Boston Scientific Corporation: Medical Device Recall in 2015 - (Recall #: Z-0211-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: October 9, 2015

Date Posted: November 18, 2015

Recall Number: Z-0211-2016

Event ID: 72409

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.

Status: Terminated

Product Quantity: 955 single units (191 5-packs)

Code Information:

Lots: 18201519, 18212726, 18256610, 18261218, 18271412, 18282032, 18362094, 18378161, 18379210, 18384443

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.

Voluntary or Mandated:

Voluntary: Firm initiated