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Catheter Class I Recalls May Fuel Product Liability Lawsuits

Jan 19, 2017

Lawyers Investigate Boston Scientific Fetch 2 Aspiration Catheter Lawsuits

Catheter Class I Recalls May Fuel Product Liability Lawsuits

The product liability attorneys at Parker Waichman LLP are investigating possible lawsuits on behalf of clients who suffered an injury, allegedly due to a defective or recalled catheter. The firm, which has decades of experience representing clients in medical device litigation, continues to offer free legal consultations to individuals with questions about filing a catheter lawsuit.

Several Class I recalls have been issued for catheters, which are flexible tubes inserted into the body to allow the flow of fluid. A urinary catheter, for example, allows the flow of urine from the bladder. Catheters are also used to administer medications. Several models and brands of catheters have been subject to Class I recalls, the most serious type of recall issued by the U.S. Food and Drug Administration (FDA). A Class I recall indicates a situation where exposure to a recalled device leads to serious injury or death.

Catheters are undoubtedly useful in medicine. Catheter lawsuits are filed when products are manufactured or designed defectively, placing patients at risk for injury or death. Some cases allege that device makers did not test their products adequately before selling them. A concern with some recalled catheters, for instance, is that they can break off in the patient's body.

A Class I recall was issued for Boston Scientific's Fetch 2 Aspiration Catheter due to shaft breakage. After receiving complaints, the company recalled all models of the Fetch 2 Aspiration Catheter in March 2016. The product, also referred to as a thrombectomy catheter, is used to remove small blood clots from coronary arteries during surgery.

"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 FDA states in an April 2016 recall notification. "If breakage occurs while the device is in a patient, pieces of the catheter may block blood supply to the heart or blood vessels. This could result in the need for additional medical procedures, patient injury, or death."

The recall affects some 21,155 units manufactured between Jun. 11, 2014 and Feb. 19, 2016.

Centurion Catheter, Vascular Solutions Cather

Centurion Catheter, Vascular Solutions Cather

Recalled Due to Excess Material in Catheter Tip Another recall was recently issued for Centurion Convenience Kits containing Multi-Med Single Lumen Catheters. According to a Dec. 9, 2016 recall, the Class I recall was issued because the catheter tip may contain excess materials, which can lead to serious complications and death if the materials enter the patient's blood stream. The issue reportedly stems from a manufacturing defect.

The recalled Centurion catheter is used to administer drugs or fluid, or draw blood from patients. Customers first learned of the recall in an Oct. 21, 2016 Urgent Recall Notice. The recall affects approximately 1,000 kits in the United States distributed between May 23, 2016 and Oct. 18, 2016.

"The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process." the FDA notification states. "If this occurs, the excess material may separate from the catheter during use and could enter the patient's bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death."

Similar to the Centurion recall, Vascular Solutions recalled its Twin-Pass Dual Access catheters due to excess material in the catheter tip. The company said the excess material was a result of the manufacturing process. The recall was also designated as Class I by the FDA. All unexpired lots of the catheter were recalled nationwide on Sept. 16, 2016. Using the recalled catheters can cause blood clots and death.

"All unexpired lots of the product have been recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen," Vascular Solutions said in an Oct. 4, 2016, press release. "It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death. No injuries have been reported in association with this issue to date."

The recall affects unexpired lots of Model Numbers 5200, 5210 and 5230 manufactured between October 2014 and August 2016 and distributed from October 2014 to September 2016. The release states that 15,986 catheters have been manufactured; 5,784 have been distributed in the United States, and 9.2 percent of the devices may have the condition triggering the recall.

Recall Issued for Medtronic Catheter

Due to an embolism risk, Medtronic recalled four neurovascular products: Medtronic's Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire as well as the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters, according to Wall Street Journal.

Medtronic recalled the catheter products because the coating can separate and cause blood clots when it enters the blood stream. "This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event," Medtronic said in a press release.

Parker Waichman is investigating potential lawsuits on behalf of consumers who suffered injuries related to the use of a recalled catheter. The firm continues to offer free legal consultations.

Filing a Personal Injury, Product Liability Lawsuit

Parker Waichman is a national personal injury law firm that represents clients in drug and medical device lawsuits. Our goal is to ensure patient safety and hold manufacturers liable in situations where they failed to warn patients and physicians about the risks associated with a drug or medical device. Misrepresenting the safety of a medical product puts patients at risk. If you or someone you know suffered a drug or medical device injury and want to learn more about filing a personal injury lawsuit, contact our firm today by filling out our online form or calling 1-800-YOURLAWYER (1-800-968-7529).


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