Boston Scientific recalled its RotaWire Elite Guidewires and wireClip Torquer Guidewires after receiving three reports of the wires cracking and separating from the Rotablator Rotational Atherectomy System.
Boston Scientific sent a recall letter beginning on Oct. 9 to customers telling them to immediately stop distributing and using the devices and return the affected products to Boston Scientific.
The FDA announced the recall on Nov. 27 and classified it as a Class I recall, which is the most serious type of recall.
In its recall letter, Boston Scientific mentioned the wires might crack and separate from the rest of the system and cause serious injury such as MI, tamponade and migration of wire fragments elsewhere in the body.
Of the three reports, one resulted in a patient dying after undergoing a medical intervention to remove the broken wire. When the issue has occurred, interventions have included occluding the affected artery, placing stents in the affected artery and performing emergency heart surgery.
The recall included 600 devices in 17 states that were manufactured from June 26, 2015 to Sept. 10, 2015 and distributed from July 9, 2015 to Oct. 1, 2015.