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.
FDA Recall Z-1305-06 · Posted 2006-07-28
Recalling FirmKensey Nash Corp
Recall StatusTerminated
Product CodeNFA
Date Initiated2006-04-06
Date Terminated2006-08-10
Product Quantity69 kits
Reason for Recall
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
Firm Action
The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers.
Root Cause
Other
Distribution Pattern
The product was shipped to hospitals in Germany and Italy.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.