Z-0469-06

AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use...

Name: Z-0469-06 AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use...
Creator: Possis Medical, Inc
Published: 2005-12-12
License: https://open.fda.gov/license/

Possis Medical, Inc. / initiated 2005-12-12 / Terminated / root cause: packaging

FDA source

Possis Medical, Inc began a recall of AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only... on 2005-12-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0469-06
Status: Terminated
Initiated: 2005-12-12
Posted: 2006-02-04
Terminated: 2006-11-08
Recalling firm: Possis Medical, Inc.
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.
Product code: DXE Catheter, Embolectomy
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.
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 48
Distribution: Lot was distributed to 3 OUS distributors located in Italy, United Kingdom and Netherlands.
Product codes and lots: model number: 105421-002, Lot number 56594

Product code DXE

K042874Class IIAngiojet Xmi Catheter - Rapid Exchange (Xmi-Rx)Possis Medical, Inc. / cleared 2004-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)