Boston Scientific recall of its cardiology guidewire deemed Class 1 by FDA

Rotawire--Courtesy of Boston Scientific

The FDA just publicized the voluntary Class 1 recall of Boston Scientific's RotaWire Elite and wireClip Torquer Guidewire and Guidewire Manipulation Device because of complaints of wire fracture, including one case that resulted in a fatality.

Boston Scientific ($BSX) recalled 955 units of the device in field notice published October, spanning from the U.S. to Italy to Japan to South Africa, according to a recall notice in FDA's database. The guidewire is distributed in packaging containing 5 units apiece.

"One fracture occurred during device prep, and the other two fractures occurred during the procedure resulting in burr migration into the pericardium. One of these involved placement of a covered stent to address vessel perforation. That patient subsequently expired. The other required surgery for removal of the fragment," the letter, posted on the website of Germany's Federal Institute for Drugs and Medical Devices, says.

The letter calls on hospitals to stop using the affected devices and return them to Boston Scientific immediately. It contains the lot numbers of the affected devices, as does the recall notice in the FDA's database.

"In August, Boston Scientific voluntarily recalled all of its RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation Device due to the possibility of wire fracture. These devices were in limited distribution and we have contacted all of the affected hospitals accordingly. Please note that this action does not apply to original RotaWire Guidewires," Boston Scientific said in an emailed statement.

The guidewire is used in conjunction with the Rotablator Rotational Atherectomy System. "The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended," the FDA explains in the recall notice.

Recalls deemed Class 1 by the FDA are the most serious and reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

Last year, Boston Scientific announced a collaboration with Japanese medical components specialist Asahi Intecc to launch launch new fractional flow reserve and atherectomy guidewires. A Boston Scientific spokesman told FierceMedicalDevices that the alliance has so far resulted in the launch of the Comet Pressure Guidewire for fractional flow reserve devices, which make measurements that guide treatment decisions in heart failure patients.

- here's the letter (PDF)
- read the recall notice in FDA's database

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