ICU Medical AC235Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887709122062), received between May 9, 2024 and Feb 2, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Disconnection; Fluid/Blood Leak; Fracture

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 14"(36CM)APPX3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿ STOPCOCK(RED RING). THE PATIENT REPORTEDLY DISCONNECTED FROM THE DEVICE TUBING. UPON ENTERING THE ROOM, THE NURSE NOTICED THAT THE TUBING HAD SNAPPED IN HALF. THE PATIENT HAD UNSPECIFIED CHEMOTHERAPY GOING AT THE TIME IN THE LAB PORT. THE TUBING THAT SNAPPED WAS A TRIFUSE CONNECTOR ON THE SIDE CLOSEST TO THE PATIENT, BENEATH THE LAB PORT. THERE WAS CHEMOTHERAPY EXPOSURE TO THE INVOLVED PATIENT.

  Patient problems: Chemical Exposure

  MAUDE report 24239769 ↗
• MalfunctionJul 17, 2025Break; Material Separation; Break; Material Separation

  A COMPLAINT WAS RECEIVED REGARDING A 14"(36CM) APPX 3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿ STOPCOCK(RED RING) THAT EXPERIENCED DISCONNECTION DURING USE. THE REPORT STATED "RN WAS ASSESSING THE PATIENT AND NOTICED THAT THE TUBING HAD DISCONNECTED FROM THE PURPLE LUMEN. THE TRIFUSE HAD BROKEN AT THE AREA CLOSED TO THE PATIENT CONNECTION. THE MALE CONNECTION HAD BROKEN OFF FROM THE REST OF THE TRIFUSE AND WAS STILL CONNECTED TO THE PATIENT. THE PATIENT MOTHER REPORTED THAT THIS HAS HAPPENED A FEW OTHER TIMES". THERE WAS PATIENT INVOLVEMENT AND NO INJURIES OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538532 ↗
• MalfunctionDec 3, 2024Material Separation; Material Separation

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 14"(36CM)APPX3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿ STOPCOCK(RED RING) WHERE THE REPORTER STATED THAT THEY HAD A FAILED DEVICE EVENT ASSOCIATED WITH SET EXT TRIFUSE 14IN W/3. THE PATIENT WAS PLAYING ON THE PLAYMAT ON THE FLOOR. PATIENT'S MOM CALLED THE RN, AND THE RN WALKED IN AND SAW THE TRIFUSE EXTENSION SET WAS BROKEN OFF AND DISCONNECTED FOR THE LINE. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834786 ↗
• MalfunctionJul 1, 2024Disconnection; Disconnection

  THE EVENT INVOLVED A 14"(36CM)APPX3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿ STOPCOCK(RED RING) AND OCCURRED ON AN UNSPECIFIED DATE.IT WAS REPORTED THAT THE MALE ADAPTOR COLLAR APPEARS TO HAVE DISCONNECTED. THIS HAPPENED WHILE BEING TRANSFERRED TO BED. SAMPLES ARE AVAILABLE FOR RETURN. THERE WAS PATIENT INVOLVEMENT, AND NO INJURIES OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652547 ↗
• MalfunctionMay 9, 2024Material Separation; Material Separation

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 14"(36CM)APPX3.0ML, TRIFUSE EXT SET W/3 MICROCLAVE CLEAR¿,3 BCV,4-WAY NANOCLAVE¿ STOPCOCK(RED RING). THE CUSTOMER REPORTED THAT THE THE MALE CONNECTOR DETACHED FROM THE END OF THE TRI-FUSE DEVICE. THERE WAS NO INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281520 ↗

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-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-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-0216-2021 · Jul 6, 2020 · Terminated
  54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, n
• Z-0206-2021 · Jul 6, 2020 · Terminated
  60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit p
• Z-0184-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI: (01)10887709051031(
• Z-0256-2021 · Jul 6, 2020 · Terminated
  149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;
• Z-0214-2021 · Jul 6, 2020 · Terminated
  99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515
• Z-0200-2021 · Jul 6, 2020 · Terminated
  12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)45727
• 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

…and 173 more.