ICU Medical B1115Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00840619045524), received between Jun 27, 2024 and May 7, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 reports).

188 other recalls cover devices cleared under the same FDA submission (K964435); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Crack

  AN EMAIL WAS RECEIVED REGARDING A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER, ALLEGING THAT THE LIPID FILTER WAS CRACKED AND THE PATIENT HAD TRIFUSE WITH LIPIDS IN ONE PORT AND CENTRAL VENOUS PRESSURE (CVP) IN A SECOND PORT. LIPIDS WERE BACKFLOWING INTO THE PRESSURE TUBING OF THE CVP TRANSDUCER AT THE TRIFUSE. THE CVP TRANSDUCER WAS CHANGED BUT THER WAS NO IMPROVEMENT TO THE TRIFUSE WAS CHANGED AND NO IMPROVEMENT. A CRACK WAS IDENTIFIED IN THE PLASTIC CONNECTING THE FILTER TO THE TRIFUSE, SO LIPIDS WERE BACKFLOWING INTO THE TRANSDUCER DUE TO THE INCREASED PRESSURE. SEVERAL ACCESSES TO LINE WITH INCREASED RISK FOR CLABSI, NEW LIPIDS WERE ORDERED AND PRIMED THROUGH THE NEW FILTER/TUBING. THE EVENT OCCURRED DURING INFUSION, AND THE PATIENT IS FEMALE WITH INITIAL SH BORN ON 24TH FEBRUARY 2026, WEIGHING 6KG. THERE WAS A PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119264 ↗
• MalfunctionApr 9, 2026Crack

  EVENT OCCURRED REGARDING A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT TWO SEPARATE ALARIS LIPID FILTERS WERE FOUND CRACKED AT THE LUER LOCK ATTACHMENT SITE. BOTH FILTERS WERE REMOVED FROM THE IV TUBING, AND THE TUBING WAS RE-PRIMED WITH NEW FILTERS. THE PATIENT INVOLVED IN THE EVENT WAS A 9-YEAR-OLD MALE WITH INITIALS C.B., WEIGHING 5.6 KG, AND IDENTIFIED AS BLACK OR AFRICAN AMERICAN. THERE WERE A PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832840 ↗
• MalfunctionApr 9, 2026Crack

