—#98544

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.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K033463
Affected lot / code info: Lot Number: 58946275

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences Llc
Address: 12050 Lone Peak Parkway, Draper, Utah 84020-9414

Distribution

Distribution pattern: Nationwide distribution: CA only.

Timeline

Recall initiated: 2011-01-21
Posted by FDA: 2011-05-13
Terminated: 2011-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.