Z-3077-2017Class II

Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806

Name: Z-3077-2017 Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806
Creator: Edwards Lifesciences, LLC
Published: 2017-07-06
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2017-07-06 / Terminated / root cause: packaging

FDA source

Edwards Lifesciences, LLC began a recall of Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot... on 2017-07-06. FDA classified it as Class II and gives the reason as "The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3077-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-06
Posted: 2017-08-26
Terminated: 2018-10-17
Recalling firm: Edwards Lifesciences LLC
Product: Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are designed to facilitate clots too resistant to be removed by an elastomeric balloon. The device features a spiral-shaped, latex-covered stainless steel cable that assumes a corkscrew shape when retracted, greatly expanding the surface areas to entrap fibrous material. The device is 80 cm in length and is available in 4F-6F diameters.
Product code: DXE Catheter, Embolectomy
Reason for recall: The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
Root cause tag: packaging
FDA root cause: Packaging
Action: Recall notification letters were sent to affected customers on 7/6/2017. The recall notice included a response form and instructed consignee to return any unused devices..
Quantity in commerce: 200 units
Distribution: Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI
Product codes and lots: Lots 60439817 and 60439818

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3077-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3077-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-08-25

Product code DXE

K901625Class IIFogarty Arterial Embolectomy II CatheterBaxter Healthcare Corp / cleared 1990-07-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)