  EVENT OCCURRED REGARDING A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT TWO SEPARATE ALARIS LIPID FILTERS WERE FOUND CRACKED AT THE LUER LOCK ATTACHMENT SITE. BOTH FILTERS WERE REMOVED FROM THE IV TUBING, AND THE TUBING WAS RE-PRIMED WITH NEW FILTERS. THE PATIENT INVOLVED IN THE EVENT WAS A 9-YEAR-OLD MALE WITH INITIALS C.B., WEIGHING 5.6 KG, AND IDENTIFIED AS BLACK OR AFRICAN AMERICAN. THERE WERE A PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832837 ↗
• MalfunctionJul 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT A FILTER WAS LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680419 ↗
• MalfunctionJun 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WAS FOUND TO HAVE EXPERIENCED A DISCONNECT AT THE POINT OF THE FILTER. THERE WAS NO PATIENT HARM REPORTED. THE INITIAL REPORTER INDICATED THAT THE EVENT OCCURRED TWICE; HOWEVER, NO ADDITIONAL INFORMATION WAS GIVEN PERTAINING TO THE ADDITIONAL INSTANCES. A SEARCH OF THE COMPLAINT DATABASE SHOWED NO PRIOR REPORT OF THESE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340974 ↗
• MalfunctionJun 23, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A LUER LOCK CAP FROM A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER REPORTEDLY CRACKED AND LEAKED LIQUIDS NEAR THE CONNECTION SITE DURING PATIENT USE. THE ITEM WAS PULLED FROM PATIENT USE. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311576 ↗
• MalfunctionApr 22, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED FILTER ISSUES ON THE PRODUCT THAT LEAD TO LEAKAGE OF AN UNSPECIFIED FLUID AND/OR BREAKAGE. THEY HAVE HAD AT LEAST 9 REPORTS IN THE PAST MONTH. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM BUT THERE WAS A DELAY IN CARE AS TREATMENTS WERE STOPPED TO CHANGE OUT FILTER/LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886635 ↗
• MalfunctionMar 24, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE LIPID TUBING WAS FOUND TO BE SNAPPED OFF AT THE FILTER; THE LINE WAS STILL INTACT AT LUMEN. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT. THERE WAS A DELAY IN THERAPY AS FILTER TUBING HAD TO BE CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21681346 ↗
• MalfunctionMar 24, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE PATIENT WAS BEING HELD BY THE MOTHER, AND SHE FELT WETNESS WHILE HOLDING PATIENT. WHEN BOTH PARENTS LOOKED FOR THE SOURCE OF THE WETNESS, THEY FOUND THE LIPID FILTER HAS DISCONNECTED/SEPARATED. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO HARM AS A CONSEQUENCE OF THIS EVENT. THERE WAS A DELAY IN THERAPY AS FILTER TUBING HAD TO BE CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677826 ↗
• MalfunctionMar 24, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE LIPID TUBING FILTER BROKE AT THE FILTER LOCATION WITH NO FORCE APPLIED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM; BUT A DELAY IN THERAPY AS FILTER TUBING HAD TO BE CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677632 ↗
• MalfunctionFeb 26, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THERE WAS A LEAK IN THE LIPID TUBING FILTER, RN CAME AND CHECK THE FILTER AND NOTICE THAT THE FILTER IS BROKEN AND THE TUBING CONNECTED TO IT. ANOTHER REPORT STATED THAT RN NOTED THAT LIPID TUBING HAD BROKEN OFF FROM THE FILTER AND WITH NO PRESSURE IN THE LINE FROM LIPIDS BLOOD WAS LEAKING OUT THE BROKEN TUBING, SAMPLE WAS SAVED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 2 OF 2 OCCURRENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21471789 ↗
• MalfunctionFeb 26, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THERE WAS A LEAK IN THE LIPID TUBING FILTER, RN CAME AND CHECK THE FILTER AND NOTICE THAT THE FILTER IS BROKEN AND THE TUBING CONNECTED TO IT. ANOTHER REPORT STATED THAT RN NOTED THAT LIPID TUBING HAD BROKEN OFF FROM THE FILTER AND WITH NO PRESSURE IN THE LINE FROM LIPIDS BLOOD WAS LEAKING OUT THE BROKEN TUBING, SAMPLE WAS SAVED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 1 OF 2 OCCURRENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21471753 ↗
• MalfunctionFeb 26, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT LIPID TUBING DISCONNECTED AT THE FILTER AREA. ANOTHER REPORT STATED THAT LIPID TUBING DISCONNECTED FROM THE SITE OF FILTER CONNECTION. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 2 OF 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471740 ↗
• MalfunctionFeb 26, 2025Material Separation; Material Separation

  THE EVENT INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT LIPID TUBING DISCONNECTED AT THE FILTER AREA. ANOTHER REPORT STATED THAT LIPID TUBING DISCONNECTED FROM THE SITE OF FILTER CONNECTION. THERE WAS PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY. THIS CAPTURES 1 OF 2 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471738 ↗
• MalfunctionNov 8, 2024Disconnection; Disconnection

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER THAT EXPERIENCED SEPARATION DURING INFUSION. THERE WAS PATIENT INVOLVEMENT. THIS IS 2 OF 2 REPORTS. THE REPORT STATES THAT 2 LIPID TUBINGS WAS DETACHED. THE ISSUE WAS TUBING DETACHED AT THE FILTER. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS IN USE AND INFUSING LIPIDS ON A PATIENT. WHEN CUSTOMER ASKED "WAS ANYONE HARMED AS A RESULT OF EVENT?" SHE ANSWERED THAT "TUBING WAS CONNECTED TO A CENTRAL LINE INCREASING THE CHANCES FOR INFECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642426 ↗
• MalfunctionNov 8, 2024Disconnection; Disconnection

