Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Recommended Action

Per FDA guidance

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.