Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-1017-2013

Z-1017-2013 Class II Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

FDA device recall Z-1017-2013 was initiated by Medtronic Inc. Cardiac Rhythm Disease Management on March 13, 2013 and is designated Class II. 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 w… The recall status is terminated (terminated November 21, 2013). Affected quantity: 225 units.

Recall Details

Product Type
Devices
Report Date
April 3, 2013
Initiation Date
March 13, 2013
Termination Date
November 21, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
225 units

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.

Distribution Pattern

Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.

Code Information

Lot number GFWA0387

Other recalls by Medtronic Inc. Cardiac Rhythm Disease Management

  • Z-0022-2016 Class II — Medtronic Medical Device Identification Card for SureScan pacemaker patients. (September 15, 2015)
  • Z-2777-2015 Class II — Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing c (September 1, 2015)
  • Z-1365-2015 Class II — Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx onl (March 23, 2015)
  • Z-1356-2015 Class II — Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Us (March 17, 2015)
  • Z-1276-2015 Class I — Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Se (February 23, 2015)
  • Z-1661-2014 Class II — Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generat (April 29, 2014)
  • Z-0995-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (January 30, 2014)
  • Z-0997-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vent (January 30, 2014)
  • Z-0998-2014 Class II — Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 ( (January 30, 2014)
  • Z-1000-2014 Class II — Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Art (January 30, 2014)

FDA data resources