Aquilex® Fluid Control System AQL-100CBSRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04056702006556), received between Jun 12, 2019 and Aug 14, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 reports).

1 FDA recall record name this device's identifier.

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

Recalls naming this device

1. Aug 14, 2019Terminated

   The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

   Z-2767-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Measurement System Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50249288 ↗
• MalfunctionOct 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "ISSUE REPORTED: NEGATIVE DEFICIT. TROUBLESHOOTING PERFORMED AND ADDITIONAL DETAILS: THIS SYSTEM GAVE NEGATIVE DEFICIT TODAY. THE REPORTER PERFORMED A SCALE TEST AND EVERYTHING WAS +/- 20 ON THE SCALES EXCEPT THE BAG SCALE READ -5. WHEN REPORTER WAS CALLED TO THE ROOM THE NEGATIVE DEFICIT WAS READING -750 +. SHE ASKED THEM TO NOT RELY ON THE DEFICIT AND TO DO A MANUAL COUNT. HOW DID THE PROCEDURE COMPLETE: USING THIS SYSTEM. PROCEDURE SETTING: CLINICAL. DATE OF PROCEDURE: (B)(6) 2025."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404660 ↗
• MalfunctionJun 8, 2023Calibration Problem; Calibration Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "PROBLEM DESCRIPTION PROBLEM DESCRIPTION CALLER: HOLOGIC EMPLOYEE (TM) NAME: (B)(6). PART SHIP DATE: (B)(6) 2022. DATE OF PROCEDURE: (B)(6) 2023. DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: 5/4/2023. ISSUE REPORTED: NEGATIVE DEFICIT. TROUBLESHOOTING PERFORMED: PERFORMED A MANUAL COUNT. DR. WHO PERFORMED THE PROCEDURE: UNKNOWN. PATIENT STATUS: NO INJURY REPORTED OR PAE. REPLACEMENT REQUESTED: YES. IS PRODUCT RETURNING FOR INVESTIGATION: YES. DETAILED DESCRIPTION: THOMAS REPORTS THAT DURING A PROCEDURE TODAY, THE DEFICIT SUDDENLY DROPPED AND WENT DOWN TO -300 AND CONTINUED TO DROP. A MANUAL COUNT WAS REQUIRED TO COMPLETE THE CASE. THOMAS ALSO REPORTS THAT SIMILAR ISSUES HAVE HAPPENED IN OTHER CASES, HOWEVER HE DOES NOT KNOW SPECIFIC NUMBERS. THOMAS WAS PRESENT FOR THE CASE TODAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090023 ↗
• InjuryJun 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TM STATES THAT THE PATIENT WAS GOING THROUGH A MYOSURE/AQUILEX PROCEDURE AND THERE WAS A FLUID OVERLOAD. TM DOES NOT HAVE INFO ON WHICH MYOSURE DEVICE OR SN FOR AQUILEX SYSTEM. TM STATES THAT THE AQUILEX SYSTEM HAD A DEFICIT OF 6000 BUT THE MANUAL COUNT SHOWED 600. PATIENT IS BEING KEPT AT THE HOSPITAL DUE TO PULMINARY EDEMA."

  Patient problems: Pulmonary Edema

  MAUDE report 17078090 ↗
• MalfunctionDec 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "BRIEF DESCRIPTION: DEFICIT READINGS GOING TO NEGATIVE. PROBLEM DESCRIPTION: REPORTER: (B)(6). PART DESCRIPTION: AQUILEX SCALE. SERIAL NUMBER OR LOT NUMBER OF REPORTED ITEM: (B)(4). DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: (B)(6) 2022. ISSUE REPORTED: DEFICIT READINGS GOING TO NEGATIVE. REPLACEMENT REQUESTED: YES. IS PRODUCT RETURNING FOR INVESTIGATION: YES. ADDITIONAL PROCEDURE INFORMATION: TECHNICAL SUPPORT WAS CONTACTED BY (B)(6) WHO REPORTED THAT THE CUSTOMER JUST RECEIVED THIS SYSTEM LAST MONTH AND ARE HAV-ING ISSUES WHERE THE DEFICIT READING WILL GO TO NEGATIVE READING RANDOMLY. A REPLACEMENT IS REQUESTED FOR THE CUSTOMER. A REPLACEMENT SYSTEM IS BEING SENT ATTN -PR. (B)(4). PATIENT/USER IMPACT: NO IMPACT REPORTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995176 ↗
• MalfunctionApr 6, 2021Incorrect Measurement; Application Program Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TECHNICAL SUPPORT WAS CONTACTED BY (B)(6), TERRITORY MANAGER, TO REPORT HOLX OWNED AQUILEX SYSTEM "AQUILEX IS NOT CALCULATING THE DEFICIT CORRECTLY. IT BOUNCES AROUND AND RUNS NEGATIVE. THREE CASES WERE COMPLETED TODAY BUT ALL HAD TO BE MANUALLY COUNTED. NO ISSUES WITH THE PATIENTS. DATE OF CASE WAS (B)(6) 2021".

