflow to a patient' airways. Acclarent received four reports where difficulty deflating the balloon occurred after the surgeon pulled against resistance in response to the balloon moving during dilation. The force applied to the catheter stretched and narrowed the catheter shaft, causing the balloon to be difficult or impossible to deflate.
AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty (PTCA) Recall The AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters were recalled because they may become separated during use, and fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death. This product was distributed from January 30, 2009 through December 4, 2009. The AngioSculpt PTCA Scoring Balloon Catheter is used to dilate narrowed coronary arteries and to improve blood flow to the heart muscle.
Centurion Catheter Recall In October 2016, Centurion issued an urgent recall of its Centurion Convenience Kits containing Multi-Med Single Lumen Catheters distributed between May 23, and October 18 of this year. The catheters are inserted into a blood vessel for the sampling of blood – a standard medical procedure. The problem is the observance of excess material that remains at the tip of the catheter during the manufacturing process. The excess material could break away from the catheter while in the blood vessel and cause serious health implications including, but not limited to the development of blood clots, embolism or the migration of excess material to vital organs. About 1,000 kits are affected.
Johnson & Johnson’s Cordis Corporation Subsidiary Catheter Recalls J&J issued two recalls for Fire Star RX and Dura Star RX coronary balloon catheters, which are inserted into the heart to open up blood vessels. They were recalled in January 2008 because they pose a risk of “slow deflation or no deflation,” which could block the blood vessel and cause serious injury or death, according to the FDA.
OriGen Biomedical OriGen recalled two lots of VV28F Reinforced Dual Lumen ECMO Catheters N18487 and N18487-1 following reports of adverse events associated with the devices. The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less (USA) or less than 29 days (rest of world).
Penumbra Neuron 5F Select Catheter Recall Penumbra recalled the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009.
Spectranetics Catheter Recall Specatranetics recalled its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in some device units. Spectranetics’ Bridge Occlusion Balloon Catheter is a device intended to temporarily block the superior vena cava (SVC) when emergency control of hemorrhage is required. The Bridge Occlusion Balloon catheter is constructed of a compliant balloon mounted on a dual lumen shaft. The guidewire lumen is used to pass the catheter over a guide wire. According to the FDA recall notice, if a device with a blocked guidewire lumen were to be used during the procedure, the device would not be positioned correctly and hemorrhage would not be controlled. This would delay life-saving treatment, which may result in immediate and serious adverse health consequences, including death.
Teleflex Medical Arrow Arterial Embolectomy Catheter Recall Teleflex Incorporated recalled all lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010. Testing revealed pin holes in some of the pouches in which the products are packaged, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death.
Thomas Medical Coronary Sinus Guide Systems Thomas Medical Products Inc. recalled certain lots of its product, which are tube-like devices placed into blood vessels to insert pacing or defibrillator wires and catheters into blood vessels. The sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries. From there, the broken tip could cause a blockage anywhere, including the brain or heart, leading to permanent injury, such as a stroke or heart attack, or even death.
In 2015, Herman Helmer Jr from Louisiana filed a catheter injury lawsuit against Covidien and Medtronic. A broken piece of a catheter was left inside his brain when it got stuck in an artery during a procedure to remove blood clots and improve circulation. Case No. 2:15-cv-04835.
In 2016 a Texas woman, Debra Wilson, died at the age of 60 when an 8-inch fragment of a catheter was left in her heart in 2007. Her husband Charlie filed a wrongful death lawsuit against the hospital for failing to remove it for seven years. A catheter lawsuit against the hospital alleged medical malpractice. Hospital records show the large tube fragment was visible on X-rays conducted as early as November, 2007 but the Wilsons allege they were never told until Debra suffered a debilitating heart attack in August of this year. The Dallas Morning News report indicated surgery to remove the fragment was deemed too risky. The catheter lawsuit was eventually dismissed, however Charlie says he will either appeal, or refile his catheter lawsuit founded upon different claims now that his wife is dead.
How Defective Catheter Attorneys Can Help You
- 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.
Defective Catheter Legal HelpIf you or a loved one has suffered similar damages or 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.
