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Class 1 Device Recall TrailBlazer Support Catheter |
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Date Initiated by Firm |
November 06, 2009 |
Date Posted |
December 23, 2009 |
Recall Status1 |
Terminated 3 on January 05, 2011 |
Recall Number |
Z-0497-2010 |
Recall Event ID |
53879 |
510(K)Number |
K092299
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Product Classification |
Percutaneous Catheter - Product Code DQY
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Product |
TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO.
US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, and SC-035-150.
Intended to guide and support a guide wire during access of the vasculature.
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Code Information |
Lot #: 7828282, 7792290, 7792584, 7805570, 7805797, 7806392, 7820252, 7790666, 7791887, 7803307, 7835331, 7822400, 7822593, 7800446, 7800555, 7800756, 7800779, 7800809, 7801822, 7801875, 7803305, 7803306, 7820273, 7834779, 7834845, 7824905, and 7832205. |
Recalling Firm/ Manufacturer |
Ev3, Inc. 4600 Nathan Ln N Plymouth MN 55442-2890
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For Additional Information Contact |
763-398-7000
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Manufacturer Reason for Recall |
Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential embolization.
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FDA Determined Cause 2 |
Component design/selection |
Action |
Consignees were sent a Medical Device Recall letter, dated 11/6/09. The letter was addressed to Risk Manger or Cath Lab Manage. The letter provided the Issue Summary, identified the Affected Product, and stated the Required Action, which asked consignees to locate and remove the affected product. Questions should be directed to ev3 Customer Service at 800-716-6700. |
Quantity in Commerce |
70 |
Distribution |
Nationwide Distribution -- USA, including states of CA, FL, GA, IL, IN, IA, KS, KY, MI, MT, NJ, PA, SD, TN, TX, and WI. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DQY and Original Applicant = EV3 INC
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