Z-1963-2013Class II

Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512...

Name: Z-1963-2013 Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512...
Creator: Edwards Lifesciences, LLC
Published: 2013-07-30
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-07-30 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo... on 2013-07-30. FDA classified it as Class II and gives the reason as "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". 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-1963-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-08-14
Terminated: 2014-10-14
Recalling firm: Edwards Lifesciences LLC
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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1963-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1963-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-14

Product code DWF

K990396Class IIT-AnastafloEdwards Lifesciences Research Medical / cleared 1999-10-01

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)