Aquilex Fluid Control System AQL-100PBSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04056702006914), received between Jun 17, 2022 and Oct 16, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K172040); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 17, 2023Open, Classified

   The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload

   Z-2629-2023 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "ISSUE REPORTED: AT MID-CASE FOR APPROXIMATELY 3 MINUTES, THE DEFICIT WAS SHOWING AS A NEGATIVE NUMBER. TROUBLESHOOTING PERFORMED AND ADDITIONAL DETAILS: RIGHT BEFORE ENDING THE CASE, THE NEGATIVE SIGN WENT AWAY TO SHOW A FINAL POSITIVE DEFICIT. PROCEDURE WAS COMPLETE AND PATIENT WAS UNHARMED. GSS TS CONFIRMED DEFICIT TEST WAS NOT PERFORMED POST OP. CUSTOMER DID NOT CHANGE THE SUPPLY BAG, CANISTER, OR ANY TUBING WHEN THIS EVENT OCCURED. FINAL DEFICIT READING ON PUMP WAS 235MLS; MANUAL COUNT NOT PERFORMED. HOW DID THE PROCEDURE COMPLETE: WITH THE SAME EQUIPMENT PROCEDURE SETTING: CLINICAL DATE OF PROCEDURE: ON (B)(6) 2025."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308283 ↗
• MalfunctionSep 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "THE DEFICIT STOPPED RECORDING HALF WAY THROUGH THE PROCEDURE USING XL MYOSURE DEVICE. THE CUSTOMER HUNG A TOTAL OF (16), 3L SALINE BAGS (TOTAL OF 48,000MLS) TO REMOVE A VERY LARGE FIBROID. THE DR. USED 3-4 MYOSURE XL DEVICES. THE CUSTOMER HAD TO USE 16-17 CANISTERS THROUGHOUT THE PROCEDURE. TROUBLESHOOTING: ONCE DEFICIT STOPPED ON 0MLS, THE CUSTOMER CONTINUED USING THE SYSTEM BUT USED MANUAL COUNT. THE TM EXPLAINED THE CUSTOMER SUCTIONED ABOUT 400CC?S FROM THE UNDER BUTTOCKS DRAPE. AFTER THE PROCEDURE CUSTOMER PRESSED UP AND DOWN ARROWS TO SHOW THE AMOUNT OF FLUID USED DURING THE PROCEDURE AND SCREEN SHOWED 0MLS. MANUAL COUNT BY REP WAS 800MLS BUT THE DR. RECORDED 200MLS FOR DEFICIT FOR THERE WAS A LOT OF FLUID ON THE FLOOR. ADDITIONAL INFORMATION APPS SPEC EXPLAINED THERE IS A SOFTWARE ANOMALY WITH THE AQL-100PBS. APPS SPEC EXPLAINED THAT ONCE TOTAL FLUID EQUALS 30,000MLS, THE DEFICIT WILL START TO COUNT BACKWARD TO ZERO. IT IS RECOMMENDED TO PERFORM A MANUAL COUNT GOING FORWARD. APPS SPEC STATED: ? BE COGNIZANT WHEN YOU HANG YOUR TENTH 3,000 LITER BAG? ONCE THE SYSTEM FULLY DEPLETES THAT TENTH BAG THE INFLOW COUNT WILL HIT 30,000 WHI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736008 ↗
• MalfunctionJul 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "THE FLUID DEFICIT DROPPED FROM 1700 TO 0 INSTANTLY WITHOUT HAVING COLLECTED THAT AMOUNT FROM THE UNDERBUTTOX DRAPE AS THERE WAS NONE PRESENT AT THAT TIME. (B)(6) WAS PRESENT IN THE ROOM AND THE SCALES HAD NOT BEEN TOUCHED, A CANISTER WAS NOT BEING CHANGED AND A SALINE BAG WAS NOT BEING HUNG AT THAT TIME. THE PHYSICIAN ENDED THE CASE WITH THE LAST RECORDED DEFICIT OF 1700 AND CHOSE NOT TO MOVE FORWARD. PATIENT STATUS: NO INJURY REPORTED, NO EXTENDED HOSPITAL STAY OR ADDITIONAL TREATMENT NEEDED. ADDITIONAL INFORMATION: TECH SUPPORT IS CONFIRMING THE SYSTEM IS FUNCTIONING CORRECTLY"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414095 ↗
