Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using et

FDA device recall Z-1019-2013 · posted 2013-03-28 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

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.

Action taken

Medtronic sent an Urgent Medical Device Recall letter dated March 2013 to all affected customers. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to immediately quarantine all affected products and returned to Medtronic. Customers were requested to complete the attached Customer Confirmation Certificate and fax it to Medtronic to the attention of Customer Focused Quality. For question contact your local Medtronic representative or Medtronic Customer Service at 1-888-283-7868.

Root cause

Component change control

Status

Terminated

Product code

DQX

Quantity affected

27,682 devices

Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Canada, Chile, China, Colombia, Croatia, Czech Republic,

Date initiated

2013-03-13

Date posted

2013-03-28

Date terminated

2014-02-06

Location

Saint Paul, MN

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