Device recall
Z-2298-2025: Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit…
FDA device recall · Class II · Insightra Medical Inc
Key facts
| Recall number (Z-number) | Z-2298-2025 |
|---|---|
| Recall event | 97246 |
| Product | Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30… |
| Product code | DSP |
| Recalling firm | Insightra Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2026 |
| 510(k) numbers | K082746 |
| FEI number | 3003945344 |
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