Merge HemoRecalls & reported problems across all models

Merge Healthcare Solutions Inc. · 5 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 33
Deaths reported: 0
Injuries reported: 0
Recalls: 1

We found 5 models of Merge Hemo by Merge Healthcare Solutions Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between May 14, 2018 and Dec 26, 2024 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (11 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Last 36 months. The most recent month may be incomplete.

Merge Hemo recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 3 of these models · Recall details · FDA record ↗

Most reported Merge Hemo problems

Device problems

Computer Software Problem11
Improper or Incorrect Procedure or Method11
Incorrect, Inadequate or Imprecise Result or Readings10
No Apparent Adverse Event10
Communication or Transmission Problem6
No Device Output4
Power Problem4
Output Problem3

Patient problems

No Clinical Signs, Symptoms or Conditions19
No Known Impact Or Consequence To Patient15
No Consequences Or Impact To Patient2
No Patient Involvement1

Merge Hemo models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

Merge Hemo 10.4
Computer, Diagnostic, Programmable
1 recall14 reports
Merge Hemo 10.2
Computer, Diagnostic, Programmable
1 recall3 reports
Merge Hemo 10.3
Computer, Diagnostic, Programmable
1 recall1 report
Merge Hemo 10.0.4
Computer, Diagnostic, Programmable
11 reports
Merge HEMO 10.1
Computer, Diagnostic, Programmable
4 reports

