Z-2196-2011

Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO...

Name: Z-2196-2011 Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO...
Creator: Edwards Lifesciences Llc
Published: 2011-01-21
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2011-01-21 / Terminated

FDA source

Edwards Lifesciences Llc began a recall of Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. The cannula... on 2011-01-21. The reason FDA records is "Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2196-2011
Status: Terminated
Initiated: 2011-01-21
Posted: 2011-05-13
Terminated: 2011-05-13
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. The cannula perfuses blood to the ascending aorta during short-term (<6 hours) cardiopulmonary bypass procedures. The device is a Duraflo coated cannula 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: Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation.
FDA root cause: Other
Action: The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated January 21, 2011 it customers via Fed-Ex. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory for any of the lot numbers; return all unused product from their stock to Edwards; contact their Customer Service Organization at (800) 424-3278 to obtain a Returned Goods Authorization number and replacement product; complete and return the Aortic Perfusion Cannula Recall Response form via fax to: Edwards at (949) 250-3489, and return unused product to Edwards Lifesciences, 12050 Lone Peak Drive, Draper, UT 84020. If you have questions that have not been answered by this letter, call Edwards Customer Service at (800) 424-3278 from 8:00AM - 4:30PM Pacific Time.
Quantity in commerce: 20
Distribution: Nationwide distribution: CA only.
Product codes and lots: Lot Number: 58946275

Product code DWF

K033463Class IIEdwards Lifesciences Research Medical Pediatric Arterial CannulaeEdwards Lifesciences, LLC / cleared 2004-07-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)