FDA announces recall of Boston Scientific interventional radiology devices, citing risk of serious injury or death
The U.S. Food and Drug Administration has announced the recall of a Boston Scientific product used in interventional radiology procedures, citing the risk of possible injury or death.
Its alert pertains to over 26,000 Carotid Wallstent Monorail Endoprosthesis devices, utilized by interventional neuroradiologists, vascular surgeons and other docs as a minimally invasive approach to treat carotid artery stenosis and prevent strokes.
Boston Scientific is recalling the stent due to a manufacturing defect that created an inner lumen smaller than specifications. This has caused resistance when doctors withdraw the stent delivery system, the FDA said in a notice updated on Aug. 22.
“Using the affected stent systems could cause serious harm, such as injury to the blood vessel, damage to the stent or release of debris that could travel to the brain and cause a stroke,” the notice reads.
This is a Class 1 recall, the agency’s most serious designation, meaning misuse of the product could result in “serious injury or death if you continue to use it.” As of July 29, Boston Scientific had reported six cases that required additional intervention to recover the device, but no fatalities.
In a July 7 notice, the Marlborough, Massachusetts-based vendor directed providers to immediately stop using the impacted devices. Radiologists and other physicians also are urged to segregate the items from other inventory and return them to Boston Scientific. The vendor said it has received an increase in complaints in which physicians have encountered “greater than anticipated resistance” while attempting to withdraw the stent delivery system from the guidewire or embolic protection device. Stroke is the most serious potential adverse consequence, with other risks including procedure delays, vessel injuries, vessel spasms, or stent disruption or damage.
Carotid artery stenting is aimed at preventing a stroke, according to the Cleveland Clinic. Radiologists and other physicians perform the procedure if a carotid ultrasound, CT scan or MRI shows a blockage in the artery, which supplies blood to the brain, face and neck. These small, metal, mesh tubes are inserted to allow for better blood flow to the brain, acting as a scaffold to support the artery and keep it open. Boston Scientific’s product is a self-expanding stent, placed using a catheter over a guidewire or embolic protection device, the FDA noted.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.