Recall Z-1019-2013— Medtronic Inc. Cardiac Rhythm Disease Management

Name: FDA recall Z-1019-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-13

Class II · Terminated

Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2013-03-13, terminated 2014-02-06. It names one FDA 510(k) clearance: K101339. Product: Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.. Reason: Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use..

Recalling firm: Medtronic Inc. Cardiac Rhythm Disease Management
Classification: Class II
Status: Terminated
Initiated: 2013-03-13
Terminated: 2014-02-06
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K101339 — ARCHER SUPER STIFF GUIDEWIRESMedtronic, Inc.·cleared 2010-08-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.

Reason for recall

Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.