Drug recall
CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b)…
FDA recall event 80230 · Class II · Abbott Laboratories, Inc.
Key facts
| Event ID | 80230 |
|---|---|
| Recall numbers | Z-2522-2018 |
| Recalling firm | Abbott Laboratories, Inc. |
| Product type | Devices |
| Products | CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems (Model CM1100) may deliver a system error, known as Error… |
| Initiation date | Jun 14, 2018 |
| Report date | Aug 1, 2018 |
| Termination date | Sep 8, 2021 |
| City | Atlanta |
| State | GA |
| Country | United States |
| FEI number | 3004936110 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: