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

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04056702002145), received between May 31, 2019 and May 17, 2023 — classified as 15 malfunctions.

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

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.

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "BRIEF DESCRIPTION: INCORRECTLY CALCULATING DEFICIT PROBLEM DESCRIPTION. PROBLEM DESCRIPTION CALLER: HOLOGIC EMPLOYEE NAME: (B)(6) FOR ACCOUNT (IF NOT REPORTER): (B)(6) PART REPORTING DESCRIPTION: AQL-100P DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: (B)(6). DATE OF PROCEDURE: (B)(6) 2023. ISSUE REPORTED: INCORRECTLY CALCULATING DEFICIT. TROUBLESHOOTING PERFORMED: CUSTOMER REPORTS THAT SYSTEM IS INCORRECTLY CALCULATING DEFICIT. NO FURTHER. INFORMATION IS AVAILABLE. PATIENT STATUS: NO INJURY REPORTED OR PAE . DR. WHO PERFORMED THE PROCEDURE: UNKNOWN. HOW DID THE PROCEDURE COMPLETE: UNKNOWN. PATIENT/USER IMPACT: NO IMPACT REPORTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944917 ↗
• MalfunctionApr 28, 2022Improper Flow or Infusion

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "CUSTOMER W. BRAUN IS REPORTING THAT THIS SYSTEM DRAINING TOO QUICKLY AND THE DEFICIT IS OFF. TECH SUPPORT PROVIDED HIM WITH THE AQL INSTRUCTIONS FOR USE AND ASKED THAT HE PERFORM ALL THE TESTS LISTED. ONCE HE HAS DONE SO, TO REPORT BACK TO US VIA EMAIL. IT IS UNKNOWN IF THIS SYSTEM IS RETURNING AT THIS TIME. PUMP SERIAL - (B)(4) CASE - 01025903 CART/SCALE SERIAL - (B)(4) CASE - TECH SUPPORT HAS INFORMED TERRITORY MANAGER TODD CROWDER OF THIS REPORT. THERE HAS NOT BEEN AN UPDATE. TECH SUPPORT WILL FOLLOW UP WITH HIM. PATIENT/USER IMPACT NO IMPACT REPORTED"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14243197 ↗
• MalfunctionApr 13, 2022Pressure Problem

