Class 2 Device Recall Anastaflo Intravascular Shunt

• Date Initiated by Firm: July 30, 2013
• Date Posted: August 14, 2013
• Recall Status: Terminated on October 14, 2014
• Recall Number: Z-1963-2013
• Recall Event ID: 65838
• 510(K)Number: K990396
• Product Classification: Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
• Product: Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25; ; Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30.
• Code Information: Model: IVS12512 Lots 58969460 to 59509355, Model: IVS1512 Lots 58914820 to 59518788, Model: IVS1530 Lots 58911395 to 59473506, Model: IVS17512 Lots 58903206 to 59546227, Model: IVS2012 Lots 58911394 to 59531271, Model: IVS2030 Lots 58932183 to 59504235, Model: IVS2512 Lots 58914819 to 59518801, Model: IVS2530 Lots 58919317 to 59463362, Model: IVS3012 Lots 58966707 to 59514116
• Recalling Firm/ Manufacturer: Edwards Lifesciences, LLC; 12050 Lone Peak Pkwy; Draper UT 84020-9414
• For Additional Information Contact: Suzanne Carpenter; 801-565-6195
• Manufacturer Reason for Recall: Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts.
• FDA Determined Cause: Process control
• Action: Edwards Lifesciences sent a Urgent Field Safety Notice letter dated July 30, 2013, via Fed-Ex to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters are tracked through customer service and as part of the customer acknowledgement letter. Customers are asked to return products. If the customer does not send back the acknowledgement letter, three additional contacts are made to notify the customer and request return of affected product. This is tracked by Edwards customer service and reported each week. We reconcile the shipments made to customers against the returned product to determine impact to distribution. Once you have verified your inventory, please complete the attached acknowledgment form and fax it back to Edwards Customer Service at 800.422.9329 within three days of receipt of this Field Safety Notice. The return of this form allows us to confirm that you have reviewed this notice and have taken appropriate action. Please contact Customer Service at 800.424.3278 to obtain a Returned Goods Authorization number and replacement product. We sincerely regret the inconvenience caused by this action and appreciate your immediate attention to this matter. The Customer Service organization can answer questions about when replacement IVS Shunts will be available. If you have questions that have not been answered by this letter, please call Edwards Customer Service at 800.424.3278 from the hours of 6:00AM - 4:30PM PST or contact your Edwards sales representative concerning the recall.
• Quantity in Commerce: 29,618 units
• Distribution: Nationwide and the country of Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWF and Original Applicant = EDWARDS LIFESCIENCES RESEARCH MEDICAL