Date Initiated by Firm |
March 13, 2013 |
Date Posted |
March 28, 2013 |
Recall Status1 |
Terminated 3 on November 21, 2013 |
Recall Number |
Z-1017-2013 |
Recall Event ID |
64620 |
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 MN 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 |
Mixed-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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DQX and Original Applicant = MEDTRONIC INC.
|