Recall Z-1143-2020 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Abbott Vascular
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
| Date | Feb 14, 2020 (initiated Jan 29, 2020) |
| Status | Terminated |
| Reason | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Root 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 ai |
| Quantity | 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 |
| FDA record | Open on fda.gov |