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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 Device Recall TrailBlazer Support Cathetersee related information
Date Initiated by FirmNovember 06, 2009
Date PostedDecember 23, 2009
Recall Status1 Terminated 3 on January 05, 2011
Recall NumberZ-0497-2010
Recall Event ID 53879
510(K)NumberK092299 
Product Classification Percutaneous Catheter - Product Code DQY
ProductTrailBlazer 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.
FEI Number 2183870
Recalling Firm/
Manufacturer		 Ev3, Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact
763-398-7000
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		Component design/selection
ActionConsignees 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 Commerce70
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = DQY
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