  Patient problems: Insufficient Information

  MAUDE report 11618235 ↗
• MalfunctionApr 6, 2021Therapeutic or Diagnostic Output Failure

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "DAYNA PAMMER, TERRITORY MANAGER, REPORTS THAT THE SCALE IS NOT WORKING ON A NEW AQUILEX SYSTEM. THE DEFICIT JUMPS WILDLY, AND WHEN TESTING THE SYSTEM DAYNA REPORTED THE DEFICIT WAS 800ML AFTER DISPENSING 800ML OF FLUID. REPLACING C&S. REP WAS PRESENT. NO PATIENT IMPACT REPORTED. AWARENESS/PROCEDURE DATE (B)(6) 2021"

  Patient problems: Insufficient Information

  MAUDE report 11618203 ↗
• MalfunctionApr 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Therapeutic or Diagnostic Output Failure

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: (B)(6) TM, IS REPORTING AN OOB FAILURE. THE CUSTOMER HAS EXPERIENCED ISSUES WITH THIS SYSTEM SINCE RECEIVING IT ABOUT 2 MONTHS AGO. THEY'VE BEEN SEEING INACCURATE READINGS FROM THE PUMP. TODAY'S CASE, EMILY WAS PRESENT AND WHEN THEY CONNECTED THE TISSUE SOCK, THE DEFICIT WAS READING -100. SINCE THEY DIDN'T HAVE ANOTHER SYSTEM, THEY HAD TO PERFORM A MANUAL COUNT INSTEAD. THEY ENDED UP WITH ABOUT 100 AS THE DEFICIT. PROCEDURE COMPLETED AND NO PATIENT INJURY. THE TM IS REQUESTING THAT THEY BE SHIPPED ANOTHER SYSTEM AS IT'S STILL UNDER WARRANTY. SETTING UP ADV REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618165 ↗
• MalfunctionFeb 14, 2020No Device Output; Suction Problem; Failure to Cut

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "POTENTIAL PATIENT IMPACT? NO HARM REPORTED. TS RESOLUTION: SURGICAL APPLICATIONS SPECIALIST (APPS SPEC) RECEIVED AN EMAIL TO CONTACT TM (B)(6) IN RE: TO THE PROCEDURE FROM (B)(6) THIS MORNING AT 7:06 AM PST. [CASE (B)(4) - SUCTION ISSUE, SOLVED]. APPS SPEC EXPLAINED TO (B)(6) THAT (B)(6) FROM (B)(6) CALLED IN TO REPORT AN ISSUE WITH THE SUCTION BUT THAT WAS RESOLVED AND THEN THE CUSTOMER HUNG UP. [CASE (B)(4) - MYOSURE ISSUE, NOT AQUILEX RELATED]. (B)(6) STATED IT SEEMS THE DR. AND STAFF ((B)(6)) HAD MORE ISSUES AFTER THE INITIAL CALL. (B)(6) STATED THIS WAS A LONG-COMPLICATED PROCEDURE AND DURING CUTTING A LARGE 6CM FIBROID THE CONTROL UNIT SHUT STOPPED WORKING THE CUTTING CEASED. [CASE (B)(4) - DEFICIT ISSUE, AQUILEX RELATED]. THE 2ND ISSUE WHILE USING THE AQUILEX THE DEFICIT STAYED AROUND 1900 FOR SOME TIME BUT THEN JUMPED TO 0 AND STAYED AT -62. THE CUSTOMER USED 12 CANISTERS AND FROM ALL THE CHANGING OUT AND PAUSING OF THE SYSTEM, ALL THAT JOSTLING, MAY BE THE REASON FOR THE JUMPING AROUND OF THE DEFICIT ON THE PUMP SCREEN. (B)(6) STATED DUE TO THAT THE CUSTOMER PERFORMED A MANUAL COUNT AND ENDED UP HAVING MORE FLUID COMING OUT TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9710865 ↗
• MalfunctionOct 18, 2019Nonstandard Device; Incorrect, Inadequate or Imprecise Result or Readings

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "INFORMATION RECEIVED BY EMAIL ON (B)(6) 2019 BY AREA REP STATING "WE HAVE AN AQUILEX PUMP WHERE THE DEFICIT HAS BEEN OFF BY OVER A 1000 AND IN THE NEGATIVES. IT FAILED THE SCALE TEST AND THE FLUID TEST. CAN WE HAVE A NEW ONE SHIPPED IN TO REPLACE IT? AQL-100P - (B)(4), AQL- 100CBS - (B)(4). "

