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U.S. Department of Health and Human Services

Class 2 Device Recall Aortic cannula

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 Class 2 Device Recall Aortic cannulasee related information
Date Initiated by FirmNovember 19, 2004
Date PostedDecember 15, 2004
Recall Status1 Terminated 3 on January 07, 2005
Recall NumberZ-0306-05
Recall Event ID 30623
510(K)NumberK020693 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
ProductEMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.
Code Information Model EX24D, Lot No.: 58174875
FEI Number 1713910
Recalling Firm/
Manufacturer		 Edwards Lifesciences Research Medical Inc
6864 South 300 West
Midvale UT 84047-1083
For Additional Information Contact
801-565-6100
Manufacturer Reason
for Recall		Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.
FDA Determined
Cause 2		Other
ActionAll consignees were notified by letter on 11/22/2004
Quantity in Commerce396 units
DistributionAL, 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DWF
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