Z-0134-2014Class II

Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only...

Name: Z-0134-2014 Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only...
Creator: Edwards Lifesciences, LLC
Published: 2013-08-26
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-08-26 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards... on 2013-08-26. FDA classified it as Class II and gives the reason as "Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0134-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-26
Posted: 2013-11-01
Terminated: 2017-02-22
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Edwards sent an Urgent Field Safety Notice Product Recall letter dated August 26, 2013 to all affected customer, via Fed-Ex. The product is sold directly to hospitals and distributors. The distributors involved will communicate with their customers directly. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their entire inventory, quarantine and return the affected products. An acknowledgement form is included for completion to assist in the assessment of the inventory. For questions contact Edwards Customer Service at 800-424-3278.
Quantity in commerce: 80 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot number 59388992 expiry 1/1/16

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0134-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0134-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-01
Z-0135-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-01

Product code DWF

K123370Class IIEz Glide Aortic Cannula, Aortic Perfusion Cannula with Duraflo Coating, Dispersion Aortic Perfusion CannulaEdwards Lifesciences, LLC / cleared 2013-03-13

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)