Recall Z-1131-2007 ยท DXE Catheter, Embolectomy
Possis Medical, Inc
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)
| Date | Aug 10, 2007 (initiated Jun 19, 2007) |
| Status | Terminated |
| Reason | 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 | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050794 | ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER Possis Medical, Inc., Apr 28, 2005 |