Recall Z-0497-2010 ยท DQY Catheter, Percutaneous
Ev3, Inc.
TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, and SC-035-150. Intended to guide and support a guide wire during access of the vasculature.
| Date | Dec 23, 2009 (initiated Nov 6, 2009) |
| Status | Terminated |
| Reason | Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential embolization. |
| Root cause | Component design/selection |
| Action | Consignees were sent a Medical Device Recall letter, dated 11/6/09. The letter was addressed to Risk Manger or Cath Lab Manage. The letter provided the Issue Summary, identified the Affected Product, and stated the Required Action, which asked consignees to locate and remove the affected product. Questions should be directed to ev3 Customer Service at 800-716-6700. |
| Quantity | 70 |
| Distribution | Nationwide Distribution -- USA, including states of CA, FL, GA, IL, IN, IA, KS, KY, MI, MT, NJ, PA, SD, TN, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092299 | TRAILBLAZER SUPPORT CATHETER Ev3, Inc., Aug 7, 2009 |