Merge Hemo 10.3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842000100874), received between Jul 15, 2021 and Jul 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Measurement” (1 report).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K152864); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jul 23, 2021Terminated

   The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.

   Z-2387-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2021Incorrect Measurement; Incorrect Measurement

  MERGE HEMO DISPLAYS, MEASURES, AND RECORDS PHYSIOLOGICAL DATA FROM A PATIENT UNDERGOING A CARDIAC CATHETERIZATION PROCEDURE. THE HEMO SYSTEM CAN VISUALIZE AND CAPTURE VITAL SIGN VALUES INCLUDING ECG, IMPEDANCE RESPIRATION, SPO2 AND PLETH WAVEFORMS, INVASIVE BLOOD PRESSURE, TEMPERATURE, NON-INVASIVE BLOOD PRESSURE (NIBP), THERMODILUTION CARDIAC OUTPUT AND FRACTIONAL FLOW RESERVE (FFR). THE SYSTEM CAN DISPLAY AND CAPTURE DIAGNOSTIC QUALITY 12 LEAD RESTING ECG TO VISUALIZE ARRHYTHMIAS, AND ST-SEGMENT CHANGES. SOME HEMO SYSTEMS HAVE AN OPTION TO MEASURE AND DISPLAY SIDE-STREAM END TIDAL CARBON DIOXIDE (ETCO2) ALONG WITH APNEA AND RESPIRATION RATES CALCULATED FROM THE ETCO2 WAVEFORM. THE HEMODYNAMIC PORTION OF THE SYSTEM IS COMPRISED OF THE PATIENT DATA MODULE (PDM) AND THE MERGE HEMO MONITOR PC. THE TWO UNITS ARE CONNECTED VIA A SERIAL INTERFACE. ALL VITAL PARAMETERS ARE ACQUIRED AND CALCULATED IN THE PDM. THIS DATA IS THEN TRANSMITTED TO THE MERGE HEMO MONITOR PC VIA THE SERIAL INTERFACE. ALL DATA CAN THEN BE DISPLAYED ON THE MERGE HEMO MONITOR PC. THE MERGE HEMO SYSTEM IS NOT INTENDED TO PRODUCE ALARMS FOR OUT-OF-RANGE CONDITIONS. PATIENT ALLERGIES AND CURRENT MEDICATION INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178358 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152864. One submission often covers many models, so check the product and lot details in each record.

• Z-0350-2018 · Apr 6, 2017 · Terminated
  Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo Syste