ev3 Protg 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.
FDA Recall Z-1598-2010 · Posted 2010-05-13
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Recalling FirmEv3, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2010-03-31
Date Terminated2012-03-08
Product Quantity19
Reason for Recall
ev3 is conducting a voluntary recall on three lots of the Protg EverFlex" Biliary Stent System. They determined that a lot of 120mm Protg EverFlex" Biliary Stent system may contain a 150mm length Self-Expanding stent and two lots o 150mm Protg EverFlex" Biliary Stent System may contain a 120 mm length Self-Expanding stent.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Nationwide Distribution -- CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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