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Class 3 Device Recall Heartport |
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Date Initiated by Firm |
October 02, 2003 |
Date Posted |
January 09, 2004 |
Recall Status1 |
Terminated 3 on October 19, 2005 |
Recall Number |
Z-0311-04 |
Recall Event ID |
27410 |
510(K)Number |
K955121 K971291 K972570 K974736 K990772 K994253
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Product Classification |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
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Product |
Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042). |
Code Information |
Lot number 020374 |
Recalling Firm/ Manufacturer |
Heartport Inc Route 22 West Somerville NJ 08876
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For Additional Information Contact |
William Goeller 908-218-2651
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Manufacturer Reason for Recall |
Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
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FDA Determined Cause 2 |
Other |
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 |
13 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
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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.
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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.
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