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U.S. Department of Health and Human Services

Class 3 Device Recall AngioJet XMI RX

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 Class 3 Device Recall AngioJet XMI RXsee related information
Date Initiated by FirmDecember 12, 2005
Date PostedFebruary 04, 2006
Recall Status1 Terminated 3 on November 08, 2006
Recall NumberZ-0469-06
Recall Event ID 34214
510(K)NumberK042874 
Product Classification Catheter, Embolectomy - Product Code DXE
ProductAngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 USA.
Code Information model number: 105421-002, Lot number 56594
Recalling Firm/
Manufacturer		 Possis Medical, Inc
9055 Evergreen Blvd Nw
Minneapolis MN 55433-5833
Manufacturer Reason
for Recall		It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model.
FDA Determined
Cause 2		Other
ActionAn Advisory Notice was emailed to OUS Distributors 12/12/2005. The Advisory identifies the product, reason for recall and action Distributor should take. Distributors are to notify their customer who received the affected lot and return it to the Distributor. The Distributor is to open the outer box and inspect the catheter inside the sterile tray. Mislabeled units are to be returned to Possis.
Quantity in Commerce48
DistributionLot was distributed to 3 OUS distributors located in Italy, United Kingdom and Netherlands.
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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