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U.S. Department of Health and Human Services

Class 3 Device Recall Heartport

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  Class 3 Device Recall Heartport see related information
Date Initiated by Firm October 02, 2003
Date Posted January 09, 2004
Recall Status1 Terminated 3 on October 19, 2005
Recall Number Z-0308-04
Recall Event ID 27410
510(K)Number K955121  K971291  K972570  K974736  K990772  K994253  
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 23 Fr. Product code ER23 (07044).
Code Information Lot Numbers 020347, 030343, 060338, 080348
Recalling Firm/
Heartport Inc
Route 22 West
Somerville NJ 08876
For Additional Information Contact William Goeller
Manufacturer Reason
for Recall
Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
FDA Determined
Cause 2
Action Recall was first initiated on/about 10/2/03 by phone domestically from the Director of Marketing to the firm''s Sales Force (no phone script available). Following the initial phone call, formal recall letters were sent out on 10/6/03 to: Director of CV Suite; Director of the OR; and Director of Material Management of each hospital.
Quantity in Commerce 209 units
Distribution Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
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.
510(K)s with Product Code = DWF and Original Applicant = MERIT MEDICAL SYSTEMS, INC.