Device recall
Z-1374-2019: SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425…
FDA device recall · Class I · Terumo Medical Corporation
Key facts
| Recall number (Z-number) | Z-1374-2019 |
|---|---|
| Recall event | 82705 |
| Product | SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath Re-Collapsible Access… |
| Product code | DYB |
| Recalling firm | Terumo Medical Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 22, 2020 |
| 510(k) numbers | K100819 |
| FEI number | 1118880 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database