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U.S. Department of Health and Human Services

Class 2 Device Recall Protg "GPS" SelfExpanding Biliary Stent System

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  Class 2 Device Recall Protg "GPS" SelfExpanding Biliary Stent System see related information
Date Initiated by Firm October 30, 2010
Date Posted December 16, 2010
Recall Status1 Terminated 3 on March 29, 2012
Recall Number Z-0626-2011
Recall Event ID 57112
510(K)Number K050725  
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¿g¿ " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only.

ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¿g¿ " GPS" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only.
Code Information Lot 9199844 (REF SERB65-12-60-80) & 9199842 (REF SERB65-14-60-80).
Recalling Firm/
Manufacturer		 Ev3, Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact
763-398-7000
Manufacturer Reason
for Recall		 Mislabeled size: Specific Prot¿g¿ GPS lots have product labeling that does not match the actual stent sizes contained in the packages. The affected product outer packaging is labeled as a 12 mm x 60 mm Prot¿g¿ GPS stent but contains a 14 mm x 60 mm stent. This situation can potentially result in vessel damage. Conversely, a lot was labeled as a 14 mm x 60 mm Prot¿g¿ GPS stent but actually contai
FDA Determined
Cause 2		 Packaging process control
Action ev3 issued a "Medical Device Recall" letter dated September 29, 2010 to consignees. The letter described the product, Issue Summary, & Required Action. Consignees are to review inventory and remove all affected devices. ev3 representatives will contact customers to arrange for the return and credit of unused product. ev3 can be reached at 800 716-6700 concerning this recall.
Quantity in Commerce 30
Distribution Nationwide Distribution: including the states of AZ, DE, C, FL, GA, ID, IL, IN,LA, MN, MO, NJ, NY, NC, OH, 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 CORPORATION
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