Medex FS116Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10351688510969), received between Feb 14, 2022 and Mar 11, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (20 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Fluid/Blood Leak; Increase in Pressure

  IT WAS REPORTED THAT THE PRODUCT SEEMED TO FAIL AS THERE WERE OVERPRESSURE ALARMS AND SOLUTION LEAKED FROM THE FILTER. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571397 ↗
• MalfunctionJun 14, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE'S FILTER WAS LEAKING WHILE IT WAS USED ON THE PATIENT FOR AN INFUSION. THE LEAKING CAME FROM THE SEAL BETWEEN THE FILTER AND THE LINE PROXIMAL TO THE PATIENT. NURSING BROUGHT SYRINGE AND LINE BACK TO CHANGE LINES OUT, HOWEVER TECH COULD NOT DRAW FLUID BACK FROM THE IN-LINE FILTER AT ALL. AFTER CONFIRMING WITH TEAM THAT A REDUCED VOLUME (ABOUT 1 ML PER LINE) WAS READY TO SALVAGE THERAPY TODAY, A TECHNICIAN ATTACHED A NEW IN-LINE FILTER AND PRIMED AS PER STANDARD COMPOUNDING PROCEDURE FOR BRINEURA. SAME LEAKING HAPPENED IMMEDIATELY AFTER STARTING INFUSION AGAIN. THEY DISCUSSED POTENTIALLY TO SWITCH THIS NEW LINE LOT INSTEAD WHICH WOULD RESULT IN A TOTAL OF 2.5 ML TOTAL LOSS. THE TEAM AGREED WITH REDUCED DOSE TODAY IN LIEU OF DELAYING THERAPY FOR DAYS OR ANOTHER WEEK. THEY CONFIRMED THAT THERE WAS NO ISSUE WITH LEAKING WITH THIS NEW LINE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE OUTCOME OF THE EVENT WAS RESOLVED AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208134 ↗
• MalfunctionJan 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE AT LUER LOCK CONNECTION WAS OBSERVED. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229465 ↗
• MalfunctionDec 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE FILTER ON THE SET. THE LEAK WAS FOUND WHILE THE DRUG WAS ATTACHED TO THE PATIENT AT THE INPATIENT ONCOLOGY UNIT. THERE WAS NO PATIENT HARM, BUT THERE WAS A DELAY IN TREATMENT. THE MEDICAL INTERVENTION WAS CULTURE OBTAINED, AND ANTIBIOTICS GIVEN. THE LEAKAGE OCCURRED ON TWO SEPARATE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878342 ↗
• MalfunctionDec 6, 2024Leak/Splash; Leak/Splash

  IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING LEAKING ISSUES OCCURRING FROM THE FILTER ON THIS SET. NO PATIENT HARM WAS REPORTED. HOWEVER, THE INCIDENT DID CAUSE DELAY IN TREATMENT AND AT TIMES, RE-ADMISSION TO RE-START THE TREATMENT. ANTIBIOTICS WERE USED AS MEDICAL INTERVENTION. DELAY IN RESTARTING TREATMENT WAS DUE TO TIMING OF THE LEAK AND WHEN CHEMO PHARMACY WAS CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866998 ↗
• MalfunctionOct 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE NURSE INSERTED THE IV IN PRE-OP, THE IV/TUBING WAS LEAKING LACTATED RINGERS (LR) IV FLUID. REGISTERED NURSE DISCONNECTED AND RECONNECTED THE TUBING FROM THE IV HUB MULTIPLE TIMES AND IT CONTINUED TO LEAK LACTATED RINGERS FROM THE IV HUB. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433448 ↗
• MalfunctionJun 21, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FLUID LEAKS OUT OF THE TUBING DURING IV INFUSION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584407 ↗
