HysteroLux™ Fluid Management System Control Unit PH304Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04056702005672), received between Aug 13, 2019 and Jun 23, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K173489); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "IT WAS REPORTED THAT DURING A HYSTEROSCOPY WITH MYOMECTOMY PROCEDURE, ABOUT 75% OF THE WAY THROUGH RESECTING THE MYOMA, UTILIZING THE TRUCLEAR DENSE TISSUE PLUS, THE NURSE WENT TO HANG ANOTHER 3L BAG OF NORMAL SALINE AS INDICATED TO KEEP THE UTERUS DISTENDED. UPON SPIKING THE SALINE BAG, THE NURSE TWISTED THE SPIKE TUBING REPEATEDLY (INSTEAD OF ROCKING THE SPIKE BACK AND FOURTH). THIS CAUSED THE TUBING TO KINK AND AIR ENTERED THE INFLOW TUBE LINE OF THE HYSTEROLUX SYSTEM. THE NURSE THEN NEEDED TO UNTWIST THE BAG OF SALINE TO RELIEVE THE KINK, THEY REMOVED THE HANGING BAG OF SALINE FROM THE MACHINE TO GET IT UNKINKED, CREATING MORE AIR TO ENTER THE SYSTEM. IT WAS INDICATED TO THE SURGEON, THAT A BAG WAS BEING ADDED AND THAT IS WHY THEY LOST DISTENSION IN THE CAVITY. IT IS UNCLEAR FOR CERTAIN IF THE SURGEON PULLED THE SCOPE COMPLETELY OUT OF THE UTERUS, OR REMAINED IN THE ENDOCERVICAL CANAL AT THIS POINT IN THE PROCEDURE AS DISTENSION WAS LOST AND THEREFORE VISIBILITY DIMINISHED. AFTER THE NEW BAG OF SALINE WAS HUNG CORRECTLY THE PROCEDURE CONTINUED FOR ANOTHER 3-5 MINUTES, WHERE THE SURGEON WAS RESECTING THE MYOMA WITHOUT INCIDENT. THE

  Patient problems: Asystole

  MAUDE report 22305764 ↗
• MalfunctionApr 18, 2022Incorrect Measurement; Incorrect Measurement

  ACCORDING T THE REPORTER, THE UNIT HAD A DEFICIT CALCULATION MISREADING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14134961 ↗
• MalfunctionApr 6, 2021Output Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "ACCORDING TO THE REPORTER, DURING HYSTEROSCOPIC MYOMECTOMY - REMOVAL OF FIBROID, THE DEFICIT WAS CLIMBING PER USUAL. WHEN CHANGED A BAG, THE UNIT SIGNIFIED BAG CHANGE AND THE DEFICIT WENT FROM +600ML TO -900ML. MANUALLY TRACK AND COUNT THE DEFICIT TO ENSURE NO FLUID OVERLOAD ISSUED WOULD OCCUR. THERE WAS NO PATIENT INJURY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618247 ↗
• MalfunctionOct 1, 2020Incorrect Measurement