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9207579 ↗
• InjuryOct 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: (B)(6) CONTACTED TECHNICAL SUPPORT TO REPORT THAT AQUILEX CART SERIAL NUMBER: (B)(6) IS ON THE RECALL LIST. THEY USED IT IN A PROCEDURE ON (B)(6) 2019 AND PATIENT RECEIVED TOO MUCH FLUID AND WAS TAKEN TO THE ICU. (B)(6) DID NOT HAVE ANY MORE INFORMATION ABOUT THE PROCEDURE. RISK MANAGEMENT IS INVOLVED. (B)(6) IS CALLING BACK WITH MORE DETAILS. THE CART#S BAG DEFLECTOR IS NOT LOOSE BUT THEY WILL NOT PER-FORM ANY TESTING ON THE CART AND WANT A REPLACEMENT SENT ASAP. RMA 561416 TRACKING: (B)(6). SR NOTE 1: POTENTIAL PATIENT IMPACT? POTENTIAL ADVERSE EVENT OR MDR. POTENTIAL ADVERSE EVENT MDR DETAILS: NATURE OF THE INJURY TOO MUCH FLUID".

  Patient problems: No Code Available

  MAUDE report 9178127 ↗
• MalfunctionSep 17, 2019Nonstandard Device; Defective Device

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TECHNICAL SUPPORT WAS CONTACTED BY (B)(6), TERRITORY MANAGER, TO REPORT CUSTOMER OWNED AQUILEX SYSTEM WHERE HE REPORTS [AFTER ZEROING OUT THE DEFICIT WOULD CONTINUALLY CLIMB TO 20ML WITHOUT THE INFLOW BEING ON. IT DID THIS APPROXIMATELY FOUR TIMES BEFORE THE CASE. DURING THE CASE THE DEFICIT WENT NEGATIVE FROM THE BEGINNING AND CONTINUED TO INCREASE IN THE NEGATIVE. RANDOMLY AND ONE POINT THE DEFICIT CHANGED FROM NEGATIVE TO A POSITIVE DEFICIT. THE POSITIVE DEFICIT WAS NOT IN THE VICINITY OF WHAT THE DEFICIT ACTUALLY WAS.] TECH SUPPORT REQUESTED THE TESTING FROM THE OPERATORS MANUAL BE PERFORMED ON THE SITE AS IT IS NORMAL FOR THE MACHINE TO GO INTO NEGATIVE DEFICITS BUT IT SHOULD BE ACCURATE READING. DUE TO THE VARIABLES THAT CAN THROW IT OFF WE REQUEST THE TESTING BE PERFORMED. HE WILL GO TO THE SITE AND SEE WHAT RESULTS WE GET. (B)(6) TESTED THE EQUIPMENT PER THE OPERATORS MANUAL WITH CUSTOMER AND IT MEETS THE OUTPUT TESTS IN SECTION 8. NO RETURNS. 2/6/2019 UPDATE - WE HAD OUR FIRST CASE TODAY WITH THE AQUILEX THAT WAS PREVIOUSLY HAVING PROBLEMS BUT PASSED ALL THE TESTS I PERFORMED IT. ALL THOUGH IT PASSED ALL TESTS WE ARE STILL HAV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9074439 ↗
• MalfunctionSep 17, 2019Nonstandard Device; Incorrect, Inadequate or Imprecise Result or Readings

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TECHNICAL SUPPORT WAS CONTACTED BY (B)(6), TERRITORY MANAGER, TO REPORT HOLOGIC OWNED AQUILEX SYSTEM. HOSPITAL STAFF CALLED (B)(6) REPORTING THE DEFICIT NOT REGISTERING AND THEN SHOOTING TO VERY LARGE NEGATIVE DEFICITS DURING A CASE. SHE WENT AND WAS PRESENT FOR THE NEXT CASE. THEY PRIMED THE SYSTEM THE NUMBERS ON THE DEFICIT READING NEVER CHANGED FROM 0 EVEN THOUGH I HAD THEM RUN OVER 300ML OF FLUID INTO THE UNDERBUTT DRAPE. THEY SWITCHED SYSTEMS AFTER THAT TO SUCCESSFULLY COMPLETE THE CASE. TECH SUPPORT ASKED FOR CONFIRMATION THAT FLUID HUNG ON THE SUPPLY HOOKS; CONFIRM THAT NOTHING BESIDES FLUID BAGS ARE BEING HUNG ON THE SUPPLY HOOKS. EVEN WHEN NOT IN USE, NOTHING (INCLUDING THE POWER CORDS) SHOULD BE HUNG ON THEM AS ITS SENSITIVE AS IT'S A SCALE; CONFIRM THERE IS NOTHING BESIDES CANISTER RINGS ON THE SCALE AT THE BOTTOM; CONFIRM THE PINK SHIPPING RUBBER TUBES WERE REMOVED FROM THE WHITE CANISTER RING HOLDER AREA. WE DO ADVISE THAT WE SWAP OUT BOTH PIECES. PUMP SERIAL (B)(4) REPORTED IN CASE (B)(4). CART SERIAL (B)(4) REPORTED IN CASE (B)(4). CONTACT AT FACILITY IS (B)(6). (B)(4) NOTED NOTHING EXCEPT FLUID WAS ON THE HOOKS; NOTHING

