Device recall
Z-1931-2009: iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System…
FDA device recall · Class II · Abiomed, Inc.
Key facts
| Recall number (Z-number) | Z-1931-2009 |
|---|---|
| Recall event | 52200 |
| Product | iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic… |
| Product code | DSQ |
| Recalling firm | Abiomed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 5, 2014 |
| PMA numbers | P900023 |
| FEI number | 1220648 |
At a glance
- None 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