Boston Scientific Corp. has recalled RotaWire Elite core wires, part of a system used to open narrowed arteries and improve blood flow to the heart because the wires may crack and separate from the apparatus and cause serious injury to the patient.
If the wires of the Rotablator Rotational Atheroctomy System crack and separate, injuries can include tamponade (blood in the sac around the heart causing decreased heart function), myocardial infarction (heart attack), and migration of wire fragments elsewhere in the body, according to the Food and Drug Administration (FDA).
Boston Scientific has received three reports of this issue occurring; one patient died following medical intervention to remove the broken wire. Other interventions have included purposefully blocking off (occluding) the affected artery, placing stents into the affected artery, and emergency heart surgery.
The FDA has designated this a Class 1 recall, the agency’s most serious category. Use of the recalled product may cause serious adverse health consequences, including death.
The RotaWire Elite Guidewire and wireClip Torquer Guidewire are components of the Rotablator Rotational Atherectomy System. The device is used to open narrowed arteries and improve blood flow to the heart by cutting plaque from the artery wall, the FDA explains.
According to the recall notice on the FDA web site, the recalled RotaWire Elite Guidewires and wireClip Torquer Guidewires were manufactured between June 26 and September 10, 2015 and were distributed from July 9 to October 1, 2015. Six hundred units were recalled.
Boston Scientific began sending Urgent Medical Device Recall letters to customers on October 9, 2015. The letter instructed customers to immediately stop distributing and using the devices and return the recalled products to Boston Scientific following the recall instructions in the letter. The letter directed distributors to notify any customer who may have received the product. Customers may return the Recall Removal Reply Verification Tracking Form to Boston Scientific via email: email@example.com, or by fax: 1-866-213-1806.