Recall Z-1207-2018 ยท DQY Catheter, Percutaneous
Medtronic Inc
6F Taiga Guiding Catheter
| Date | Mar 29, 2018 (initiated Sep 26, 2017) |
| Status | Terminated |
| Reason | Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. |
| Root cause | Nonconforming Material/Component |
| Action | A recall notification was sent to all costumers in September 2017. Customers actions to be done: Identify and quarantine all unused affected products as listed in your inventory. Share notification with others who need to be aware where affected product may have potentially been transferred. |
| Quantity | 15,923 |
| Distribution | Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083422 | 6F TAIGA GUIDING CATHETER Medtronic Vascular, Feb 6, 2009 |