• MalfunctionOct 4, 2022False Negative Result; Output Problem; False Negative Result; Output Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING NOTIFICATION OF RECEIVED HOSPITAL REPORTS FROM HEALTH (B)(6): "AQUILEX MACHINE BME1139 MALFUNCTIONED DURING PROCEDURE. FOLLOWING CANNISTER CHANGE AQUILEX MACHINE SHOWED NEGATIVE DEFICIT OF -120 AND SECONDS LATER SHOWED NEGATIVE DEFICIT OF -395 AND QUICKLY ESCALATED TO -450 MLS OF SODIUM CHLORIDE. DR. MADE AWARE AT THIS TIME AND AN IN AND OUT FLUID BALANCE WAS DONE AND DETERMINED AT THAT TIME TO BE OF NO DEFICIT. REP FOR THE AQUILEX MACHINE WAS CALLED AT THIS TIME AND WAS AVAILA-BLE ONLY BY PHONE. HE WAS UNABLE TO DETERMINE WHY THE MACHINE WAS GIVING THIS NEGATIVE DEFICIT VALUE. PROCEDURE FOR FLUID BAG CHANGE AND CANNISTER CHANGE DONE AS ACCORDING TO MANUFACTURER'S SUGGESTION AND AS STATED BY EQUIPMENT REP. DURING SECOND CANNISTER CHANGE THE FLUID BALANCE QUICKLY WENT TO -50. HIGH FLUID LOSS ALARMED AT THIS TIME AND THE DEFICIT WENT BACK DOWN TO -5 MLS. DURING THE CASE SURGEON NOTIFIED OF FLUID DEFICIT BY NURSES IN THE ROOM ACCORDING TO BAGS IN AND CANNISTERS OUT. NOTIFIED AT 500 MLS, 800 MLS, 1500 MLS, 2100 MLS, 2400 MLS AND FINAL 2800 MLS" ADDITIONAL INFORMATION RECEIVED: "(B)(6) 2022 TECH SUPPORT REACHED OUT TO THE CUSTOMER J.P. REQUESTING A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535228 ↗
• MalfunctionSep 24, 2022Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "(B)(4): BRIEF DESCRIPTION. DEFICIT DROPPED TO -999 DURING PROCEDURE. PROBLEM DESCRIPTION REPORTER: (B)(6), PART RETURNING DESCRIPTION: DATE OF PROCEDURE: (B)(6) 2022, DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: (B)(6) 2022, ISSUE REPORTED: DEFICIT DROPPED TO -999 DURING PROCEDURE . TROUBLESHOOTING PERFORMED: DURING A HYSTEROSCOPY, THE DEFICIT SUDDENLY DROPPED TO -999. THE PROCEDURE WAS ABORTED SHORTLY AFTER AS THE SURGEON PERFORATED WITH THE SCOPE (CASE 01120410). THIS DEFICIT ISSUE HAS HAPPENED IN A PREVIOUS CASE (CASE 01095004) WHERE THE DEFICIT SUDDENLY DROPPED FROM 2000 TO 200. NONE OF THE BAGS OR CANISTERS WERE BEING TOUCHED WHEN THIS HAPPENED. THE SYSTEM WAS FACING AWAY FROM V. AT THE TIME OF DEFICIT CHANGE, V. WAS NOTIFIED BY A SCRUB TECH THAT IT HAPPENED. POWER CABLE WAS NOT DRAPED OVER SYSTEM OR CANISTERS DURING PROCEDURE. THE DEFICIT CHANGED AFTER THE PERFORATION OCCURRED, HOWEVER V. STATES THE PROCEDURE WAS VERY QUICK. V. DID DEFICIT/FLOW RATE TESTS AND SCALE TEST, AND THE SYSTEM PASSED. HOW DID THE PROCEDURE COMPLETE: ABORTED . PATIENT STATUS: NO INJURY REPORTED OR P.AE. DR. WHO PERFORMED THE PROCED