  "WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: ""SURGICAL APPLICATIONS SPECIALIST (APPS SPEC) RECEIVED A TRANSFERRED CALL FROM GSS TECH SUPPORT REP, (B)(4), ON (B)(6) 2022 @ 7:50AM PST. CUSTOMER, (B)(6), STATED THE DR. IS USING MYOSURE REACH TRD AND IS HAVING AN ISSUE WITH DISTENSION. THE CUSTOMER PLACED APPS SPEC ON SPEAKER PHONE WITH THE DR. THE DR. EXPLAINED THAT ALL WAS FINE DURING DIAGNOSTIC PORTION, BUT WHEN INSERTING THE DEVICE INTO THE CAVITY THERE WAS POOR DISTENSION. CUSTOMER NOTICED A -220 ON DEFICIT. APPS SPEC CONFIRMED THE CUSTOMER WAS USING THE AQUILEX 100P PUMP (SERIAL (B)(4)). APPS SPEC CONFIRMED NOTHING WAS LAYING ACROSS THE CANISTERS TO INDICATE A NEGATIVE DEFICIT. APPS SPEC ASKED FOR SET PRESSURE. DR. STATED THE SET PRESSURE WAS INCREASED TO 110MMHG. APPS SPEC ASKED ABOUT THE VACUUM SETTING. CUSTOMER STATED VACUUM IS BETWEEN MEDIUM AND HIGH. APPS SPEC HAD THE CUSTOMER LOWER THE VACUUM TO THE LOWEST SETTING. APPS SPEC CONFIRMED PATIENT#S MAP WAS AT 63MMHG. THE DR. STATED SHE WAS GOING TO STOP AT THIS POINT. AS APPS SPEC WAS GATHERING THE SERIAL NUMBER OF THE PUMP, APPS SPEC HEARD THE REACH DEVICE CUTTING. IT IS UNCERTAIN IF THE DR. WAS ABLE TO RESTORE DISTENSION W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106349 ↗
• MalfunctionApr 7, 2022Inadequate User Interface; Infusion or Flow Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "SURGICAL APPLICATIONS SPECIALIST RECEIVED A CALL FROM CUSTOMER, REQUESTING ASSISTANCE WITH AQUILEX AFTER A MYOSURE PROCEDURE. CUSTOMER STATED PROCEDURE IS NOW COMPLETE AND THERE IS 2L UNACCOUNTED FOR AND CUSTOMER IS UNSURE OF WHAT HAPPENED. CUSTOMER STATED THERE IS NO FLUID ON THE FLOOR, OR DRAPE. ALL FLUID HAS BEEN RETURNED TO CANISTERS. CUSTOMER STATED 2, 3L BAGS WERE HUNG. SURG APPS ASKED FOR DEFICIT ON AQULIEX DISPLAY. CUSTOMER STATED DEFICIT SHOWED 395 BUT IT HAS BEEN ZEROED EARLIER BECAUSE IT WAS DINGING. SURG APPS ASKED FOR DEFICIT WHEN IT WAS ZEROED. CUSTOMER STATED PREVIOUS DEFICIT WAS 1200. SURG APPS STATED 1200 PLUS 395 IS 1595 WHICH IS NOT FAR OFF FROM 2L DEFICIT MENTIONED. SURG APPS ASKED FOR MANUAL COUNT. SURG APPS ASKED HOW MANY BAGS WERE USED AND IF THERE WAS ANY SALINE LEFT IN THEM. CUSTOMER STATED THERE WERE 2 3L HUNG AND THERE WAS ABOUT 500 LEFT IN EACH ONE. SURG APPS ASKED FOR TOTAL FLUID IN ALL 4 CANISTERS. CUSTOMER STATED THERE WAS ABOUT 2700 TOTAL ON ALL CANISTERS. SURG APPS STATED INFORMATION PROVIDED WOULD EQUAL A MANUAL COUNT OF APPROXIMATELY 2300. SURG APPS STATED BASED ON INFORMATION BEING PROVIDED CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047837 ↗
• MalfunctionDec 8, 2021Defective Device

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TERRITORY MANAGER, REPORTS THAT THEY HAD AN AQUILEX SYSTEM THAT WAS GIVING A NEGATIVE DEFICIT DURING A CASE. THE SYSTEM STARTED PROPERLY WITH A DEFICIT OF 100, THEN IT BEGAN TO DECLINE TO -295. ACTUAL DEFICIT WAS ROUGHLY 500 WITH A MANUAL COUNT. (B)(6) REPORTS THAT THE BLADDER WAS NOT EMPTIED IN THE UNDERBUTTOCKS OR PRIMED, AS THERE WAS NO REASON FOR THIS. REP WAS PRESENT. NO PATIENT IMPACT REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962838 ↗
• MalfunctionJun 21, 2021Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  TECHNICAL SUPPORT WAS CONTACTED BY (B)(6), TERRITORY MANAGER, TO REPORT CUSTOMER OWNED AQUILEX SYSTEM IS SHOWING A NEGATIVE DEFICIT AND IS DUE FOR A PM.

  Patient problems: Insufficient Information

  MAUDE report 12030850 ↗
• MalfunctionMar 10, 2021Incorrect, Inadequate or Imprecise Result or Readings

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "(B)(6) IN BIO MED REPORTS STAFF WAS USING AQUILEX PUMP SERIAL NUMBER (B)(4) AND CART SERIAL NUMBER (B)(4) STAFF IS REPORTING DEFICIT WAS INACCURATE. SYSTEM IS NOT DUE FOR A PM UNTIL (B)(6). SHE IS GOING TO RUN THE ANNUAL TESTING AND LET US KNOW THE RESULTS. REP BEN SUMMERHAYES NOTIFIED. ANNA WAS GOING TO RE-RUN THE TESTING AND NOTIFY TECH SUPPORT IF THEY NEED TO GET SYSTEM REPLACED."

