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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards EndoReturn Arterial Cannula, model ER21B and ER23B

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  Class 2 Device Recall Edwards EndoReturn Arterial Cannula, model ER21B and ER23B see related information
Date Initiated by Firm July 16, 2013
Date Posted August 14, 2013
Recall Status1 Terminated 3 on November 30, 2016
Recall Number Z-1972-2013
Recall Event ID 65744
510(K)Number K971291  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Edwards EndoReturn Arterial Cannula, model ER21B and ER23B

Product Usage:
The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility, tapered tips to aid in insertion and advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in. (9.5 mm) barbed connector, and a hemostasis valve (available on some versions) that allows passage of catheters, such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions, a connector hub secures and immobilizes the introducer within the cannula for easier, one person insertion of the cannula/introducer assembly.
Code Information Model ER21B Lots: 59496984, 59516933, 59516936, 59531385, 59531386 , 59543708   Model ER23B Lots: 59464327, 59484349, 59484350, 59484351, 59512146, 59513272, 59516940, 59534430, 59535739, 59541763 
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
12050 Lone Peak Pkwy
Draper UT 84020-9414
For Additional Information Contact Suzanne Carpenter
801-565-6195
Manufacturer Reason
for Recall		 Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Edwards sent an Urgent Field Safety Notice letter dated July 16, 2013 via Fed-Ex. The letter identified the affected product, problem and action to be taken. The letter included a Customer Acknowledgement Form to be completed and faxed to 800-422-9329 Attn: Recall Coordinator. If the customer does not send back the acknowledgement form, two 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. Customer were requested to assess their inventory to assure that all affected product is identified and returned. Returned products will be destroyed. For questions call Edwards Customer Service at 800-424-3278.
Quantity in Commerce 855
Distribution US Nationwide including Canada and VA sites.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DWF and Original Applicant = HEARTPORT, INC.
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