Recall Z-1136-2020 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Abbott Vascular
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patie
| 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 39687 NC TREK units (13891 US and 25796 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 |