—#120408

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.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K990396
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 12050 Lone Peak Pkwy, Draper, Utah 84020-9414

Distribution

Distribution pattern: Nationwide and the country of Canada

Timeline

Recall initiated: 2013-07-30
Posted by FDA: 2013-08-14
Terminated: 2014-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.