Data / Medical devices / United States / Abbott Medical
Abbott Medical: FDA-registered device maker in Atlanta, GA, United States, 1 PMA approval
Abbott Medical is registered with the FDA (registration 3004936110) in Atlanta, GA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated May 28, 2014. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004936110
- Address
- 387 Nerem St Nw Ste 500, Atlanta, GA, United States, 30313
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer
- First device listed
- February 12, 2018
- Registered through
- 2027
- Brand names listed
- CardioMEMS HERO Device, CardioMEMS HF System, CardioMEMS Hospital Electronics System, CardioMEMS Hospital System, CardioMEMS PA Sensor and Delivery System, CardioMEMS Patient Electronics System, Merlin.net Patient Care Network Heart Failure Portal
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Hemodynamic, Implantable | MOM | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 28, 2014 | P100045 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM | MOM | 90 | September 30, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 3, 2025 | 96326 | Class II | Ongoing | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model M | Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing. | accessdata.fda.gov |
| November 6, 2024 | 95706 | Class II | Ongoing | Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic dat | Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings. | accessdata.fda.gov |
| October 5, 2024 | 95602 | Class II | Ongoing | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF Syst | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings. | accessdata.fda.gov |
| October 4, 2023 | 93141 | Class II | Ongoing | CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate. | Potential for damaged and frayed power connector plug with repeated bending or manipulation beyond 90 degrees. | accessdata.fda.gov |
| February 7, 2023 | 91610 | Class II | Ongoing | CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. | Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000 exceed certain emissions limits and have the potential to cause interference with other medical devices, such as implantable neurostimulators, pacemakers, cardiac defibrilla | accessdata.fda.gov |
| February 7, 2023 | 91606 | Class II | Ongoing | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisition difficulties. | accessdata.fda.gov |
| June 14, 2018 | 80230 | Class II | Terminated | CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000 | 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 5. While this error message is intended to present if the electronics system exceeds a certain temperature, these units may deliver a false Error 5 message due | accessdata.fda.gov |
Compare with other makers
Updated September 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.