Kensey Nash Corp TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using the standard femoral approach. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using the standard femoral approach.
Brand
Kensey Nash Corp
Lot Codes / Batch Numbers
Lot number 47303 exp 9/30/06
Products Sold
Lot number 47303 exp 9/30/06
Kensey Nash Corp is recalling TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protec due to Volume control knob not able to go up to larger diameters. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Volume control knob not able to go up to larger diameters
Recommended Action
Per FDA guidance
A letter was issued to the sales representative that have customers which received affected product, 5/24/2006. Sales representatives visited their sites within 3 days to determine if the affected product was still in inventory. If the product was still in inventory the sales representative provided the trained TriActiv System user(s) a Technical Bulletin that instructed the users how to correct the knob position.
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 noticePage updated: Jan 10, 2026