Recall Z-0212-2016— Boston Scientific Corporation

Class I FDA medical device recall by Boston Scientific Corporation, initiated 2015-10-09, terminated 2017-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). 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 guidewires are intended for use with the Rotablator Rotational Atherectomy System.. Reason: Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture..

Recalling firm

Boston Scientific Corporation

Classification

Class I

Status

Terminated

Initiated

2015-10-09

Terminated

2017-10-13

Firm location

Maple Grove, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.