Device recall
Z-0940-2011: Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet…
FDA device recall · Class I · Maquet Cardiovascular, LLC
Key facts
| Recall number (Z-number) | Z-0940-2011 |
|---|---|
| Recall event | 56868 |
| Product | Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic… |
| Product code | DXC |
| Recalling firm | Maquet Cardiovascular, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 21, 2011 |
| 510(k) numbers | K022880 |
| FEI number | 2242352 |
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