Device recall
Z-1517-2013: lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145…
FDA device recall · Class II · Invatec Llc
Key facts
| Recall number (Z-number) | Z-1517-2013 |
|---|---|
| Recall event | 65289 |
| Product | lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter… |
| Product code | DXE |
| Recalling firm | Invatec Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2013 |
| 510(k) numbers | K050276, K051917 |
| FEI number | 3006466080 |
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