6F Taiga Guiding Catheter
FDA device recall Z-1207-2018 · posted 2018-03-29 · Terminated
Recall details
- Recalling firm
- Medtronic Inc
- Reason for recall
- Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 15,923
- Distribution
- Japan
- Date initiated
- 2017-09-26
- Date posted
- 2018-03-29
- Date terminated
- 2021-04-27
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6F TAIGA GUIDING CATHETER (K083422) | Medtronic Vascular | 2009-02-06 |