Possis Medical, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Possis Medical, Inc
Lot Codes / Batch Numbers
model number: 105421-002, Lot number 56594
Products Sold
model number: 105421-002, Lot number 56594
Possis Medical, Inc is recalling AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026