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U.S. Department of Health and Human Services

Class 1 Device Recall TrailBlazer Support Catheter

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 Class 1 Recall
TrailBlazer Support Catheter
see related information
Date Posted December 23, 2009
Recall Status1 Terminated on January 05, 2011
Recall Number Z-0497-2010
Recall Event ID 53879
Premarket Notification
510(K) Number
Product Classification Catheter, Percutaneous - Product Code DQY
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.
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/
Ev3, Inc.
4600 Nathan Ln N
Plymouth, Minnesota 55442-2890
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.
FDA Determined
Cause 2
DESIGN: 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

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 = DQY and Original Applicant = EV3 INC