AngioJet 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.
FDA Recall Z-0469-06 · Posted 2006-02-04
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Recalling FirmPossis Medical, Inc
Recall StatusTerminated
Product CodeDXE
Date Initiated2005-12-12
Date Terminated2006-11-08
Product Quantity48
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.
Firm Action
An 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.
Root Cause
Other
Distribution Pattern
Lot was distributed to 3 OUS distributors located in Italy, United Kingdom and Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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