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U.S. Department of Health and Human Services

Class 2 Device Recall AngioJet XVG Thrombectomy Catheter

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  Class 2 Device Recall AngioJet XVG Thrombectomy Catheter see related information
Date Initiated by Firm June 19, 2007
Date Posted August 10, 2007
Recall Status1 Terminated 3 on March 02, 2008
Recall Number Z-1131-2007
Recall Event ID 38244
510(K)Number K050794  
Product Classification Catheter - Product Code DXE
Product Possis AngioJet XVG Thrombectomy Sets,
Model/Order # 105042-001, Sterilized with Ethylene Oxide,
Possis Medical, Inc., 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003. (These sets are used with the new AngioJet Ultra Console)
Code Information 71851, 71852, 71997, 72086, 72539, 73170, 73171, 73646, 73758.
Recalling Firm/
Manufacturer		 Possis Medical, Inc
9055 Evergreen Blvd Nw
Minneapolis MN 55433-5833
Manufacturer Reason
for Recall		 Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary vessels. These units should indicated use only for peripheral arteries.
FDA Determined
Cause 2		 Other
Action A Urgent Medical Device recall letter dated 19 June 2007, was sent to consignees advising that all unused product be removed and returned to Possis. An acknowledgement of the disposiiton of the product will be requested from consignees.
Quantity in Commerce 194
Distribution AR, AZ, CA, FL, GA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI, WV
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 = DXE and Original Applicant = POSSIS MEDICAL, INC.
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