Recall Z-1479-2018 ยท DQO Catheter, Intravascular, Diagnostic
Medtronic Vascular
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
| Date | Apr 20, 2018 (initiated Mar 13, 2018) |
| Status | Terminated |
| Reason | The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details. |
| Root cause | Packaging |
| Action | Medtronic initiated consignee communications on 13-Mar- 2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. OUS communications were sent per locally approved methods. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic. |
| Quantity | 855 units |
| Distribution | US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA, |
| 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 |