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U.S. Department of Health and Human Services

Class 1 Device Recall NC Trek RX Coronary Dilatation Catheter

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  Class 1 Device Recall NC Trek RX Coronary Dilatation Catheter see related information
Date Initiated by Firm March 22, 2017
Date Posted May 12, 2017
Recall Status1 Terminated 3 on February 07, 2018
Recall Number Z-2038-2017
Recall Event ID 76841
510(K)Number K103153  
Product Classification Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
Product NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12
1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15
Code Information Lot Number 61209G1 61209G2 61102G1 61102G1 61012G1 61209G1 61101G1 60415G1 61209G1 61102G1 61101G1 61101G1 61102G1 60415G1 61102G1 61101G1 60415G1 61209G1 61102G1 50415G1 50919G1 51110G1 61209G1 50919G1 51210G1 61101G1 61102G1 60415G1 61102G1 60415G1 61209G1 
Recalling Firm/
Manufacturer		 Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact
951-914-2400
Manufacturer Reason
for Recall		 Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
FDA Determined
Cause 2		 Device Design
Action An Urgent Field Safety Notice dated 3/22/17 was sent to customers to inform them that Abbott Vascular is recalling the NC Trek RX Coronary Dilation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PCTA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. The letter informs the customers of how does the issue occur and what action is Abbott Vascular asking the customers to take. Customers with any questions are instructed to contact local Abbott Vascular Representative or Customer Service Department at (800) 227-9902. On 5/15/17, Abbott Vascular posted a press release on their website to inform customers that Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction.
Quantity in Commerce 449,661 units total (132,040 units in US)
Distribution US and Worldwide
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 = LOX and Original Applicant = ABBOTT VASCULAR-CARDIAC THERAPIES
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