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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 Heartportsee related information
Date Initiated by FirmOctober 02, 2003
Date PostedJanuary 09, 2004
Recall Status1 Terminated 3 on October 19, 2005
Recall NumberZ-0307-04
Recall Event ID 27410
510(K)NumberK955121 K971291 K972570 K974736 K990772 K994253 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
ProductEndoReturn 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, 21 Fr. Product code ER21 (07043). The cannulas are also packaged in kits that have no specific lot number. The EndoReturn arterial cannula is packaged in the ''EndoCPB (Cardiopulmonary Bypass) System with Cardioplegia Catheter, Product codes ECPB211, 212, 213, 214, 231, 232. Also, the EndoCPB system without Cardioplegia Catheter, Product codes ECPB211, 212, 231, 232.
Code Information Lot Numbers 020349, 050327, 060337.
FEI Number 3000719637
Recalling Firm/
Manufacturer		 Heartport Inc
Route 22 West
Somerville NJ 08876
For Additional Information ContactWilliam Goeller
908-218-2651
Manufacturer Reason
for Recall		Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
FDA Determined
Cause 2		Other
ActionRecall 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 Commerce376 units
DistributionProducts 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 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
510(K)s with Product Code = DWF
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