  A COMPLAINT WAS RECEIVED WITH REGARDS TO A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER THAT EXPERIENCED SEPARATION DURING INFUSION. THERE WAS PATIENT INVOLVEMENT. THIS IS 1 OF 2 REPORTS. THE REPORT STATES THAT 2 LIPID TUBINGS WAS DETACHED. THE ISSUE WAS TUBING DETACHED AT THE FILTER. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS IN USE AND INFUSING LIPIDS ON A PATIENT. WHEN CUSTOMER ASKED "WAS ANYONE HARMED AS A RESULT OF EVENT?" SHE ANSWERED THAT "TUBING WAS CONNECTED TO A CENTRAL LINE INCREASING THE CHANCES FOR INFECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642216 ↗
• MalfunctionNov 8, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED WITH REGARDS TO 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER EXPERIENCED BREAKAGE AND LEAKAGE. THE REPORT STATES THAT ¿UPON ASSESSMENT, NOTED LIPID FILTER BROKEN. TUBING INFUSING DIRECTLY TO BED. FILTER STILL ATTACHED TO Y-CONNECTOR ON CVC; BACKFLOW OF BLOOD NOTED IN FILTER. TPN STILL INFUSING ON OTHER PORT OF Y-CONNECTOR. BOTH TPN AND IL INFUSIONS STOPPED IMMEDIATELY; TUBING REMOVED AND DISCARDED. CAP CHANGED WITH PICL AND LINE HEPARIN-LOCKED.¿ THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT. ADDITIONALLY, THE INITIAL REPORTER ASKED THE CUSTOMER IF THERE WERE ANY PATIENTS WERE HARMED/AFFECTED AND THE CUSTOMER ANSWERED THAT "TPN HAD TO BE STOPPED AND THE LIPIDS DISCARDED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641540 ↗
• MalfunctionAug 20, 2024Disconnection; Disconnection

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THE NURSE NOTICED A SOILED BLANKET AND UPON FURTHER INVESTIGATION, THE TUBING CONNECTED TO THE ACTUAL FILTER WAS NOT INTACT (WAS DISCONNECTED). THE CUSTOMER STATED THAT THE ISSUE WAS IDENTIFIED WITH SUPPLY ITEM. THE NURSING DEPARTMENT WAS AFFECTED BY THE ISSUE. THE CUSTOMER STATED THAT A MIDAS INCIDENT REPORT WAS CREATED AND ASSIGNED THE MIDAS CASE NUMBER (B)(4). THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM/ADVERSE EVENT, AND UNKNOWN DELAY OF THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000805 ↗
• MalfunctionAug 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT LIPIDS WERE PRIMED THROUGH TUBING AND LIPID FILTER AND CONNECTED TO PATIENT. THE NURSE NOTED BLOOD BACK FLOWING THROUGH LIPID FILTER AND OOZING OUT THE FRONT OF THE FILTER. THE FILTER AND TUBING WERE CHANGED AND RECONNECTED TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934147 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER WHERE THE CUSTOMER STATED THAT THEY HAD MANY ISSUES WITH SEPARATIONS. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624883 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964435. One submission often covers many models, so check the product and lot details in each record.

• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration Sets with drip chambers
• Z-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-0154-2026 · Oct 2, 2025 · Open, Classified
  IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B
• Z-1721-2022 · Aug 1, 2022 · Open, Classified
  6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
• Z-0958-2021 · Dec 2, 2020 · Terminated
  154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides ac
• Z-0957-2021 · Dec 2, 2020 · Terminated
  7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro
• Z-0955-2021 · Dec 2, 2020 · Terminated
  60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pr
• Z-0956-2021 · Dec 2, 2020 · Terminated
  60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl
• Z-0228-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709089904(17)250101(30)25(10)4713954.
• Z-0225-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705.
• Z-0189-2021 · Jul 6, 2020 · Terminated
  9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(0
• Z-0226-2021 · Jul 6, 2020 · Terminated
  112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088518(17)241101(30)25(10)4475764 (01)108
• Z-0247-2021 · Jul 6, 2020 · Terminated
  7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(17)250101(30)50(10)4572133. The Intravasc
• Z-0195-2021 · Jul 6, 2020 · Terminated
  109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotati
• Z-0258-2021 · Jul 6, 2020 · Terminated
  112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case

…and 173 more.