Device recall
Z-1950-2020: TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product…
FDA device recall · Class II · Cardiac Assist, Inc
Key facts
| Recall number (Z-number) | Z-1950-2020 |
|---|---|
| Recall event | 85322 |
| Product | TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system. |
| Product code | KFM |
| Recalling firm | Cardiac Assist, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2020 |
| 510(k) numbers | K110493 |
| FEI number | 3002228812 |
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