Class 1 Device Recall RotaWire Elite and sireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy

• Date Initiated by Firm: October 09, 2015
• Date Posted: November 13, 2015
• Recall Status: Terminated on October 13, 2017
• Recall Number: Z-0211-2016
• Recall Event ID: 72409
• PMA Number: P900056
• Product Classification: Catheter, coronary, atherectomy - Product Code MCX
• Product: RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (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.
• Code Information: Lots: 18201519, 18212726, 18256610, 18261218, 18271412, 18282032, 18362094, 18378161, 18379210, 18384443
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 2 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: Nicole Pshon; 763-494-1556
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Component change control
• Action: The firm, Boston Scientific, sent an "Urgent Medical Device Recall Removal - Immediate Action Required" letter dated 10/9/2015. Letters were sent via overnight delivery (FedEx or other equivalent service). The letter stated the issue, identified affected devices, stated that further distribution or use of the devices should cease immediately, and affected product should be returned to Boston Scientific in accordance with the enclosed recall instructions. Complete and return the Recall Instructions via email: MapleGroveFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806. Healthcare professionals and consumer may report serious adverse events (side effects ) or product quality problems with the use of this product to Boston Scientific by calling 1-800-811-3211. If you have any questions, please contact Boston Scientific Quality Systems at 763-494-1133, email: MapleGroveFieldActionCenter@bsci.com or your local sales representative can answer any questions that you may have regarding this recall removal.
• Quantity in Commerce: 955 single units (191 5-packs)
• Distribution: Worldwide Distribution: US Distribution in the states of AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, and WI, and the countries of Belgium, Germany, Great Britain, Italy, Japan, and South Africa.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MCX and Original Applicant = Boston Scientific Corp.