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U.S. Department of Health and Human Services

Class 3 Device Recall Possis AngioJet XMI Catheter Rapid Exchange

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 Class 3 Device Recall Possis AngioJet XMI Catheter Rapid Exchangesee related information
Date Initiated by FirmMay 01, 2007
Date PostedJune 21, 2007
Recall Status1 Terminated 3 on July 15, 2007
Recall NumberZ-0955-2007
Recall Event ID 37919
510(K)NumberK042874 
Product Classification Coronary Catheter - Product Code DXE
ProductAngiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-- (XMI - Rapid Exchange Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).
Code Information Model # 104504-001 Lot Nos: 72285 and 72794
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
ActionConsignees 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 Commerce45
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = DXE
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