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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056702002121), received between May 13, 2019 and Sep 27, 2024 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "ISSUE REPORTED: NEGATIVE DEFICIT TROUBLESHOOTING PERFORMED AND ADDITIONAL DETAILS: GARREN WAS PRESENT FOR THE PROCEDURE. IT WAS A LONG PROCEDURE USING ABOUT 10 BAGS OF FLUID AND MULTIPLE CANISTERS. THE DEFICIT HELD UP AROUND 1,000 FOR A MAJORITY OF THE CASE. AT THE END OF THE CASE, GARREN CHECKED THE DEFICIT GOING AND THE SYSTEM DISPLAYED - 9,999. THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFUL. HOW DID THE PROCEDURE COMPLETE: USING THIS SYSTEM DATE OF PROCEDURE: ON (B)(6) 2024. THIS SYSTEM IS NOT BEING RETURNED AT THIS TIME." ADDITIONAL INFORMATION Q1: WHICH MEDICAL PROCEDURE HAS BEEN CONDUCTED, E.G. DIAGNOSTIC OR THERAPEUTIC? A1: THERAPEUTIC FIBROID RESECTION MULTIPLE USING Q2: WHAT HAS BEEN DONE, E.G. UTERINE FIBROID REMOVAL? A2: UTERINE FIBROID RESECTION Q3: DID PERFORATION OCCUR? IF YES, WAS IT CONFIRMED USING LAPAROSCOPY? A3: NO Q4: WHICH PRESSURE HAS BEEN USED? A4: 80 & 90 Q5: WHICH DISTENTION MEDIUM HAS BEEN USED? A5: SALINE Q6: WHICH FLUID BAG SIZE WAS USED? A6: 3L Q7: WHICH DEFICIT VALUE WAS DISPLAYED ON THE PUMP AT THE END OF THE PROCEDURE? A7: DO NOT REMEMBER BUT REPORTED IT TO TECHNICAL SUPPORT Q8: WHIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20319921 ↗
• DeathAug 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TECHNICAL SUPPORT WAS CONTACTED BY A. MIRANTE - TERRITORY MANAGER TM WHO REPORTED THAT HE WAS PRESENT FOR A TISSUE REMOVAL PROCEDURE USING MYOSURE AND AQUILEX. THE PROCEDURE WAS GOING NORMAL THE DEFICIT WAS STEADY AT 1000-1300 AND WOULD INCREASE SLIGHTLY WHILE REMOVING THE TISSUE. THE DOCTOR THEN THOUGHT SHE SAW SOMETHING THAT LOOKED LIKE A PERFORATION. AT THAT POINT THE DEFICIT WAS INCREASING QUICKLY, AT 2500 THE DOCTOR STOPPED THE PROCEDURE. THE TM THEN LEFT THE ROOM SINCE THE DOCTOR MENTIONED THAT THEY WERE GOING TO DO AN ECHOCARDIOGRAM ON THE PATIENT ALONG WITH SOME OTHER TESTS. THIS PROCEDURE TOOK PLACE AROUND 9 AM AND LATER IN THE DAY HE RECEIVED A CALL FROM THE DOCTOR TELLING HIM THAT THE PATIENT HAD PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. MYOSURE - CASE: (B)(4)."

  Patient problems: Uterine Perforation

  MAUDE report 17570491 ↗
• MalfunctionMay 13, 2019Incorrect, Inadequate or Imprecise Result or Readings

  WE HAVE RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE MFR 3002914049-2019-00002: "ACCORDING TO THE REP THE AQUILEX IS STILL IN USE FOR CASES. THE OR MANAGER PROVIDED ADDITIONAL INFORMATION THAT THE SYSTEM WAS TESTED BY THEIR BIOMED DEPARTMENT AND THEY WERE NOT ABLE TO REPRODUCE THE REPORTED COMPLAINT CONDITION. THERE HAS BEEN NO ISSUES REPORTED WITH THE SYSTEM IN THE SUBSEQUENT CASES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8603017 ↗