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Merlin.net MN6000Recalls & reported problems

Cardiomems, Inc. · HF Portal · Class 3 · Implant

4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
4

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

4 FDA recall records name this device's identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Feb 3, 2025Open, Classified

    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.

    Z-1427-2025 · Root cause: Software design · FDA record ↗

  2. Nov 6, 2024Open, Classified

    Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.

    Z-0987-2025 · Root cause: Under Investigation by firm · FDA record ↗

  3. Oct 5, 2024Open, Classified

    As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

    Z-0989-2025 · Root cause: Under Investigation by firm · FDA record ↗

  4. Oct 5, 2024Open, Classified

    As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.

    Z-0988-2025 · Root cause: Under Investigation by firm · FDA record ↗

Other Implantable pulse generator, pacemaker (non-CRT) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.