Z-0833-2007

TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has...

Name: Z-0833-2007 TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has...
Creator: Kensey Nash Corp
Published: 2007-03-28
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2007-03-28 / Terminated

FDA source

Kensey Nash Corp began a recall of 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... on 2007-03-28. The reason FDA records is "Insufficient wire sealing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0833-2007
Status: Terminated
Initiated: 2007-03-28
Posted: 2007-05-31
Terminated: 2007-08-30
Recalling firm: DSM Biomedical, Inc.
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.
Product code: FRO Dressing, Wound, Drug
Reason for recall: Insufficient wire sealing
FDA 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 in commerce: 427 kits
Distribution: Worldwide, including USA and Germany.
Product codes and lots: 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.

Product code FRO

K061772Class IITriactiv Fx Embolic Protection SystemKensey Nash Corp. / cleared 2006-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)