Recall Z-1305-06 ยท NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Kensey Nash Corp
TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.
| Date | Jul 28, 2006 (initiated Apr 6, 2006) |
| Status | Terminated |
| Reason | Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting |
| Root cause | Other |
| Action | The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers. |
| Quantity | 69 kits |
| Distribution | The product was shipped to hospitals in Germany and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.