Device recall
Z-0439-2023: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF…
FDA device recall · Class I · ARROW INTERNATIONAL Inc.
Key facts
| Recall number (Z-number) | Z-0439-2023 |
|---|---|
| Recall event | 91021 |
| Product | Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump |
| Product code | DSP |
| Recalling firm | ARROW INTERNATIONAL Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K201112 |
| FEI number | 3013162291 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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