Edwards Lifesciences Research Medical Inc EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.
Brand
Edwards Lifesciences Research Medical Inc
Lot Codes / Batch Numbers
Model EX24D, Lot No.: 58174875
Products Sold
Model EX24D, Lot No.: 58174875
Edwards Lifesciences Research Medical Inc is recalling EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''. due to Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.
Recommended Action
Per FDA guidance
All consignees were notified by letter on 11/22/2004
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, FL, GA, IL, MD, MA, MI, MN, MO, NV, NJ, NM, NY, NC, OR, PA, RI, TN, TX, VA, WA, WI
Page updated: Jan 10, 2026