Class 1 Device Recall NC Trek RX Coronary Dilatation Catheter

• Date Initiated by Firm: March 22, 2017
• Date Posted: May 12, 2017
• Recall Status: Terminated on February 07, 2018
• Recall Number: Z-2039-2017
• Recall Event ID: 76841
• 510(K)Number: K103153
• Product Classification: Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
• Product: NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
• Code Information: Lot Number 60202G1 60301G1 60502G1 60301G1 60401G1 61101G1 60202G1 60401G1 60601G1 60801G1 61101G1 60302G1 60401G1 60601G1 60801G1 60202G1 60401G1 60502G1 60601G1 60701G1 60902G1 61004G1 61101G1 60202G1 60301G1 60401G1 60502G1 60601G1 60701G1 60801G1 60902G1 61101G1 60401G1 60601G1 60801G1 60301G1 60701G1 60301G1 60502G1 60701G1 60301G1 60502G1 60701G1 60902G1 60301G1 60502G1 60701G1 61004G1 60301G1 60401G1 60601G1 60701G1 60805G1 61004G1 50204G1 50406G1 50202G1 50901G1 50204G1 60202G1 60502G1 60701G1 61101G1 60202G1 60506G1
• 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: 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