Z-0085-2010

EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R...

Name: Z-0085-2010 EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R...
Creator: Edwards Lifesciences Research Medical, Inc.
Published: 2009-09-24
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2009-09-24 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences Research Medical, Inc. began a recall of EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards Lifesciences LLC Irvine, CA... on 2009-09-24. The reason FDA records is "Spontaneous balloon rupture during use of the product". 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-0085-2010
Status: Terminated
Initiated: 2009-09-24
Posted: 2009-11-06
Terminated: 2012-04-25
Recalling firm: Edwards Lifesciences LLC
Product: EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards Lifesciences LLC Irvine, CA 92614-5686" The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta. Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
Product code: DXC Clamp, Vascular
Reason for recall: Spontaneous balloon rupture during use of the product.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were notified by an Urgent - Product Recall letter, dated 9/29/09, and instructed to check their inventory, identify any unused product and return it to the company. Customers are to contact Customer Service Organization at 1-800-424-3278 to obtain a Returned Goods Authorization number, information concerning replacement product, and if they have any questions.
Quantity in commerce: 2,737 total
Distribution: Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand.
Product codes and lots: Model EC65 (codes are recorded in the following format: Lot #/Expiration date): 610810/Feb-10; 638667/Jun-10; 643626/Jun-10; and 651863/Aug-10.

Product code DXC

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)