ICU Medical, Inc. AM3130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709128224), received between Jul 29, 2025 and Aug 29, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Air/Gas in Device; Air/Gas in Device

  EVENT OCCURRED REGARDING A 129" (328 CM) APPX 24.3 ML 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, 4-WAY STOPCOCK, 3 CHECK VALVES, 3-PORT NANOCLAVE¿ MANIFOLD, SPIN LUER, 2 EXT WHERE THE REPORT STATED THAT "THE LINE WAS CLAMPED WITH THE ROLLER CLAMP, AND THE STOP COCK WAS TURNED TO OFF. THE IVF CONTINUED TO DRIP AND RUN DRY, PULLING A LARGE AIR BUBBLE EXTENDING THE LENGTH OF THE TUBING." THERE WAS PATIENT INVOLVEMENT, BUT NO HARM WAS CAUSED BY THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929112 ↗
• MalfunctionJul 29, 2025Crack; Crack

  THE EVENT INVOLVED A 129" (328 CM) APPX 24.3 ML 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, 4-WAY STOPCOCK, 3 CHECK VALVES, 3-PORT NANOCLAVE¿ MANIFOLD, SPIN LUER, 2 EXT WHERE THE CUSTOMER REPORTED THAT WHILE IN THE PROCESS OF DELIVERING PROPOFOL THROUGH ONE OF THE PORTS ON THE DEVICE, MANIFOLD BROKE OFF WHILE TIGHTENING THE SYRINGE ON. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650479 ↗

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-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-0198-2021 · Jul 6, 2020 · Terminated
  107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(
• 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-0246-2021 · Jul 6, 2020 · Terminated
  40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709014531(17)250101(30)50
• Z-0240-2021 · Jul 6, 2020 · Terminated
  11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI:(01)10887709088354(17)250101(30)50(10)4557643. The Intrava
• Z-0253-2021 · Jul 6, 2020 · Terminated
  60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040264(17)250201(30)50(10)4714442. The Intravascular
• 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-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

…and 173 more.