The benefits and usefulness of catheters are not in question, when the broad scope of applications and indications for which the devices are used are examined. Catheters are used for administering medications, injecting contrast dye for angiogram procedures, and removing small blood clots (thrombectomy) from arteries and veins.
However, there are risk factors suggesting defective catheters are causing serious injuries prompting approximately four million allegedly defective devices to be recalled from the market. Given the number of reasonably common medical procedures for which catheters are routinely used, it is fair to assume catheter injury lawsuits will emerge.
The degradation of catheters and catheter parts appears to be the initial problem. This breakdown of materials may lead to the fracture of catheter tips and fracture and separation of the catheter components. When material, or pieces of the catheter break away from the device and float freely in the bloodstream, serious injury or death may occur for some patients. If this free-floating material migrates to the lungs, heart, or other vital organs, the outcome may be deadly.
Cook Medical, Boston Scientific, and Centurion are a few of the manufacturers that have recalled many catheters of various models. Medtronic and Vascular Solutions are two additional manufacturers that have initiated recalls.
Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in lawsuits regarding allegedly defective medical devices, including catheters.
Potential Causes of Catheter Issues
Questions surround the catheter recalls concerning where the problems originate. Since the medical field, that includes medical devices, is always evolving with new technologies and new and improved products, does the interest in profits for the shareholders, trump concern for the consumers’ safety?
Manufacturers in the interest of efficiency and to streamline costs, have employed various methods for achieving those ends. For example, manufacturers may have their products made off-shore, with materials that are at times, allegedly not adequately tested over long-term use.
The U.S. Food and Drug Administration (FDA) has a 510(k) approval process which is a method to bring new products to market faster. This accelerated procedure functions by enabling manufacturers to forego the requirement for rigorous testing if they are able to prove that the new device is “substantially equivalent” to an older product that is already FDA approved.
The result of this fast-track process means that the stringent clinical testing and trials that the original device had to undergo, is foregone by the newer product.
Medical devices, including catheters, which leave fragments behind in the human body, bring a plethora of potential complications and problems for the patient. The locating and removal of potentially small fragments can lead to overwhelming harm to a patient.
Boston Scientific Catheter Recall
Boston Scientific has recalled all models of the Fetch 2 Aspiration Catheter in the spring of 2016. The FDA classified this as a Class 1 category recall, which is the most serious type of recall. This category is reserved for this kind of recall where the FDA deems a reasonable probability to exist that “use or exposure to the violative product will cause serious adverse health consequences, or death.”
The Fetch 2 Aspiration Catheter works by clearing blood clots from coronary arteries by the procedure known as thrombectomy. The long, flexible device pushes through the arteries and vacuums clots from blood vessels. This allows blood to flow more freely by removing any obstructions, reports Drugwatch.
The reason given for the recall is the catheter shaft may break prior to or during the procedure, at various points along the device. Should the breakage occur while the device is in a patient, bits of the catheter may block blood supply to the heart or blood vessels, and would need to be surgically removed.
In September 2014, Boston Scientific acquired the company from Bayer Medical Inc., so all inventory that was recalled still had the Bayer label. Manufacturing dates for the recall were June 1, 2014 to February 19, 2016, according to the FDA website.
Boston Scientific released a statement that said, “All reports of shaft breakage happened during the procedure and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications,” Drugwatch reports.
In addition to the Fetch 2 Aspiration Catheter, the Shuttle Select Slip-Catheter, and the Beacon catheter, are some of the other devices that have been recalled.
Filing a Catheter Lawsuit
If you or someone you know suffered injuries associated to the use of a catheter, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please contact Parker Waichman medical device attorneys at 1-800-YOURLAWYER (1-800-968-7529).