Recall Z-2190-2010 ยท DXE Catheter, Embolectomy
Spectranetics Corporation
Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
| Date | Aug 9, 2010 (initiated Jul 1, 2010) |
| Status | Terminated |
| Reason | Guidewire lumen may be occluded, preventing guidewire insertion into the catheter. |
| Root cause | Process control |
| Action | Consignees were notified by letter on Jul 1, 2010, and told to not use affected lots and to contact Spectranetics to arrange a product exchange. More information is available at 800-231-0978. |
| Quantity | 5080 units (1778 US, 3302 Non-US) |
| Distribution | Worldwide distribution: USA, Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela. |
| FDA record | Open on fda.gov |