  Patient problems: Insufficient Information

  MAUDE report 11455538 ↗
• MalfunctionAug 12, 2020Volume Accuracy Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "PROBLEM DESCRIPTION: PLEASE REFER TO CASE 693940 INVOLVING S/N (B)(6) PROVIDED, THE GENTLEMAN MENTIONED ON (B)(6) 2020 THE ISSUE MAY BE DEFICIT RELATED YET THIS MAY NOT BE CONFIRMED, PROCEDURE DATE (B)(6) 2020. THIS IS ONE ISOLATED CASE. TS RECOMMENDED APPROPRIATE TROUBLESHOOTING FOUND IN THE IFU TO CONFIRM PROPER FLUID FLOW AND DEFICIT VARIANCE IS WITHIN SPEC. NO RETURN REQUIRED AT THIS TIME, NO INJURY AND NO DAMAGE REPORTED." "(B)(6) 2020 THOMAS CONTACT TS TO DISCUSS THE OUTCOME OF TESTING THE UNIT. AFTER REPEATED TESTS BY FOLLOWING THE OPERATORS MANUAL THE SYSTEM REVEALS A REPEATED OUT OF SPEC DEFICIT TOLERANCE. THE GENTLEMAN ALSO PROVIDED C&S S/N (B)(6), THE GENTLEMAN PREFERS TO RETURN ONLY THE PUMP AT THIS TIME AND ONCE THE PUMP ARRIVES WILL TEST THE UNIT WITH THE CURRENT C&S TO CONFIRM THE ISSUE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10395230 ↗
• MalfunctionApr 9, 2020Defective Device

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TECHNICAL SUPPORT WAS CONTACTED BY (B)(6) # TM REGARD-ING AQUILEX PUMP 1302CE183 AND SCALE 1607CE0278. THE TM STATED THAT THE CUSTOMER HAS DEFICIT ISSUES. "

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9942496 ↗
• MalfunctionDec 13, 2019Defective Component

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TECHNICAL SUPPORT WAS CONTACTED BY ERIC KOLLER TERRITORY MANAGER, TO REPORT CUSTOMER OWNED AQUILEX SYSTEM IS HAVING DEFICIT ISSUES. ERIC PERFORMED THE TESTING AND IT FAILED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9465315 ↗
• MalfunctionNov 8, 2019Defective Device

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TECH SUPPORT WAS CONTACTED BY (B)(6) TERRITORY MANAGER, TO REPORT AQUILEX SYSTEM NOT WORKING CONSISTENTLY WITH ACCURACY. 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)(6) NOTED CUSTOMER HAS REPORTED A DEFICIT THAT IS 1500 HIGHER THAN IS SHOULD BE AT TIMES AS WELL AS OCCASIONALLY REGISTERING A NEGATIVE DEFICIT. MIKE ASSISTED CUSTOMER IN RUNNING THE FLUID DEFICIT TESTING AND IT DID NOT COME OUT WITHIN THE PERMITTED LIMITS. UNIT WAS PULLED FROM SERVICE. THEY CHECKED THAT ALL TUBING WAS CONNECTED CORRECTLY, NOTHING WAS HANGING ON THE WHITE CANISTER SCALE HOLDER, NO OBVIOUS REASON WHY THIS IS NOT WORKING CORRECTLY. NO PATIENT INJURY REPORTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9295100 ↗
• MalfunctionOct 11, 2019Defective Component