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "EVENT DESCRIPTION: ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPIC MYOMECTOMY, WHILE RESECTING THE MYOMA, THE UNIT'S FLUID OUTFLOW COUNT STOPPED AT 32,540 AND WHEN IT STOPPED COUNTING OUTFLOW, THE DEFICIT BEGAN TO SUBTRACT FROM 1500. THE SURGEON WAS INFORMED, AND THE STAFF DID A MANUAL COUNT TO ENSURE ACCURATE DEFICIT WAS STILL 1500 CC. THERE WAS NO PATIENT INJURY." "FLUID OUTFLOW COUNT STOPPED AT 32540 AND ONCE IT STOPPED COUNT-ING OUTFLOW, THE DEFICIT BEGAN TO SUBTRACT FROM 1500. SURGEON WAS INFORMED AND STAFF DID A MANUAL COUNT TO ENSURE ACCURATE DEFICIT WAS STILL 1500CCS. HYSTEROLUX MACHINE FUNCTIONED PERFECTLY UNTIL IT STOPPED COUNTING OUTFLOW AT 32540. THEN DEFICIT BEGAN TO SUBTRACT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10611853 ↗
• MalfunctionOct 1, 2020Application Program Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "I WAS IN A MYOMECTOMY CASE THAT WAS TAKING QUITE A LONG TIME. WE HAD BEEN RESECTING FOR ABOUT AN HOUR AND I WAS KEEPING A CLOSE WATCH ON THE DEFICIT AND THE TOTAL VOLUME USED. THEN ALL OF A SUDDEN, THE DEFICIT STARTED DROPPING FROM ABOUT 1300ML ALL THE WAY DOWN TO 0. AND THE TOTAL INFLOW VOLUME USED FROZE AT 32,450 ML EVEN THOUGH THE PUMP WAS STILL RUNNING AND FLUID WAS BEING USED. I WATCHED THE MACHINE FOR A SECOND AND THE DEFICIT FROZE AT 0ML AND THE TOTAL INFLOW REMAINED FROZEN AT 32,450ML. NO 'SCALE MALFUNCTIONS' ALERTS CAME ON THE SCREEN. EVERYTHING APPEARED TO BE FINE, EXCEPT THE ABILITY FOR THE PUMP TO CALCULATE THE FLUID AND THE DEFICIT. HOWEVER WE WERE WORKING FOR OVER AN HOUR AND HAD CHANGED BAGS AND CANISTERS OVER A DOZEN TIMES. WE DID A MANUAL DEFICIT COUNT, AND DEFICIT WAS WELL UNDER THE MAXIMUM RECOMMENDED AMOUNT HOWEVER, WE DECIDED TO ABORT THE PROCEDURE FOR PATIENT SAFETY CONCERNS, SEEING AS THE MACHINE COULD NO LONGER CALCULATE THE DEFICIT. THE HYSTEROLUX FLUID MANAGEMENT PUMP WORKED PROPERLY CALCULATING DEFICIT AND TOTAL INFLOW VOLUME USED CORRECTLY FOR OVER AN HOUR OF THE CASE, THAN AFTER ABOUT AN HOUR OF RESECTION T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10611535 ↗
• MalfunctionAug 13, 2019Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CONTROL UNIT FLUID MANAGEMENT WAS NOT CALCULATING CORRECTLY AND HAD DEFICIT AS IT WAS SHOWN AT MAXIMUM HOWEVER MANUAL CALCULATION SHOWED 500 ML AND NOT 2500 ML. IN ADDITION, THERE WERE ISSUES FITTING THE HANDPIECES CONNECTOR INTO THE CONTROL UNIT AS IT HAD A SMALL CRACKED AND WHEN PRESSED THIS CAN BE CONNECTED BUT WITH DIFFICULTY. THERE WAS NO FAILURE OF THE DEVICE IN THE PATIENTS, ALL ISSUES WERE OUTSIDE WITH THE CIRCULATION STAFF. THIS WAS AN OUT OF BOX FAILURE SINCE THESE WERE BRAND NEW AND HAVE NOT PREVIOUSLY BEEN USED. THE PROCEDURE WAS STILL COMPLETED. THERE WAS NO PATIENT INJURY. PHOTOS WERE SUBMITTED ILLUSTRATING THE ISSUE WITH THE FAULTY HANDPIECE CONNECTOR WITH CRACKED. HOWEVER AN ALTERNATIVE HANDPIECE WAS TRIED POST PROCEDURE AND THIS WAS ALSO DIFFICULT TO INSERT. THE CONNECTIONS DID NOT ALIGNED IN THE CONTROL UNIT FOR THE HANDPIECE TO CONNECT INTO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8891385 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173489. One submission often covers many models, so check the product and lot details in each record.

• Z-2561-2021 · Jun 18, 2021 · Open, Classified
  Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000