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U.S. Department of Health and Human Services

Class 2 Device Recall Protg EverFlex" SelfExpanding Biliary Stent System

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  Class 2 Device Recall Protg EverFlex" SelfExpanding Biliary Stent System see related information
Date Initiated by Firm March 31, 2010
Date Posted May 13, 2010
Recall Status1 Terminated 3 on March 08, 2012
Recall Number Z-1598-2010
Recall Event ID 55303
510(K)Number K060057  
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product ev3 Prot¿g¿ EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929.

Intended as a palliative treatment of malignant neoplasms in the biliary tree.
Code Information Lot Numbers: 7857377, 7856788 and 7858698.
Recalling Firm/
Manufacturer		 Ev3, Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact
763-398-7000
Manufacturer Reason
for Recall		 ev3 is conducting a voluntary recall on three lots of the Prot¿g¿ EverFlex" Biliary Stent System. They determined that a lot of 120mm Prot¿g¿ EverFlex" Biliary Stent system may contain a 150mm length Self-Expanding stent and two lots o 150mm Prot¿g¿ EverFlex" Biliary Stent System may contain a 120 mm length Self-Expanding stent.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action ev3 issued "Medical Device Recall" notifications dated March 31, 2010 addressed to "Dear Risk Manager or Cath Lab Manager". Each letter addressed the affected product. Users were instructed to locate and remove from use the affected product and a sales representative will be in contact shortly to arrange for return. For further information, contact ev3 Customer Service at 1-800-716-6700.
Quantity in Commerce 19
Distribution Nationwide Distribution -- CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA.
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 = FGE and Original Applicant = EV3 INC.
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