FDA Medical Device Recalls (openFDA)
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 number
- Z-1219-06
- Recalling firm
- Kensey Nash Corp
- 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.
- Status
- Terminated
- Initiated
- 2006-05-24
- Posted
- 2006-07-12
- Terminated
- 2006-07-11
- Reason
- Volume control knob not able to go up to larger diameters
- Root cause
- Other
- Action
- 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.
- Quantity
- 10 kits
- Distribution
- Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
- Lot, serial or model codes
- Lot number 47303 exp 9/30/06
- 510(k) numbers
- ["K042040"]
- PMA numbers
- not on file
- Product code
- NFA
- Firm FEI
- 1000307073
- Firm city
- Exton
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28