Recall Z-0955-2007 ยท DXE Catheter, Embolectomy
Possis Medical, Inc
Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-- (XMI - Rapid Exchange Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).
| Date | Jun 21, 2007 (initiated May 1, 2007) |
| Status | Terminated |
| Reason | Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters. |
| Root cause | Other |
| Action | Consignees were notified of the problem on May 1, 2007 via a Urgent Medical Device Recall Letter. The consignees were instructed to quarantine the product until a Possis Representative contacts them. The representative will examine the units and determine which ones to be returned to Possis. They were also asked to fill and return the attached form. |
| Quantity | 45 |
| Distribution | Nationwide including states of AK, AR, AZ, CA, CT, FL,IL, IN, KY, MD, ME, MI, MN, MS, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042874 | ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) Possis Medical, Inc., Nov 5, 2004 |