Z-1305-06

TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit...

Name: Z-1305-06 TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit...
Creator: Kensey Nash Corp
Published: 2006-04-06
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2006-04-06 / Terminated / root cause: software

FDA source

Kensey Nash Corp began a recall of 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... on 2006-04-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1305-06
Status: Terminated
Initiated: 2006-04-06
Posted: 2006-07-28
Terminated: 2006-08-10
Recalling firm: DSM Biomedical, Inc.
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.
Product code: NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Reason for recall: 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
Root cause tag: software
FDA root cause: Other
Action: The recalling firm issued a draft recall letter to their European distributor who translated the letter for their customers.
Quantity in commerce: 69 kits
Distribution: The product was shipped to hospitals in Germany and Italy.
Product codes and lots: Part number 61000-01. Lot number 48275 exp 1/07

Product code NFA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)