Device recall
Z-1815-2008: ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF…
FDA device recall · Class III · Ev3, Inc
Key facts
| Recall number (Z-number) | Z-1815-2008 |
|---|---|
| Recall event | 48098 |
| Product | ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which balloon angioplasty has been applied. The IntaCoil stent is indicated for placement in flexing regions and… |
| Product code | NIP |
| Recalling firm | Ev3, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 10, 2011 |
| PMA numbers | P000033 |
| FEI number | 2183870 |
At a glance
- None Linked 510(k)s
- 1–9 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