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: " TECHNICAL SUPPORT WAS CONTACTED BY RHONDA MYERS TERRITORY MANAGER, TO REPORT HOLOGIC OWNED AQUILEX SYSTEM IS "THE BELOW AQUILEX PUMP/SCALE CONTINUE TO SHOW A NEGATIVE DEFICIT. THERE HAS BEEN NO REPORTED ADVERSE EVENTS, ACCOUNT HAS JUST BEEN USING PUMP AND MAN-UALLY CALCULATING THE DEFICIT." PUMP SERIAL (B)(6) REPORTED IN CASE (B)(4) TRACKING (B)(4) CART SERIAL (B)(6) REPORTED IN CASE (B)(4) TRACKING (B)(4) CONTACT IS (B)(6). SR NOTE 1: POTENTIAL PATIENT IMPACT? NO HARM REPORTED"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178330 ↗
• MalfunctionAug 9, 2019Defective Device

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TM CONTACTED TECHNICAL SUPPORT ON: 07/10/2019 REGARDING CUSTOMER OWNED AQUILEX PUMP SERIAL NUMBER (B)(4) AND CART & SCALE SERIAL (B)(4). THE CUSTOMER REPORTED THAT THE PUMP IS NOT CALCULATING DEFICIT CORRECTLY. THE REP WOULD LIKE TO HAVE THIS REPLACED ALONG WITH THE AQUILEX PUMP."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8877768 ↗
• MalfunctionJun 12, 2019Incorrect Measurement

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TECHNICAL SUPPORT WAS CONTACTED BY (B)(6), TERRITORY MANAGER, TO REPORT HOLOGIC OWNED AQUILEX SYSTEM THAT HAS INACCURATE FLUID DEFICITS. THEY HAD A MANUAL DEFICIT COUNT OF 200 AND THE SYSTEM READ THE DEFICIT WAS 2400. HEATHER REQUESTS WE SEND REPLACEMENT AS CUSTOMER DOES KNOW THE PROPER TROUBLESHOOTING AND TESTING. THEY NEED A REPLACEMENT FOR CASES OR THEY WILL NOT USE THE SYSTEM AND IT'S A COMPETITIVE ACCOUNT. PUMP SERIAL (B)(4) REPORTED IN (B)(4). CART SERIAL (B)(4) REPORTED IN (B)(4)."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8690348 ↗
• MalfunctionMay 31, 2019Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message

  WE WERE NOTIFIED OF THE FOLLOWING EVENT: "(B)(6) CONTACTED TECHNICAL SUPPORT (TS) (B)(6) 2019. SHE WANTED TO DISCUSS AN AQUILEX PROCEDURE. TS SUCCESSFULLY TRANSFERRED THE CALL TO APPLICATION SPECIALIST. POTENTIAL PATIENT IMPACT? NO HARM REPORTED. TS RESOLUTION: SURGICAL APPLICATIONS SPECIALIST RECEIVED A TRANSFERRED CALL FROM GSS TECHNICAL SUPPORT REPRESENTATIVE (B)(6). HOLOGIC TM, (B)(6), CALLED WITH A QUESTION REGARDING AQUILEX (B)(4) TM STATED AQUILEX WAS USED DURING A PROCEDURE. TM STATED AT END OF CASE "SCALE OVERLOAD" MESSAGE WAS DISPLAYED ON PUMP. TM STATED FRONT CANISTER WAS FULL BUT THERE WAS NO CORDS OR ANY ADDITIONAL WEIGHT ON CANISTERS THAT COULD BE OBSERVED. TM STATED DEFICIT WAS ALSO INCORRECT. TM STATED DEFICIT ON PUMP READ 230 AND MANUAL DEFICIT COUNT WAS 1500. SURG APPS ASKED IF TM HAD SERIAL NUMBER OFF OF CART/SCALE. TM DENIED. SURG APPS STATED SERIAL NUMBER OFF SCALE WOULD BE NEEDED TO INVESTIGATE. SURG APPS STATED SURG APPS WOULD RECOMMEND HOSPITAL BIOMED DEPARTMENT RUN CHECKS LOCATED IN IFU TO ENSURE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS. TM ASKED IF SURG APPS COULD EMAIL IFU. SURG APPS CONFIRMED. SURG APPS EMAILED TM IFU TO FORWARD TO HOSPITAL BIOMED DEPA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8657964 ↗