Z-0211-2016Class I

RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301...

Name: Z-0211-2016 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301...
Creator: Boston Scientific Corporation
Published: 2015-10-09
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2015-10-09 / Terminated

FDA source

Boston Scientific Corporation began a recall of RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit)... on 2015-10-09. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0211-2016
Classification: Class I
Status: Terminated
Initiated: 2015-10-09
Posted: 2015-11-13
Terminated: 2017-10-13
Recalling firm: Boston Scientific Corporation
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.
Product code: MCX Catheter, Coronary, Atherectomy
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 root 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: [email protected] 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: [email protected] 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.
Product codes and lots: Lots: 18201519, 18212726, 18256610, 18261218, 18271412, 18282032, 18362094, 18378161, 18379210, 18384443

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0211-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0211-2016	Class I	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-12
Z-0212-2016	Class I	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-12

Product code MCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)