Device recall
Z-0621-2009: Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0621-2009 |
|---|---|
| Recall event | 50487 |
| Product | Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland: Interventional Technologies Europe Ltd., A subsidiary of Boston Scientific Letterkenny, County Donegal, Republic of… |
| Product code | LOX |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2011 |
| PMA numbers | P950020 |
| FEI number | 3002095335 |
At a glance
- None 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