• MalfunctionJun 21, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FLUID LEAKS OUT OF THE TUBING DURING IV INFUSION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584321 ↗
• MalfunctionJun 21, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FLUID LEAKS OUT OF THE TUBING DURING IV INFUSION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584106 ↗
• MalfunctionApr 29, 2024Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT FIVE OF THE FS116S CRACKED DURING THE USE. THE CUSTOMER ALSO EXPERIENCED FILTER LEAKS AND ALREADY PICKED UP THE BAD IV LINES. THREE SUITABLE SUBS DRAWINGS WERE PROVIDED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19202137 ↗
• MalfunctionApr 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE SET OF PEDIATRIC FILTERED TUBING WAS LEAKING OUT AROUND FILTER. TUBING REPLACED. THE MEDICAL INTERVENTION REQUIRED IV TUBING WAS CHANGED AFTER DISCOVERY OF LEAK. PATIENT WAS NOT TACHYCARDIC, HYPERTENSIVE, TACHYPNEIC AND DEVELOPED A LOW-GRADE FEVER (37.6C) AND WAS VERY RESTLESS. FOUND THE LEAK AND DETERMINED THE PATIENT HAD BEEN LEAKING DEXMEDETOMIDINE OUT OF HIS LINE FOR AROUND 4 HOURS BEFORE DISCOVERY. THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: Fever; High Blood Pressure/ Hypertension; Tachycardia

  MAUDE report 19133525 ↗
• MalfunctionApr 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE SET OF PEDIATRIC FILTERED TUBING WAS LEAKING OUT AROUND THE FILTER. TUBING REPLACED. THERE WAS PATIENT INVOLVEMENT. THE MEDICAL INTERVENTION REQUIRED WAS AN IV TUBING CHANGE AFTER DISCOVERY OF THE LEAK. THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127861 ↗
• MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS "A TREND OF MALFUNCTIONING FILTER MICROBORE INTRAVENOUS INFUSION TUBING THAT BEGAN STARTING 2023. THE TUBING LEAKS AT THE FILTER OR REQUIRES EXCESS PRESSURE TO PRIME/INFUSE FLUID. HAS IMPACTED FLOW OF MEDICATIONS SUCH AS INOTROPES AND SEDATION ON CRITICALLY ILL PEDIATRIC CARDIOVASCULAR PATIENTS IN THE OPERATING ROOM OR INTENSIVE CARE UNIT. ONE PATIENT IN 2023 HAD EPINEPHRINE LEAKING IN THE OPERATING ROOM DURING OPEN HEART SURGERY, POSSIBLY CONTRIBUTING TO A DELAY IN COMING OFF OF BYPASS. RE-ESCALATED TO THE MANUFACTURER ON THAT DAY, AND THEY CAME ON SITE 2023 TO RETRIEVE PRODUCT. AT THAT TIME, THEY MENTIONED THAT THE FILTER IS PROVIDED BY ANOTHER COMPANY. HAVE NOT STOPPED USE OF THE PRODUCT BUT HAVE RE-EDUCATED STAFF ON THE MANUFACTURER'S INSTRUCTIONS FOR USE WITH ONGOING ISSUE." THERE WAS NO PATIENT HARM REPORTED. NO PATIENT NAMES AVAILABLE. PRODUCT FAILURES OCCURRED DURING INFUSION, NOTICED HOURS OR DAYS INTO INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793721 ↗
• MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS "A TREND OF MALFUNCTIONING FILTER MICROBORE INTRAVENOUS INFUSION TUBING THAT BEGAN STARTING 2023. THE TUBING LEAKS AT THE FILTER OR REQUIRES EXCESS PRESSURE TO PRIME/INFUSE FLUID. HAS IMPACTED FLOW OF MEDICATIONS SUCH AS INOTROPES AND SEDATION ON CRITICALLY ILL PEDIATRIC CARDIOVASCULAR PATIENTS IN THE OPERATING ROOM OR INTENSIVE CARE UNIT. ONE PATIENT IN 2023 HAD EPINEPHRINE LEAKING IN THE OPERATING ROOM DURING OPEN HEART SURGERY, POSSIBLY CONTRIBUTING TO A DELAY IN COMING OFF OF BYPASS. RE-ESCALATED TO THE MANUFACTURER ON THAT DAY, AND THEY CAME ON SITE 2023 TO RETRIEVE PRODUCT. AT THAT TIME, THEY MENTIONED THAT THE FILTER IS PROVIDED BY ANOTHER COMPANY. HAVE NOT STOPPED USE OF THE PRODUCT BUT HAVE RE-EDUCATED STAFF ON THE MANUFACTURER'S INSTRUCTIONS FOR USE WITH ONGOING ISSUE." THERE WAS NO PATIENT HARM REPORTED. NO PATIENT NAMES AVAILABLE. PRODUCT FAILURES OCCURRED DURING INFUSION, NOTICED HOURS OR DAYS INTO INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793707 ↗
• MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS "A TREND OF MALFUNCTIONING FILTER MICROBORE INTRAVENOUS INFUSION TUBING THAT BEGAN STARTING 2023. THE TUBING LEAKS AT THE FILTER OR REQUIRES EXCESS PRESSURE TO PRIME/INFUSE FLUID. HAS IMPACTED FLOW OF MEDICATIONS SUCH AS INOTROPES AND SEDATION ON CRITICALLY ILL PEDIATRIC CARDIOVASCULAR PATIENTS IN THE OPERATING ROOM OR INTENSIVE CARE UNIT. ONE PATIENT IN 2023 HAD EPINEPHRINE LEAKING IN THE OPERATING ROOM DURING OPEN HEART SURGERY, POSSIBLY CONTRIBUTING TO A DELAY IN COMING OFF OF BYPASS. RE-ESCALATED TO THE MANUFACTURER ON THAT DAY, AND THEY CAME ON SITE 2023 TO RETRIEVE PRODUCT. AT THAT TIME, THEY MENTIONED THAT THE FILTER IS PROVIDED BY ANOTHER COMPANY. HAVE NOT STOPPED USE OF THE PRODUCT BUT HAVE RE-EDUCATED STAFF ON THE MANUFACTURER'S INSTRUCTIONS FOR USE WITH ONGOING ISSUE." THERE WAS NO PATIENT HARM REPORTED. NO PATIENT NAMES AVAILABLE. PRODUCT FAILURES OCCURRED DURING INFUSION, NOTICED HOURS OR DAYS INTO INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793698 ↗
• MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  GCM RECEIVED USER FACILITY MANDATORY MEDWATCH (MW5150083) ON 30-JAN-2024 THAT STATED: "A TREND OF MALFUNCTIONING FILTER MICROBORE INTRAVENOUS INFUSION TUBING BEGAN STARTING 2023 (SMITHS MEDICAL FS116). REPORTED TO THE MANUFACTURER (ICU MEDICAL) IN 2023. HAS BEEN DOCUMENTED ON PATIENT 7. TUBING LEAKS AT THE FILTER OR REQUIRES EXCESS PRESSURE TO PRIME/INFUSE FLUID. HAS IMPACTED FLOW OF MEDICATIONS SUCH AS INOTROPES AND SEDATION ON CRITICALLY ILL PEDIATRIC CARDIOVASCULAR PATIENTS IN THE OPERATING ROOM OR INTENSIVE CARE UNIT. ONE PATIENT IN 2023 HAD EPINEPHRINE LEAKING IN THE OPERATING ROOM DURING OPEN HEART SURGERY, POSSIBLY CONTRIBUTING TO A DELAY IN COMING OFF OF BYPASS. RE-ESCALATED TO THE MANUFACTURER ON THAT DAY, AND THEY CAME ON SITE 2023 TO RETRIEVE PRODUCT. AT THAT TIME, THEY MENTIONED THAT SMITHS/ICU MEDICAL DOES NOT MAKE THE FILTER THEMSELVES, BUT IT IS PROVIDED BY ANOTHER COMPANY. UTILIZED NETWORKING LISTSERVES TO IDENTIFY IF OTHER FACILITIES HAVE EXPERIENCED THE SAME ISSUE. AT LEAST ONE HOSPITAL) HAS EXPERIENCED THE SAME ISSUE IN THE SAME TIMEFRAME WITH A DIFFERENT BRAND PRODUCT THAT CONTAINS A FILTER THAT LOOKS ALMOST IDENTICAL TO THE ONE THAT WE USED. HAVE NOT RECEIVED U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793668 ↗
• MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS "A TREND OF MALFUNCTIONING FILTER MICROBORE INTRAVENOUS INFUSION TUBING THAT BEGAN STARTING 2023. THE TUBING LEAKS AT THE FILTER OR REQUIRES EXCESS PRESSURE TO PRIME/INFUSE FLUID. HAS IMPACTED FLOW OF MEDICATIONS SUCH AS INOTROPES AND SEDATION ON CRITICALLY ILL PEDIATRIC CARDIOVASCULAR PATIENTS IN THE OPERATING ROOM OR INTENSIVE CARE UNIT. ONE PATIENT IN 2023 HAD EPINEPHRINE LEAKING IN THE OPERATING ROOM DURING OPEN HEART SURGERY, POSSIBLY CONTRIBUTING TO A DELAY IN COMING OFF OF BYPASS. RE-ESCALATED TO THE MANUFACTURER ON THAT DAY, AND THEY CAME ON SITE 2023 TO RETRIEVE PRODUCT. AT THAT TIME, THEY MENTIONED THAT THE FILTER IS PROVIDED BY ANOTHER COMPANY. HAVE NOT STOPPED USE OF THE PRODUCT BUT HAVE RE-EDUCATED STAFF ON THE MANUFACTURER'S INSTRUCTIONS FOR USE WITH ONGOING ISSUE." THERE WAS NO PATIENT HARM REPORTED. NO PATIENT NAMES AVAILABLE. PRODUCT FAILURES OCCURRED DURING INFUSION, NOTICED HOURS OR DAYS INTO INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793665 ↗
• MalfunctionFeb 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID WAS LEAKING FROM THE FILTERS AND NOT THE TUBING FITTINGS ENTERING OR EXITING THE FILTER. THREE (3) TUBING SETS ARE AFFECTED. PRODUCT FAILURES OCCURRED DURING INFUSION, NOTICED HOURS OR DAYS INTO INFUSION. ALL AFFECTED PRODUCT LABELED AND DATED BY THE NURSING STAFF (NUMBER OF DAYS ON PATIENT, LOT NUMBER, AND DATE). THERE WAS NO PATIENT HARM REPORTED. POSSIBLE LOT NUMBERS REPORTED WERE: R23H04093 AND R23G31086.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18742063 ↗
• MalfunctionJan 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FILTER WAS LEAKING. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18457020 ↗
• MalfunctionNov 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE THE DEVICE WAS LEAKING "DISTAL TO FILTER". ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18078274 ↗
• MalfunctionJun 19, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE EVENT WAS DISCOVERED WHILE IN USE WITH A PATIENT, THE OUTCOME WAS RESOLVED, NO PATIENT HARM OCCURRED, AND NO MEDICAL INTERVENTION WAS NEEDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17157894 ↗
• MalfunctionFeb 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICU HAS HAD "7-8+" OCCURRENCES OF CRACKED/LEAKING FILTERS FROM THE SAME LOT, SO 9 FILES CREATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549589 ↗
• MalfunctionFeb 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICU HAS HAD "7-8+" OCCURRENCES OF CRACKED/LEAKING FILTERS FROM THE SAME LOT, SO 9 FILES CREATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549565 ↗
• MalfunctionFeb 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICU HAS HAD "7-8+" OCCURRENCES OF CRACKED/LEAKING FILTER FROM THE SAME LOT, SO 9 FILES CREATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549235 ↗
• MalfunctionFeb 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICU HAS HAD "7-8+" OCCURRENCES OF CRACKED/LEAKING FILTERS FROM THE SAME LOT, SO 9 FILES CREATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535607 ↗