Medtronic Inc. Cardiac Rhythm Disease Management: Medical Device Recall in 2013 - (Recall #: Z-1017-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 13, 2013

Date Posted: April 3, 2013

Recall Number: Z-1017-2013

Event ID: 64620

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.

Status: Terminated

Product Quantity: 225 units

Code Information:

Lot number GFWA0387

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.

Voluntary or Mandated:

Voluntary: Firm initiated