Recall Z-3253-2018 ยท DQO Catheter, Intravascular, Diagnostic
Medtronic Vascular
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
| Date | Aug 16, 2018 |
| Status | Terminated |
| Reason | Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct. |
| Root cause | Error in labeling |
| Action | Medtronic initiated consignee communications on 16-Aug-2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic. |
| Quantity | 250 units |
| Distribution | CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak Medtronic Vascular, Aug 19, 2016 |