ICU Medical A1145Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709070103), received between Oct 11, 2023 and May 31, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 12" SMALLBORE HEXAFUSE EXT SET W/6 MICROCLAVE CLEAR, NANOCLAVE (RED RING), 6 CHECK VALVES, 7 CLAMPS (GREEN, 2 YELLOW, BLUE, LIGHT GREEN, 2 WHITE) LUER LOCK THAT EXPERIENCED LEAKAGE DURING USE. THE REPORTER STATED THAT THE RN WAS HANGING NEW TPN/SMOF/FENTANYL/PRECEDEX INTO PICC LINE. AFTER HANGING THE LINES AND BEFORE FLUIDS WERE STARTED, THIS RN NOTICED THAT FENTANYL SYRINGE WAS CLOUDY AND NOTICED TUBING WAS BACKED WITH SMOF LIPIDS REGARDLESS OF THE HEXSET BEING CLAMPED. THIS RN THEN NOTICED THAT SMOF WAS LEAKING INTO OTHER AREAS OF THE HEXSET AND FLUIDS WERE NOT STARTED AS RESULT. NEW BAGS WERE ORDERED AND HUNG. PATIENT INVOLVED IS A 0.05-YEAR-OLD MALE. NO OTHER DEVICES BEING USE ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSE OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120419 ↗
• MalfunctionDec 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 12" SMALLBORE HEXAFUSE EXT SET W/6 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 6 CHECK VALVES, 7 CLAMPS (GREEN, 2 YELLOW, BLUE, LIGHT GREEN, 2 WHITE) LUER LOCK WHERE IT WAS REPORTED THAT THE HEX SET WAS FOUND LEAKING ABOVE CLAVE. BED SATURATED WITH TOTAL PARENTERAL NUTRITION (TPN) FLUID THAT WAS RUNNING THROUGH THE LINE. THE DEFECT WAS IN HEX SET. IT WAS NOT A SINGLE USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. THE DEVICE WAS IN USE FOR PATIENT CARE. NO OTHER DEVICE BEING USED ON THE PATIENT AT THE TIME OF EVENT THAT MAY CAUSE OR CONTRIBUTED TO THE EVENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20884809 ↗
• MalfunctionDec 14, 2023Disconnection; Material Separation; Disconnection; Material Separation

  THE EVENT INVOLVED A 12" SMALLBORE HEXAFUSE EXT SET W/6 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 6 CHECK VALVES, 7 CLAMPS (GREEN, 2 YELLOW, BLUE, LIGHT GREEN, 2 WHITE) LUER LOCK. IT WAS REPORTED THE PRECEDEX BECAME DISCONNECTED FROM EXTENSION SET AND WAS UNDETECTED. PATIENT STARTED HAVING SYMPTOMS AFTER NOT RECEIVING THE CONTINUOUS MEDICATION. BOLUS OF VERSED WAS GIVEN TO MINIMIZE WITHDRAWAL SYMPTOMS UNTIL A NEW BAG WAS RECEIVED. I'M NOT SURE HOW MUCH TIGHTER THE CONNECTIONS CAN BE BUT SOMEHOW, THEY ARE ABLE TO COME LOOSE WITHOUT EVEN MOVING THE PATIENT. MISSING MICROCLAVE ON END OF TUBING.THE MICROCLAVE MISSING FROM END OF SET- LIKELY A LACK OF BONDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325760 ↗
• MalfunctionOct 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 12" SMALLBORE HEXAFUSE EXT SET W/6 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 6 CHECK VALVES, 7 CLAMPS (GREEN, 2 YELLOW, BLUE, LIGHT GREEN, 2 WHITE) LUER LOCK. IT WAS REPORTED THAT DURING AN INFUSION, LEAKING WAS NOTED NEAR NANOCLAVE ON LEG WITH WHITE AND YELLOW CLAMPS. IT APPEARS THAT THIS MAY BE DUE TO ISSUE WITH BONDING. THE OPEN FLUID PATHWAY INCREASES RISKS FOR CATHETER ASSOCIATED BLOOD STREAM INFECTION. THERE WAS PATIENT INVOLVEMENT HOWEVER, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912199 ↗

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-3163-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3157-2026 · May 12, 2026 · Open, Classified
  IV Non-Dedicated Gravity Administration 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-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-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-0207-2021 · Jul 6, 2020 · Terminated
  13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)
• 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-0262-2021 · Jul 6, 2020 · Terminated
  8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(17)250101(30)50(10)4605676. CLAVE Neutron i
• Z-0244-2021 · Jul 6, 2020 · Terminated
  128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887
• Z-0242-2021 · Jul 6, 2020 · Terminated
  11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(
• Z-0221-2021 · Jul 6, 2020 · Terminated
  83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. UDI:(01)10887709089508(17)250101(30)25(10)45
• Z-0190-2021 · Jul 6, 2020 · Terminated
  9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053004(17)250101(30)50

…and 173 more.