Device recall
Z-0889-2011: TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The…
FDA device recall · Class II · Cardiac Assist, Inc
Key facts
| Recall number (Z-number) | Z-0889-2011 |
|---|---|
| Recall event | 57414 |
| Product | TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when… |
| Product code | DWF |
| Recalling firm | Cardiac Assist, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 1, 2011 |
| 510(k) numbers | K052570 |
| FEI number | 3002228812 |
At a glance
- 1–9 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