ICU Medical AM3090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709080799), received between Sep 27, 2022 and Apr 22, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionApr 22, 2026Break

  THE EVENT INVOLVED A 10" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK. IT WAS REPORTED THAT THE NURSE IN THE ROOM SEES BLOOD RISING IN THE TUBING OF THE CENTRAL LINE. SHE REALIZED THAT THERE WAS A BROKEN PORT (COMPLETELY TORN OFF) ON A THREE-PORT ICU MEDICAL THAT WAS IN NON-STOCK. THERE WAS PATIENT INVOLVEMENT. BLOOD PRESSURE DROPS BUT PATIENT WAS FINE. NO HARM WAS REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24958601 ↗
• MalfunctionJan 26, 2026Crack

  THE EVENT INVOLVED A 10" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK WHERE THE CUSTOMER REPORTED THAT THE PORT BROKE OFF WHILE IN USE ON A PATIENT. HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180865 ↗
• MalfunctionDec 28, 2023Break; Crack; Fluid/Blood Leak; Break; Crack; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 10" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK. THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WHEREIN A PORT ON THE MANIFONIFOLD WAS BROKEN AND CAUSED MEDICATION (VASPORESSORS) TO NOT BE DELIVERED AS INTENDED TO THE PATIENT; THE PATIENT'S BLOOD PRESSURE DROPPED (SYSTOLIC IN THE 70S AND MEAN ARTERIAL PRESSURE WAS IN THE 40S). THERE WAS A DELAY IN THERAPY AS THE VASOPRESSOR MEDICATIONS WERE RUNNING THROUGH THIS PORT AND WERE NOT REACHING PATIENT SINCE THEY WERE LEAKING OUT OF THE BROKEN SEAM. THE INTERVENTION WAS REARRANGING THE INFUSION TO A DIFFERENT DELIVERY SYSTEM. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18412798 ↗
• InjurySep 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A 10" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK BROKE OFF THE LEFT FEMORAL CENTRAL ACCESS WHEN THE REGISTERED NURSE (RN) ATTEMPTED TO DISCONNECT A MIDAZOLAM INFUSION IN ORDER TO CHANGE THE SYRINGE/TUBING. THIS CAUSED BACK UP OF BLOOD FROM THE PATIENT INTO THE MULTI CONNECTOR. THE PATIENT HAD NOREPINEPHRINE INFUSING AT THE TIME AND SUBSEQUENTLY HAD A DROP IN BLOOD PRESSURE (MAP 50 MMHG). THE RN ADMINISTERED A BOLUS OF NOREPINEPHRINE. THE INITIAL REPORTER ENTERED THE ROOM AND ASSISTED WITH TRANSFERRING A NOREPINEPHRINE INFUSION DIRECTLY TO THE ACCESS PORT AS AN INCREASE IN INFUSION WAS REQUIRED. A NEW MULTI-CONNECTOR WAS PRIMED AND ATTACHED FOR ALL INFUSIONS. THE CARRIER FLUID REQUIRED TO BE INCREASED TEMPORARILY TO FACILITATE THE INFUSION OF VASOACTIVE MEDS. ONCE THE PATIENT¿S BLOOD PRESSURE (BP) STABILIZED, THE RN WAS ABLE TO RETURN NOREPINEPHRINE AND CARRIER FLUIDS TO PREVIOUS RATES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 15490164 ↗

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-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-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-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-0233-2021 · Jul 6, 2020 · Terminated
  139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)1088
• 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-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-0211-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.UDI:(01)
• Z-0194-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(0
• Z-0203-2021 · Jul 6, 2020 · Terminated
  8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30
• 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

…and 173 more.