—#140960

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.

FDA product code: MCX — Catheter, Coronary, Atherectomy
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P900056
Affected lot / code info: Lots: 18141187, 18194620, 18220238, 18261834, 18285502, 18303265, 18390089

Why it was recalled

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.

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 2 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-10-09
Posted by FDA: 2015-11-13
Terminated: 2017-10-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140960. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.