Z-0306-05

EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''

Name: Z-0306-05 EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''
Creator: Edwards Lifesciences Research Medical Inc
Published: 2004-11-19
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2004-11-19 / Terminated

FDA source

Edwards Lifesciences Research Medical Inc began a recall of EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11'' on 2004-11-19. The reason FDA records is "Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0306-05
Status: Terminated
Initiated: 2004-11-19
Posted: 2004-12-15
Terminated: 2005-01-07
Recalling firm: Edwards Lifesciences LLC
Product: EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.
FDA root cause: Other
Action: All consignees were notified by letter on 11/22/2004
Quantity in commerce: 396 units
Distribution: AL, CA, CO, FL, GA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OR, PA, RI, TN, TX, VA, WA, and WI. No foreign, military or government distribution.
Product codes and lots: Model EX24D, Lot No.: 58174875

Product code DWF

K020693Class IIAortic Cannula, Metal J-Tip (24Fr) Model #Cf00100; Aortic Cannula, Plastic J-Tip (24Fr) Model #Cf00101Embol-X, Inc. / cleared 2002-09-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)