Device recall
Z-1303-2014: FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm…
FDA device recall · Class II · Medtronic Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-1303-2014 |
|---|---|
| Recall event | 67646 |
| Product | FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is indicated for use as a… |
| Product code | NTE |
| Recalling firm | Medtronic Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2014 |
| 510(k) numbers | K082348 |
| FEI number | 3001452571 |
At a glance
- 1–9 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