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U.S. Department of Health and Human Services

Class 3 Device Recall Possis AngioJet Rheolytic Thrombectomy SystemSpiroflex Catheter

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  Class 3 Device Recall Possis AngioJet Rheolytic Thrombectomy SystemSpiroflex Catheter see related information
Date Initiated by Firm May 01, 2007
Date Posted June 21, 2007
Recall Status1 Terminated 3 on July 15, 2007
Recall Number Z-0954-2007
Recall Event ID 37919
PMA Number P989937 
Product Classification Coronary Catheter - Product Code MCX
Product Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-
(Spiroflex Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).
Code Information Model #: 105835-001 Lot # 73082
Recalling Firm/
Manufacturer		 Possis Medical, Inc
9055 Evergreen Blvd Nw
Minneapolis MN 55433-5833
Manufacturer Reason
for Recall		 Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters.
FDA Determined
Cause 2		 Other
Action Consignees were notified of the problem on May 1, 2007 via a Urgent Medical Device Recall Letter. The consignees were instructed to quarantine the product until a Possis Representative contacts them. The representative will examine the units and determine which ones to be returned to Possis. They were also asked to fill and return the attached form.
Quantity in Commerce 69
Distribution Nationwide including states of AK, AR, AZ, CA, CT, FL,IL, IN, KY, MD, ME, MI, MN, MS, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, WA, and WI.
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.
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