Z-1131-2007

Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene Oxide, Possis...

Name: Z-1131-2007 Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene Oxide, Possis...
Creator: Possis Medical, Inc
Published: 2007-06-19
License: https://open.fda.gov/license/

Possis Medical, Inc. / initiated 2007-06-19 / Terminated / root cause: labeling and UDI

FDA source

Possis Medical, Inc began a recall of Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene Oxide, Possis Medical, Inc., 9055 Evergreen Boulevard NW... on 2007-06-19. The reason FDA records is "Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1131-2007
Status: Terminated
Initiated: 2007-06-19
Posted: 2007-08-10
Terminated: 2008-03-02
Recalling firm: Possis Medical, Inc.
Product: Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene Oxide, Possis Medical, Inc., 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003. (These sets are used with the new AngioJet Ultra Console)
Product code: DXE Catheter, Embolectomy
Reason for recall: Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary vessels. These units should indicated use only for peripheral arteries.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A Urgent Medical Device recall letter dated 19 June 2007, was sent to consignees advising that all unused product be removed and returned to Possis. An acknowledgement of the disposiiton of the product will be requested from consignees.
Quantity in commerce: 194
Distribution: AR, AZ, CA, FL, GA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, WA, WI, WV
Product codes and lots: 71851, 71852, 71997, 72086, 72539, 73170, 73171, 73646, 73758.

Product code DXE

K050794Class IIAngiojet Dvx Rheolytic Thrombectomy CatheterPossis Medical, Inc. / cleared 2005-04-28

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)