FDA Medical Device Recalls (openFDA)
Kensey Nash Corp: TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.
- Recall number
- Z-0833-2007
- Recalling firm
- Kensey Nash Corp
- Product
- TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.
- Status
- Terminated
- Initiated
- 2007-03-28
- Posted
- 2007-05-31
- Terminated
- 2007-08-30
- Reason
- Insufficient wire sealing
- Root cause
- Other
- Action
- On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted.
- Quantity
- 427 kits
- Distribution
- Worldwide, including USA and Germany.
- Lot, serial or model codes
- Catalog numbers 60040-02 and 60040-03. Lot numbers 49709 exp 3/31/07, 51844 exp 5/31/07, 52822 exp 7/31/07, 53209 exp 5/31/07, 53252 exp 7/31/07, 54264 exp 7/31/07, 54276 exp 11/30/07, 49912 exp 3/30/07, 50952 exp 5/31/07, 51714 exp 7/31/07, 52488 exp 5/31/07, and 54248 exp 11/30/07.
- 510(k) numbers
- ["K061772"]
- PMA numbers
- not on file
- Product code
- FRO
- 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