Z-0265-2014Class I

ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to...

Name: Z-0265-2014 ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to...
Creator: Medtronic Vascular
Published: 2013-10-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-10-21 / Terminated / root cause: manufacturing process

FDA source

Medtronic Vascular began a recall of ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous... on 2013-10-21. FDA classified it as Class I and gives the reason as "Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0265-2014
Classification: Class I
Status: Terminated
Initiated: 2013-10-21
Posted: 2013-11-15
Terminated: 2014-12-15
Recalling firm: Medtronic, Inc.
Product: ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required). Should have any questions, please contact your Medtronic Representative or call 763-526-2513. Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming their receipt of the notification. 100% customer confirmations will be required from the additional consignees.
Quantity in commerce: 1674
Distribution: Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.
Product codes and lots: 0006752371 0006752383 0006752385 0006759937 0006759939 0006759941 0006769772 0006781453 0006781454 0006781455 0006808160 0006808161 0006808164 0006808165 0006808166 0006808167 0006831243 0006840866 0006840878 0006840879 0006866694 0006866696 0006866697 0006873688 0006873692 0006873694

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0265-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0261-2014	Class I	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0262-2014	Class I	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0263-2014	Class I	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0264-2014	Class I	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0265-2014	Class I	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0266-2014	Class I	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0267-2014	Class I	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0268-2014	Class I	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15

Product code DQX

K063210Class IIAttain Hybrid Guide Wires, Model Gwr419378, Gwr419388, Gwr419478, Gwr419488Medtronic Inc. Cardiac Rhythm Management / cleared 2007-03-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)