Dive Brief:
- Boston Scientific has recalled carotid artery stents because of a manufacturing defect that has led to additional interventions to recover the devices.
- The Food and Drug Administration, which shared information about the recall Friday, said the company reported six cases that required additional intervention as of July 29.
- Boston Scientific told customers not to use affected Carotid Wallstent Monorail Endoprosthesis devices last month. The recall affected 26,570 devices, 1,333 of which are in the U.S.
Dive Insight:
Physicians use the self-expanding stents to open narrowed carotid arteries. The device is placed using a catheter over a guidewire or embolic protection device. The delivery system triggered the recall.
The FDA said a manufacturing defect “created an inner lumen smaller than specifications, causing resistance when withdrawing the stent delivery system.” The agency provided more details in a Class 1 recall database entry earlier this month, reporting that there was an increase in complaints from physicians about greater than anticipated resistance during withdrawal from the guidewire or embolic protection device.
Using stent systems with the manufacturing defect 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 FDA said. Boston Scientific had not reported any deaths linked to the issue as of July 29. The FDA said stroke is the most serious potential adverse health consequence.
The potential for harm led the company to tell customers to stop using the affected devices immediately. Boston Scientific wants users to remove all the recalled stents from their inventories and return them to the company.
Boston Scientific won premarket approval for the device in 2008. The company received approval for a change to a delivery system component coating process last year. The recent withdrawal of lots because of the manufacturing defect is the only entry for the stent in the FDA’s medical device recall database.
