Class 1 Device Recall NC TRAVLER Coronary Dilatation Catheter

• Date Initiated by Firm: January 29, 2020
• Date Posted: February 14, 2020
• Recall Status: Terminated on April 16, 2024
• Recall Number: Z-1144-2020
• Recall Event ID: 84826
• 510(K)Number: K103153 K110134
• Product Classification: Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
• Product: NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
• Code Information: Device Identifier/GTIN: 08717648196034 Part Number: 1013158-12 Lot Numbers:90813G1
• Recalling Firm/ Manufacturer: Abbott Vascular; 26531 Ynez Rd; D-03Q3, AP52-1; Temecula CA 92591-4630
• For Additional Information Contact: Alicia Swanson; 408-845-3427
• Manufacturer Reason for Recall: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
• FDA Determined Cause: Process change control
• Action: On 01/29/2020, the firm field personnel and Affiliates directly contacted the first customers beyond the firm's control via phone, email, or personal visit to facilitate rapid notification. The "URGENT MEDICAL DEVICE RECALL" Notification informed customers that specific lots of its Coronary Dilatation Catheters with diameters of 4.0 mm, 4.5 mm, and 5.0 mm may exhibit difficulty or inability to deflate the balloon due to weaker material proximal to the balloon bond resulting from excess heat exposure during manufacturing, and the potential risks with the use of the affected products include air embolism, thrombosis, myocardial infarction and additional intervention. Healthcare Professionals will be instructed to: " Reference the attached list of affected part numbers and lot numbers " Immediately stop using affected devices from these lots " Review your inventory, complete and return the attached Effectiveness Check Form " Return all unused affected product to Abbott " Share this notification with other relevant personnel in their organization The action the Recalling Firm is taking: * Stopped shipping affected lots * Will implement appropriate corrective actions to ensure product performance * Field Representatives can assist in identifying and returning affected devices * Will work with customers to replace returned units with similar devices, pending availability. For any questions, contact Customer Service Department at (800) 227-9902.
• Quantity in Commerce: Total 791 Traveler (0 US and 791 OUS)
• Distribution: Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam
• 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