Class I — Medtronic Inc
| Recalling firm | Medtronic, Inc. |
|---|---|
| Registered facility | View this company's 53 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. |
| Product | 6F Taiga Guiding Catheter |
| Quantity | 15,923 |
| Distribution | Japan |
| Initiated | 2017-09-26 |
| Classified | 2018-03-29 |
| Terminated | 2021-04-27 |
| Recall number | Z-1207-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Medtronic Inc (Z-1207-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79449/
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