Attorneys Investigating Possible Catheter Lawsuits, Class I Recalls
The personal injury attorneys at Parker Waichman LLP are investigating possible lawsuits involving allegedly defective catheters. 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 catheter products have been recalled due to safety concerns.
A catheter is a flexible tube inserted into the body to allow the flow of fluid; for example, a urinary catheter collects urine from the bladder. Various catheters have been recalled recently. According to an Apr. 19, 2016 recall alert posted on the U.S. Food and Drug Administration (FDA) website for example, Boston Scientific recalled its Fetch 2 Aspiration Catheter due to shaft breakage. The recall was designated as Class I by the FDA.
Class I recalls are the most serious type of recall; they are reserved for situations where exposure to the recalled device presents a reasonable risk of serious injury or death.
According to the recall alert, Boston Scientific voluntarily recalled all models of its Fetch 2 Aspiration Catheter on Mar. 22, 2016 after receiving reports of shaft breakage. The recalled device is known as a thrombectomy catheter; it is used to remove small blood clots from coronary arteries during surgical procedures. The cases of shaft breakage occurred during the procedure. The broken fragment was reportedly removed while still partially attached to the rest of the device or retrieved with another device. Patients did not suffer any additional complications thus far, the alert states. The Fetch 2 catheter product is packaged and labeled as a Bayer product, because Boston Scientific acquired the catheter from Bayer Medical Care Inc.
“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 recall notice states. “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 recalled catheter was manufactured between Jun. 11, 2014 and Feb. 19, 2016. Some 21,155 devices are affected by the recall, the alert states.
Class I Recall Issued Over Centurion Catheter
Parker Waichman notes that other Class I recalls have recently been issued over catheter products. According to a Dec. 9, 2016 recall alert posted on the FDA website, a Class I recall was issued for Centurion Convenience Kits containing Multi-Med Single Lumen Catheters. The recall was issued because there may be excess materials at the tip of the catheter due to the manufacturing process. This could lead to serious complications, including death, if the excess material enters the patient’s bloodstream.
“The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process.” the recall alert 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.”
The recalled catheter is used to draw blood, or administer drugs or fluid. Centurion notified customers of the issue in an Oct. 21, 2016 Urgent Recall Notice. The catheters were distributed between May 23, 2016 and Oct. 18, 2016. Roughly 1,000 kits are affected in the United States.
Vascular Solutions Twin-Pass Dual Access Catheter Recall, Medtronic Recall
The FDA also placed its most serious Class I label on a recall of Vascular Solutions Twin-Pass Dual Access catheters. According to an Oct. 4 press release, Vascular recalled all unexpired lots of the catheter nationwide on Sept. 16. The catheters have the same issue at the Centurion recall; excess material may remain at the tip of the catheter due to the manufacturing process, posing a risk of 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.” the release states. “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 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. The recalled catheters were manufactured from October 2014 to August 2016. They were distributed from October 2014 to September 2016. Unexpired lots of Model Numbers 5200, 5210 and 5230 were affected.
An embolism risk triggered another recall of catheter products. In October, Medtronic voluntarily recalled four neurovascular products: Metronic’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. The recall was issued because the coating on the devices can separate and enter the blood stream, causing a blood clots.
“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.
Filing a Personal Injury 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).