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9074436 ↗
• MalfunctionSep 17, 2019Nonstandard Device; Incorrect, Inadequate or Imprecise Result or Readings; Material Twisted/Bent

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "BENT- (B)(6) TM CONTACTED TECHNICAL SUPPORT TO REPORT THAT AQUILEX CART SERIAL NUMBER (B)(4) IS BENT AND GIVING NEGATIVE DEFICIT READINGS. IT IS HOLOGIC OWNED. CONTACT IS (B)(6) RMA (B)(4) TRACKING (B)(4)."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9074424 ↗
• MalfunctionAug 7, 2019Defective Device

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "MISC - SCOTTY PRIDDY # TEL. (B)(6) CONTACTED TECHNICAL SUPPORT ON: (B)(6) 2019 REGARDING CUSTOMER OWNED AQUILEX CART & SCALE SERIAL (B)(4) THE TM REPORTED THAT CART & SCALE IS HAVING DEFICIT ISSUES. THE TM WOULD LIKE THIS UNIT SWAPPED OUT. WARRANTY EXPIRES ON: 15-NOV-2019 CART & SCALE IS ON CASE#: (B)(4) THE PUMP IS ON CASE #: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8868256 ↗
• MalfunctionJul 8, 2019Failure to Calibrate

  WE WERE NOTIFIED OF THE FOLLOWING EVENT: "INFORMATION RECEIVED BY EMAIL ON JUNE 6, 2019 FROM AREA REP C/O CUSTOMER (B)(6) (EMAIL CCD) (B)(6) STATING "THE FOLLOWING ACCOUNT HAS A SCALE CALIBRATION ISSUE THAT NEEDS TO BE REPAIRED IMMEDIATELY. WE WERE IN A HYSTEROSCOPY CASE YESTERDAY (B)(6) 2019. DURING THE CASE, THE DEFICIT FLUCTUATED FROM A POSITIVE NUMBER ALL THE WAY UP TO 210 DOWN TO A NEGATIVE 180. INTERMITTENTLY DURING THE CASE. A TEST WAS RUN ON THE UNIT AND IT RAN NEGATIVE IN THE END AS WELL. PLEASE HAVE A REPLACEMENT UNIT SENT TO THIS FACILITY ASAP AS THEY ARE DOWN TO ONE USABLE UNIT. (B)(6). (B)(4).""

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8767233 ↗
• MalfunctionJun 12, 2019Defective Component

  WE WERE NOTIFIED OF THE FOLLOWING EVENT: "DEFICIT PROBLEMS - (B)(6) CONTACTED TECHNICAL SUPPORT REGARDING CUSTOMER OWNED AQUILEX PUMP SERIAL NUMBER (B)(4) THE TM REPORTED THAT THE AQUILEX SYSTEM IS HAVING DEFICIT ISSUES AND NEEDS TO BE REPLACED. PUMP IS ON CASE# (B)(4) THE CART & SCALE IS ON CASE # (B)(4) SHIPPING TO ATTN: (B)(6) NOTE 1:POTENTIAL PATIENT IMPACT? NO HARM REPORTED HAS SERVICE ORDERS? TRUE".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8690344 ↗
• MalfunctionJun 12, 2019Incorrect, Inadequate or Imprecise Result or Readings

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TECHNICAL SUPPORT WAS CONTACTED BY (B)(6), TERRITORY MANAGER, TO REPORT THE CUSTOMERS NEW AQUILEX SYSTEM WAS GIVING NEGATIVE INACCURATE FLUID DEFICITS TODAY. TECH SUPPORT ADVISED TO CHECK TO MAKE SURE THERE WAS NO PINK PACKING TUBES ON THE SCALE. TO CHECK TO MAKE SURE THE WHEELS ARE ON OK, THAT THE BAG DEFLECTOR AND OTHER PIECES DO NOT LOOK DAMAGED. TECH SUPPORT RECOMMENDED RUNNING THE TESTING IN THE OPERATORS MANUAL. (B)(6) WILL GO ON SITE LATER THIS WEEK TO RUN THE TESTS. PUMP SERIAL (B)(4) REPORTED IN CASE (B)(4). CART SERIAL (B)(4) REPORTED IN CASE (B)(4)".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8690337 ↗

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-2629-2023 · Jul 17, 2023 · Open, Classified
  Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the ir