RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack

FDA device recall Z-0212-2016 · posted 2015-11-13 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

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.

Root cause

Component change control

Status

Terminated

Product code

MCX

Quantity affected

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

Date initiated

2015-10-09

Date posted

2015-11-13

Date terminated

2017-10-13

Location

Maple Grove, MN