Recent Merge Hemo adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

MalfunctionDec 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
ON (B)(6) 2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED: HEART RATE REPORTING AS 4 BEAT PER MINUTE (BPM), ACTUAL HEART RATE 70 BPM. MERGE HEALTHCARE HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER FOR THIS EVENT. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21021139 ↗
MalfunctionSep 25, 2024Computer Software Problem; Application Program Problem; Computer Software Problem; Application Program Problem
ON 08/29/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED THAT THE CLIENT/DOCUMENTATION SIDE OF THE DEVICE HAD A SPINNING WHEEL ON THE SCREEN DURING A ST SEGMENT ELEVATION MYOCARDIAL INFARCTION PROCEDURE. MERGE HEMO CONTINUED TO DISPLAY AND UPDATE THE PATIENT'S VITAL SIGNS. THE USER, A REGISTERED NURSE, WAITED APPROXIMATELY FOUR MINUTES AND THEN REBOOTED THE CLIENT/DOCUMENTATION PC SO THAT DOCUMENTING THE PROCEDURE COULD CONTINUE. MERGE HEALTHCARE HAS INVESTIGATED THE ISSUE, BASED ON WHAT THE CUSTOMER PROVIDED IN THE MEDSUN REPORT. IT APPEARS THAT THE SPINNING WHEEL ISSUE PROBABLY OCCURRED DUE TO A SOFTWARE DEFECT. MERGE HEALTHCARE IS WORKING WITH THE CUSTOMER TO PROVIDE A SOFTWARE UPDATE. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20300213 ↗
MalfunctionSep 25, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
ON 08/29/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED NO VALUE FOR HEART RATE DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. USER WAS ABLE TO GET AN ACCURATE HEART RATE AFTER CHANGING LEADS MULTIPLE TIMES. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20300207 ↗
MalfunctionSep 25, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
ON 08/29/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE MULTIPLE TIMES DURING A PERIPHERALLY INSERTED CENTRAL CATHETER MID-SEGMENT OF THE LEFT ANTERIOR DECENDING ARTERY PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20300194 ↗
MalfunctionSep 24, 2024Failure to Zero; Improper or Incorrect Procedure or Method; Pressure Problem; Failure to Zero; Improper or Incorrect Procedure or Method; Pressure Problem
ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED THAT A USER WAS UNABLE TO ZERO PRESSURES DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. ACCORDING TO THE CUSTOMER, THE PROCEDURE WAS DELAYED BY SEVEN MINUTES. MERGE HEALTHCARE HAS BEEN WORKING WITH THE CUSTOMER TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN CONFIRMED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297463 ↗
MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE DURING A PACEMAKER INSERTION PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8017
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297461 ↗
MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE DURING A CATH LAB PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297269 ↗
MalfunctionSep 24, 2024Computer Software Problem; Unintended Application Program Shut Down; Computer Software Problem; Unintended Application Program Shut Down
ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED THAT THE CLIENT/DOCUMENTATION SIDE OF THE DEVICE SHUT DOWN DURING A ST SEGMENT ELEVATION MYOCARDIAL INFARCTION PROCEDURE. THE PHYSICIAN WAS ABLE TO PROCEED WITH THE PROCEDURE AND CARE FOR THE PATIENT BECAUSE MERGE HEMO CONTINUED TO DISPLAY AND UPDATE THE PATIENT'S VITAL SIGNS THROUGHOUT THE PROCEDURE. THE CUSTOMER RELOGGED INTO THE MERGE HEMO CLIENT SO THAT DOCUMENTING COULD CONTINUE. MERGE HEALTHCARE HAS INVESTIGATED THE ISSUE AND DETERMINED THAT THIS ISSUE OCCURRED DUE TO A SOFTWARE DEFECT. MERGE HEALTHCARE IS WORKING WITH THE CUSTOMER TO PROVIDE A SOFTWARE UPDATE. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297252 ↗
MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE AND NO PULSE OXIMETER/SPO2 VALUE DURING A DUAL CHAMBER PACEMAKER PLACEMENT PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297230 ↗
MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE AND NO PULSE OXIMETER/SPO2 VALUE DURING AN IMPELLA PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297204 ↗
MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8020.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297203 ↗
MalfunctionSep 24, 2024Computer Operating System Problem; Computer Operating System Problem
ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE REPORTED THAT DURING PROCEDURE ROOM PREPARATION ACTIVITIES, THE MERGE HEMO DEVICE'S KEYBOARD AND MOUSE WERE UNRESPONSIVE. MERGE HEMO HAS TOUCHSCREENS AS ANOTHER INTERFACE OPTION BESIDES A KEYBOARD AND MOUSE. HOWEVER, DUE TO THE INABILITY TO USE A KEYBOARD AND MOUSE WITH MERGE HEMO, PATIENT PROCEDURES WERE PERFORMED IN OTHER LABS ONSITE. MERGE HEALTHCARE TECHNICAL SUPPORT REMOTELY CONNECTED TO THE AFFECTED SYSTEM AND CONFIRMED THAT THE CLIENT PC'S USB PORTS WERE NOT COMMUNICATING. A REPLACEMENT PC WAS SHIPPED OVERNIGHT AND A RETURN MATERIAL AUTHORIZATION (RMA) WAS INITIATED FOR THE DEFECTIVE PC. PER POLICY, EQUIPMENT RETURNED FROM CLIENTS IS WIPED PRIOR TO PERFORMING SYSTEM DIAGNOSTICS TO PROTECT PATIENT INFORMATION. AFTER WIPING THE DRIVE AND REINSTALLING THE OPERATING SYSTEM, DIAGNOSTIC TESTS WERE PERFORMED AND THE USB PORTS WERE FOUND TO BE FUNCTIONAL. HENCE, THE ROOT CAUSE OF THIS ISSUE IS UNKNOWN. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8014.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297199 ↗
MalfunctionSep 24, 2024Computer Software Problem; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER REPORTED THAT A USER WAS UNABLE TO SEND COMPLETED CARDIAC CATHETERIZATION PATIENT REPORTS TO THE EMR POST PROCEDURE. MERGE HEALTHCARE HAS INVESTIGATED THE ISSUE AND DETERMINED THAT THE INABILITY TO SEND REPORTS TO THE EMR WAS CAUSED BY A POLICY CHANGE WITHIN THE CUSTOMER'S ENVIRONMENT THAT AFFECTED FILE PERMISSIONS. WITHOUT THE APPROPRIATE FILE PERMISSIONS, PATIENT REPORTS CANNOT BE CREATED AND TRANSFERRED TO THE EMR. TO RESOLVE THE ISSUE, MERGE TECHNICAL SUPPORT RESTORED THE FILE PERMISSIONS WITHIN THE CUSTOMER'S ENVIRONMENT. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: 300360000-2024-8015.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20297158 ↗
MalfunctionSep 24, 2024Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
ON 08/26/2024, MERGE HEALTHCARE RECEIVED A COPY OF A MEDSUN REPORT. A MERGE HEMO CUSTOMER SITE ALLEGED THAT THE DEVICE DISPLAYED AN INACCURATE VALUE FOR HEART RATE AND BLANK OR ZERO SPO2 VALUES DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. MERGE HEALTHCARE HAS BEEN WORKING WITH THE SITE TO GATHER ADDITIONAL INFORMATION NECESSARY FOR AN EFFECTIVE ROOT CAUSE ANALYSIS. THE INVESTIGATION IS ONGOING, AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY OR HARM BECAUSE OF THIS ISSUE. REFERENCE: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20293279 ↗
MalfunctionAug 24, 2021No Device Output; No Device Output
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 12362826 ↗

Sources and updates

Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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