Abbott Vascular Recalls Three Coronary Catheters Over Balloon Sheath Removal
Device maker, Abbott Vascular, just advised hospitals and healthcare professionals to immediately stop using some of its coronary catheters due to issues with removing the balloon sheath. This defect may lead to injury or death, According to FierceBiotech.com. The U.S. Food and Drug Administration (FDA) deemed the action a Class I recall, the agency’s most serious recall designation. According to the agency use of a recalled device deemed a Class I, may result in serious injury or death.
Abbott Vascular issued a field safety notice on March 22, 2017 concerning three of its catheters, the NC Trek RX and NC Traveler RX coronary dilatation catheters, as well as the NC Tenku RX PTCA balloon catheter. The devices are used to dilate a coronary artery following stent implantation and to improve or restore blood flow in coronary arteries by use of balloon dilation.
This recall involves devices manufactured between January 1, 2015, and January 2, 2017, and might affect as many as 449,661 devices. The recall does not impact patients who have successfully undergone treatment with the devices, according to Abbott Vascular, wrote FierceBiotech.com.
Abbott Vascular pointed out that physicians might experience challenges removing the balloon sheath from the recalled devices. Also, should “excessive force” be used, this may lead to problems in inflating or deflating the catheter balloon. This might result in an air embolism or the blockage of a blood vessel by an air bubble, blood clot, thrombosis (arterial clot), myocardial infarction (heart attack), death, or the need for additional intervention, FierceBiotech.com reported.
Abbott advised customers to “immediately stop using the devices,” review their inventory, and return all of their unused devices to Abbott. Abbott Vascular also indicated that it took corrective measures to ensure the catheters work as intended and is working with customers to replace the affected devices with a similar product.
The FDA noted that the distribution dates are from January 1, 2015 to March 14, 2017 and the recall involves 132,040 devices distributed in the United States. According to the agency, Abbott’s Coronary Dilatation Catheters are indicated for use in the following cardiac procedures: balloon dilatation of
- the stenotic portion of a coronary artery or bypass graft stenosis to improve blood flow to the heart;
- a coronary artery occlusion (blocked, clogged artery) to restore coronary blood flow in patients diagnosed with ST-segment elevation myocardial infarction (heart attack); and
- a stent after implantation (2.00 mm – 5.00 mm balloon models only).
Abbott Vascular’s “Field Safety Notice” letter to health care providers and risk managers advised of the various catheters’ risks, as well as corrective actions that Abbott Vascular intends on implementing to ensure ongoing product performance. The letter asked health care providers and risk managers to:
- Reference the list of affected part and lot numbers.
- Cease using the devices from the identified lots; remove or quarantine them.
- Contact Abbott Vascular to obtain a Return Authorization Number.
- Return all affected and unused products to Abbott Vascular.
- Acknowledge receipt of the notification
- Return the “Effectiveness Check Form” provided by Abbott Vascular by email or fax.
- Share notification with other relevant personnel in the organization.
According to MedPageToday, there has been one fatal case, to date, that involved a recalled device’s failure to deflate the balloon during required surgery that was accompanied by multiple complications that ultimately lead to death.
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 catheter lawsuit.
Catheter’s Have Long Been Associated with Defects, Injuries
A catheter is a flexible plastic tube that is inserted in the body to either collect or deliver fluid. One example is a urinary catheter, which collects urine from the bladder. A cardiac catheter delivers a special dye that is visible during an X-ray. Over the past year, a variety of medical device manufacturers have recalled a combined four million catheters, dozens of patients have reported injuries, and two wrongful death lawsuits have been filed due to broken catheters. In most cases, the catheter tips have fractured or other parts of the catheters have separated within the patient’s body, a condition that may lead to serious injury or death.
On April 15, 2017, Cook Medical issued the largest catheter recall, to date, recalling over 4.1 million Beacon-Tip catheters over risks that the tip might break off. At the time of the recall, the FDA reported no less than 30 injuries.
On April 19, 2017, Boston Scientific issued a recall over its Fetch 2 Aspiration Catheter because the shaft could break during surgery conducted to remove blood clots.
On December 9, 2016 a recall was issued for Centurion Convenience Kits that contained Multi-Med Single Lumen Catheters. These were used to draw blood or administer medications or fluids. According to the FDA, “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.”
On October 4, 2016, Vascular Solutions Twin-Pass Dual Access catheters were recalled because the catheters had excess material in the tip, which poses a risk of blood clots and death.
On November 30, 2016, Medtronic recalled various catheters used to treat blood clots in the brain. The coating on the catheter could peel off and enter the bloodstream, causing blood clots. That recall included the Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, UltraFlow micro-catheters, and Marathon micro-catheters, according to The Wall Street Journal.
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, please 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).