Device recall
Z-2522-2018: CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient…
FDA device recall · Class II · Abbott Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-2522-2018 |
|---|---|
| Recall event | 80230 |
| Product | CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000 |
| Product code | MOM |
| Recalling firm | Abbott Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 2021 |
| PMA numbers | P100045 |
| FEI number | 3004936110 |
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