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U.S. Department of Health and Human Services

Class 2 Device Recall Archer Super Stiff Guidewire

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 Class 2 Recall
Archer Super Stiff Guidewire
see related information
Date Posted March 28, 2013
Recall Status1 Terminated on November 21, 2013
Recall Number Z-1017-2013
Recall Event ID 64620
Premarket Notification
510(K) Number
K101339 
Product Classification Wire, Guide, Catheter - Product Code DQX
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.
Code Information Lot number GFWA0387
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul, Minnesota 55112-4391
For Additional Information Contact Medtronic Customer Service
763-526-6000
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action Medtronic sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Medtronic requested any unused guidewires from the lot number to be quarantined, and returned by contacting the customer service phone number at 1-888-283-7868. A Customer Confirmation Certificate was requested to be faxed back to Medtronic at 651-367-0612.
Quantity in Commerce 225 units
Distribution Worldwide Distribution-USA including the states of FL, OH, and MN and the countries of Belgium, France Germany, Netherlands, Turkey, and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = MEDTRONIC INC.
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