Device recall
Z-3021-2018: CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part…
FDA device recall · Class II · Cardiovascular Systems Inc
Key facts
| Recall number (Z-number) | Z-3021-2018 |
|---|---|
| Recall event | 80765 |
| Product | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication independent from that of the… |
| Product code | MCX |
| Recalling firm | Cardiovascular Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2019 |
| PMA numbers | P130005 |
| FEI number | 3004742232 |
At a glance
- None 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