Recall Z-1017-2013— Medtronic Inc. Cardiac Rhythm Disease Management

Name: FDA recall Z-1017-2013
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 2013-11-21. It names one FDA 510(k) clearance: K101339. Product: Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.. Reason: Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use..

Recalling firm: Medtronic Inc. Cardiac Rhythm Disease Management
Classification: Class II
Status: Terminated
Initiated: 2013-03-13
Terminated: 2013-11-21
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 Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.

Reason for recall

Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.

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