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The Recalled Fetch 2 Aspiration Catheter Received FDA 510(k) Clearance
Washington, DC: When the Fetch 2 Aspiration Catheter was originally launched by Bayer Medical Care Inc., (Bayer), there was no shortage of platitudes which, sometime later presented as a stark contrast to the eventual global recall that resulted in many a lawsuit amidst allegations of defective catheters causing injury.
“Why Use Fetch 2 Aspiration [Catheter]?” was a question posed by the online brochure posted by Bayer when the device was released. “You choose a manual aspiration device for its ease of use and its ability to quickly resolve small, fresh thrombus, in coronary arteries. The Fetch 2 Aspiration Catheter offers enhanced handling and kink resistance thanks to a variable pitch coiled proximal shaft. You want to reach into small vessels and cross tight lesions. The Fetch 2 Aspiration Catheter can get you there with a low 4.2 French catheter profile and convex-cut opening to reduce risk of vessel wall damage.
“Finally, you want your aspiration device to effectively restore flow. The Fetch 2 Catheter has demonstrated effective clot removing ability, despite its low profile.”
Those lofty platitudes soon evaporated, however when the Fetch 2 Aspiration Catheter was recalled in March of last year over complaints related to breakage associated with the device shaft.
The recall, initiated by medical device manufacturer Boston Scientific Corporation (Boston Scientific) after acquiring the Fetch 2 catheter product line from Bayer, was a voluntary recall nonetheless
“Boston Scientific Corporation is recalling the Fetch 2 Aspiration Catheter because the catheter shaft may break at various points along the device, before or during procedures,” the
A Class 1 recall, under which the Fetch 2 fell, is considered the most serious recall available to be issued by the FDA. “Use of these devices may cause serious injury or death,” the regulator said in its recall notice.
The catheters were recalled simultaneously in the US and in Canada on March 22 of last year. Less than a month later Boston Scientific issued a press release dated April 8, 2016 formally announcing the recall.
The recall was officially terminated about 16 months later, August 11 of this year. The official posting on the FDA website indicates the Fetch 2 Aspiration Catheter was among the scores of problematic medical devices initially approved through an FDA 510(k) Clearance [#K101354]. Approved under a substantially equivalent (SESE) designation, the decision reflects no third party review.
Why so many Catheters Recalled?
Santa Cruz, CA: Another catheter was recalled last week, and this one got a Class 1 recall category, meaning the most serious kind.
The FDA recalled a bridge occlusion balloon catheter “due to the possibility of blocked guidewire lumen in select device units”. The Bridge Occlusion Balloon Catheter, made by Spectranetics, is designed to temporarily block the superior vena cava in the event of hemorrhage, according to the alert. The company sent a notice directing physicians to confirm that the guidewire lumen is open and unblocked prior to start of the procedure and to have backup units on hand, and the FDA stated that Spectranetics recommends health care professionals and patients report any adverse events or side effects related to the use of the product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
But what are the chances of a patient reporting an adverse event, given that the balloon catheter has been slapped with a Class 1 recall? The
Why are so many catheters recalled?
To start with, catheters are flexible tubes inserted through narrow openings into body cavity. The recalled catheters are not urinary catheters; those recalled are used for medical procedures, such as injecting dye for angiograms, or removing small blood clots from veins and arteries. According to the Journal of Medical Engineering & Technology the problem with the affected catheters is that they are prone to degrade and fracture. Tips and other components have broken or separated, resulting in serious patient injuries, and even in patient death. Once these fractures have broken loose, they can potentially float freely in the bloodstream and travel to the heart, lungs, or other vital organs. Hence a Class I recall.
But liability has yet to be definitively determined: At what point during manufacture have the catheter defects occurred? One law firm, Chandler Mathis Zivley, says that, “Investigators are now looking into the possibility that corners have been cut in attempts to streamline costs, resulting in products that are less sturdy and more prone to fail during use. One aspect of the investigation is focused on whether having products manufactured offshore, in an attempt to improve efficiency and lower costs, has resulted in inadequate testing and insufficient supervision that may underlie the problems.” Stay tuned…
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