FDA Labels Abbott Catheter Recall as Class I
Due to the risk of life-threatening injury and death, Abbott urged its customers to stop using some of its coronary catheters. The recall affects the Abbott NC Trek RX Coronary Dilatation Catheter, Abbott NC Traveler Coronary Dilatation Catheter, and Abbott NC Tenku RX PTCA Balloon Catheter. Abbott has received reports of problems removing the balloon sheath, potentially leading to fatal complications. The U.S. Food and Drug Administration (FDA) labeled the recall as Class I.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device injury litigation. The firm, which keeps up-to-date with medical device recall news, continues to offer free legal consultations to individuals with questions about filing a lawsuit.
Class I recalls are reserved for situations where exposure to the recalled device presents a reasonable risk of serious injury or death.
The recall affects devices manufactured between Jan. 1, 2015 and Jan. 2, 2017 and distributed between Jan. 1, 2015 and Mar. 14, 2017. A total of 132,040 catheters are being recalled in the United States, according to a recall alert posted on the FDA website.
The products are coronary dilation catheters used in several cardiac procedures. They help improve blood flow to the heart by dilating a stenosed artery, dilating a blocked or clogged artery in patients who have had a heart attack, and dilating a stent after implantation.
The catheters are being recalled because doctors report difficulty removing the balloon sheath, which “can result in issues with inflating or deflating the balloon during procedures and may cause serious adverse health consequences including: air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and death.”
Abbott warned of potentially fatal injuries if “excessive force” is used to remove the sheath. The company issued a field safety notice on March 22. Customers were instructed to “immediately stop using the devices,” check to see if they have any affected devices in stock, and return any unused recalled catheters.
Abbott received 19 reports of injury and one report of death associated with this issue.
Catheter Recalls and Product Liability Lawsuits
Parker Waichman notes that many other catheter products have been recalled recently. In general, catheters are used to allow flow of fluid in the body.
Recently, ReFlow Medical recalled its Wingman 35 Crossing Catheters because the tip can split or separate, leading to potentially fatal complications. The separated tip could, for instance, interfere with blood flow to organs. The FDA labeled the recall as Class I.
Another Class I recall was issued for Bard Peripheral Vascular’s Halo One Thin-Walled Guiding Sheaths because the device may separate during use. If this happens, the device can tear blood vessels, leading to excessive bleeding and death.
The device is a guiding catheter that introduces devices through an incision in the patient’s leg.
“The use of affected sheaths may result in prolonged procedure times and on additional surgical intervention to remove detached components from the patient,” the notification states. “The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.”
Several catheter products were recalled in 2016, including the Centurion Convenience Kits containing Multi-Med Single Lumen Catheters. According to a December recall notification, the device was recalled due to a manufacturing defect that caused excess material to be present in the catheter tip. Patients may experience life-threatening complications if the material enters the patient’s blood stream.
“The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process,” the FDA recall 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.” Regulators labeled the recall as Class I.
A similar Class I recall was issued for Vascular Solutions Twin-Pass Dual Access catheters. The device was associated with problems attributed to excess material in the catheter tip due to a manufacturing defect.
“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 catheters were manufactured between October 2014 and August 2016. They were distributed between October 2014 and September 2016. Vascular Solutions has manufactured a total of 15,986 units. In the United States, 5,784 catheters have been distributed. The device maker says 9.2 percent of the catheters may be affected by this issue.
In March 2016, a Class I recall was issued for Boston Scientific’s Fetch 2 Aspiration Catheter due to a risk of shaft breakage. The device, also called a thrombectomy catheter, is used to remove small blood clots from coronary arteries during surgery.
According to the alert, 21,155 units are affected; they were manufactured between Jun. 11, 2014 and Feb. 19, 2016.
“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.”
Filing a Catheter Injury Lawsuit
If you or someone you know suffered an injury related to a defective or recalled catheter and want to learn more about filing a medical device injury lawsuit, contact an experienced personal injury attorney at Parker Waichman today. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).