Device recall
Z-1115-03: Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm…
FDA device recall · Class II · Boston Scientific Scimed
Key facts
| Recall number (Z-number) | Z-1115-03 |
|---|---|
| Recall event | 26708 |
| Product | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-4015 , Product Number H7493791540150 |
| Product code | GBR |
| Recalling firm | Boston Scientific Scimed |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 28, 2006 |
| 510(k) numbers | K021735 |
| FEI number | 3002095335 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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