  Patient problems: Insufficient Information

  MAUDE report 15476431 ↗
• MalfunctionSep 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: FOLLOW UP CALLED IN YESTERDAY - AQL DEFICIT ISSUES. REPORTER: (B)(6) FOR ACCOUNT (IF NOT REPORTER): PART RETURNING DESCRIPTION: RM-AQL-100PBS SERIAL NUMBER OF REPORTED ITEM: (B)(4).. DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: (B)(6) 2022. ISSUE REPORTED: DEFICIT-80ML. TROUBLESHOOTING PERFORMED: (B)(6) EXPLAINED THAT THE CUSTOMER RAN INTO A FINAL DEFICIT OF -80ML IN A RECENT PROCEDURE (FINDING OUT DATE). (B)(6) ADVISED TO RUN A FLUID DEFICIT TEST. (B)(6)EXPLAINED THAT THIS ALSO HAD A -80ML FINAL READING. (B)(6) WILL ALSO RUN A SCALE TEST TO CONFIRM A DAMAGED SCALE. SENT (B)(6) THE DEFICIT QUESTIONS. WAITING ON REPLY. HOW DID THE PROCEDURE COMPLETE: YES. PATIENT STATUS: NO. INJURY REPORTED OR PAE. DR. WHO PERFORMED THE PROCEDURE: UNKNOWN. REPLACEMENT REQUESTED: Y. IS PRODUCT RETURNING FOR INVESTIGATION: UNSURE. PATIENT/USER IMPACT NO IMPACT REPORTED. 08.09.2022 ADDITIONAL INFORMATION FROM HOLOGIC: THE CASE WAS CLOSED FOR OUR CUSTOMER SERVICE DEPARTMENT SINCE UNFORTUNATELY, WE COULDN'T GET ANY ANSWER BACK FROM CUSTOMER AFTER 3 ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427884 ↗
• MalfunctionAug 9, 2022Application Program Problem; Application Program Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWIND EVENT: "PART DESCRIPTION: AQL PBS SERIAL NUMBER OR, LOT NUMBER OF REPORTED ITEM: 1911CE1150 , DATE OF PROCEDURE: (B)(6) 2022, DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: (B)(6) 2022, ISSUE REPORTED: CUSTOMER CALLED TM EXPLAINING THAT DURING A PROCEDURE, THE DEFICIT JUMPED FROM 2000MLS DOWN TO 200MLS. TM STATED THE FLUID DEFICIT TEST PASSED AFTER CHECKING POST OP. THE CUSTOMER STATED 19+ SALINE BAGS WERE USED IN THE 2-HOUR PROCEDURE. THE CUSTOMER LEFT ALL FLUID BAGS ON THE HOOKS AND DID NOT LIFT ANY BAGS WHILE REPLACING DURING PROCEDURE. THE CUSTOMER ALSO CLAIMED THE DEFICIT WENT NEGATIVE AT SOME POINT DURING THE PROCEDURE. TROUBLESHOOTING PERFORMED: NO INFORMATION PROVIDED HOW DID THE PROCEDURE COMPLETE: DESPITE THE INACCURACIES OF THE DEFICIT, THE PROCEDURE COMPLETED WITHOUT INJURY. PATIENT STATUS: NO INJURY REPORTED. REPLACEMENT REQUESTED: N. LETTER OF INVESTIGATION REQUESTED: N. IS PRODUCT RETURNING FOR INVESTIGATION: N. SITE CONTACT INFORMATION: NA. ADDITIONAL INFORMATION: APPS SPEC CONFIRMED MANUAL COUNT WAS 1500MLS AND PRESSURE WAS SET TO 80MMHG THROUGHOUT THE PROCEDURE. THE MEAN ARTERIAL PRESSURE (MAP) IS UNKNOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189747 ↗
• MalfunctionJun 17, 2022Application Program Problem; Application Program Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "NICK M., CLINICAL ACCOUNT MANAGER, REPORTS THAT DURING AN AQUILEX TRIAL PROCEDURE, THE DEFICIT REACHED ABOUT 2000ML AT WHICH POINT IT BEGAN TO REDUCE STEADILY DOWN TO 0. UNKNOWN IF PROCEDURE WAS COMPLETED. NICK PERFORMED SCALE TEST ON SYSTEM AND DEFICIT TEST, WHICH BOTH PASSED. NICK AND HIS TM ARE´ REQUESTING TO HAVE THE AQUILEX REPLACED AS THIS IS THE BEGINNING OF A TRIAL. REP WAS PRESENT. NO PATIENT IMPACT REPORTED. AWARENESS/PROCEDURE DATE (B)(6) 2022 UPDATE 5/18/22: APPLICATIONS SPECIALIST (APPS SPEC) RECEIVED A CALL FROM (B)(6), ON (B)(6) 2022 @ 12:40PM PST. BRANDON ASKED APPS SPEC TO ASSIST WITH A REPORT OF AN INACCURATE DEFICIT DURING AN AQUILEX PBS PROCEDURE THAT OCCURRED TODAY. BRANDON PROVIDED THE CAM#S INFO TO CALL AND DISCUSS. APPS SPEC RECEIVED A CALL FROM NICK. APPS SPEC CONFIRMED THE INITIAL DEFICIT WAS 2000MLS MIDWAY THROUGH THE PROCEDURE HOWEVER THERE WAS NO FLUID POOLING IN THE UNDER BUTTOCKS DRAPE (UBD), ON THE FLOOR OR UNDER THE PATIENT. FLUID WOULD FLOW IN AND SUCTION OUT WITHOUT INCIDENT. NO PAUSING OR STOPPING OF THE SYSTEM OCCURRED. NICK EXPLAINED THAT THE DR. WAS REMOVING A VERY LARGE FIBROID AND THERE WAS A LO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14731138 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172040. One submission often covers many models, so check the product and lot details in each record.

• Z-2767-2019 · Aug 14, 2019 · Terminated
  Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.