Boston Scientific Heart Device Wires under Class 1 RecallDec 1, 2015
Boston Scientific Corp. has recalled 600 units of RotaWire Elite core wires and wireClip Torquer Guidewires, which may crack and separate from the Rotablator Rotational Atheroctomy System apparatus and cause serious injury to the patient.
The Rotablator Rotational Atheroctomy System is used to open narrowed arteries and improve blood flow to the heart. If the RotaWire Elite core wires or wireClip Torquer Guidewires 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, the Food and Drug Administration (FDA) explains.
This recall is designated as Class 1, the FDA's most serious recall category, reserved for situations where use of the recalled product may cause serious adverse health consequences, including death.
According to the recall announcement, Boston Scientific has received three reports of problems with the wires and one patient died after medical intervention to remove the broken wire. In other cases, interventions have included blocking off (occluding) the affected artery, placing stents into the affected artery, and emergency heart surgery.
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. 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.
On October 9, 2015, Boston Scientific began sending Urgent Medical Device Recall letters to customers, instructing them to immediately stop distributing and using the devices. The letter included instructions for returning the recalled wires to Boston Scientific. Distributors were asked to notify any customer who may have received the recalled wires. Customers may return the Recall Removal Reply Verification Tracking Form to Boston Scientific via email: firstname.lastname@example.org, or by fax: 1-866-213-1806.