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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Kensey Nash Corp
Lot Codes / Batch Numbers
Part number 61000-01. Lot number 48275 exp 1/07
Products Sold
Part number 61000-01. Lot number 48275 exp 1/07
Kensey Nash Corp is recalling TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a proce due to Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarm. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026