ICU Medical AM3014Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887709086227), received between Apr 1, 2022 and Mar 11, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Disconnection” (4 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.

• MalfunctionMar 11, 2026Separation Problem

  EVENT OCCURRED REGARDING EXT SET WITH 3 PORT NANOCLAVE MANIFOLD, WHERE IT WAS REPORTED THAT THE PRODUCT BROKE OFF FROM PATIENT'S CATHETER WHILE MEDICATIONS WERE RUNNING. PATIENT HARM IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569756 ↗
• MalfunctionMay 26, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 26" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, 2 MICROCLAVE® CLEAR, CLAMP, LUER LOCK WHERE IT WAS REPORTED THAT THE RN NOTED THE PATIENT¿S BLOOD PRESSURE DECREASED SIGNIFICANTLY WHILE SHE WAS ASSISTING ANOTHER PATIENT. UPON ARRIVAL AT THE BEDSIDE, THE MANIFOLD PIECE HAD DISCONNECTED FROM THE MANIFOLD, CAUSING THE VASOPRESSOR TO SUBSEQUENTLY INTO THE FLOOR INSTEAD OF THE PATIENT. THE PATIENT COMPLAINED OF UNWELL FEELING DUE TO A SIGNIFICANT DROP IN BLOOD PRESSURE DUE TO UNINTENDED INTERRUPTION OF MEDICATION. THERE WAS A PATIENT INVOLVEMENT BUT NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518604 ↗
• MalfunctionMay 26, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 26" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, 2 MICROCLAVE® CLEAR, CLAMP, LUER LOCK WHERE IT WAS REPORTED THAT THE RN NOTED THE PATIENT¿S BLOOD PRESSURE DECREASED SIGNIFICANTLY WHILE SHE WAS ASSISTING ANOTHER PATIENT. UPON ARRIVAL AT THE BEDSIDE, THE MANIFOLD PIECE HAD DISCONNECTED FROM THE MANIFOLD, CAUSING THE VASOPRESSOR TO SUBSEQUENTLY INTO THE FLOOR INSTEAD OF THE PATIENT. THE PATIENT COMPLAINED OF UNWELL FEELING DUE TO A SIGNIFICANT DROP IN BLOOD PRESSURE DUE TO UNINTENDED INTERRUPTION OF MEDICATION. THERE WAS A PATIENT INVOLVEMENT BUT NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518589 ↗
• MalfunctionMay 26, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  UPDATE: A MEDWATCH REPORT WAS RECEIVED ON 20-JUL-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518284 ↗
• MalfunctionApr 1, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 26" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, 2 MICROCLAVE® CLEAR, CLAMP, LUER LOCK WHERE IT WAS REPORTED THAT THE RN NOTED THE PATIENT¿S BLOOD PRESSURE DECREASED SIGNIFICANTLY WHILE SHE WAS ASSISTING ANOTHER PATIENT. UPON ARRIVAL AT THE BEDSIDE, THE MANIFOLD PIECE HAD DISCONNECTED FROM THE MANIFOLD, CAUSING THE VASOPRESSOR TO SUBSEQUENTLY INTO THE FLOOR INSTEAD OF THE PATIENT. THE PATIENT COMPLAINED OF UNWELL FEELING DUE TO A SIGNIFICANT DROP IN BLOOD PRESSURE DUE TO UNINTENDED INTERRUPTION OF MEDICATION. THERE WAS A PATIENT INVOLVEMENT BUT NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978115 ↗

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-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-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-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-0255-2021 · Jul 6, 2020 · Terminated
  148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intrav
• Z-0229-2021 · Jul 6, 2020 · Terminated
  78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The I
• Z-0186-2021 · Jul 6, 2020 · Terminated
  7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)
• 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-0227-2021 · Jul 6, 2020 · Terminated
  142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948
• 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
• 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

…and 173 more.