ICU Medical 011-AM3090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619091729), received between Sep 5, 2025 and Nov 20, 2025 — classified as 3 malfunctions.

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

• MalfunctionNov 20, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  AN EVENT INVOLVED A 25 CM (10") EXT SET W/3-PORT NANOCLAVE MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK. IT WAS REPORTED THAT THE RIGHT VALVE WAS IN GOOD CONDITION, THE MIDDLE VALVE WAS SUNKEN, AND THE LEFT VALVE WAS SLIGHTLY SUNKEN. THE RIGHT VALVE WAS USED FOR CONTINUOUS INFUSION. THE MIDDLE VALVE, WHICH HAD A RED CAP, WAS FOUND BROKEN. DURING AN MRI ON (B)(6) 2025, WHILE ADMINISTERING A BOLUS MEDICATION, THE MIDDLE VALVE WAS OBSERVED TO HAVE SUNK IN. THE RED CAP WAS LATER ADDED TO INDICATE THE ROUTE WAS OUT OF ORDER (NOT CAUSED BY THE CAP). ON (B)(6) 2025, THE PATIENT RETURNED TO THE WARD; THE RED CAP SIGNIFIED THE VALVE WAS UNUSABLE. A BOLUS MEDICATION WAS THEN ADMINISTERED THROUGH THE LEFT VALVE, WHICH HAD SUNK DEEPER AND LEAKED MEDICATION OUTWARD. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613494 ↗
• MalfunctionSep 5, 2025Separation Problem; Separation Problem

  EVENT OCCURRED REGARDING A 25 CM (10") EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK WHERE THE REPORTER STATED THAT THE "INFUSION LINE THAT SHOULD BE CONNECTED TO THE MANIFOLD WAS ON THE FLOOR, AS ITS MEDIAL PORT WAS DETACHED FROM THE BASE." THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983686 ↗
• MalfunctionSep 5, 2025Separation Problem; Separation Problem

  THE EVENT INVOLVED A 25 CM (10") EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK WHERE THE CUSTOMER REPORTED THAT WHEN THE NURSE ENTERED THE ROOM, HE NOTICED THAT THE INFUSION LINE THAT SHOULD BE CONNECTED TO THE MANIFOLD WAS ON THE FLOOR, AS ITS MEDIAL PORT WAS DETACHED FROM THE BASE. THE PRODUCT WAS IN SUE FOR ONE DAY, IT HAD NOT BEEN REPROCESSED OR RE-STERILIZED PRIOR TO USE. PARACETAMOL WAS BEING USED WITH THE DEVICE; THE EVENT OCCURRED DURING PATIENT USE AND THERE WAS DELAY IN THERAPY BUT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976817 ↗

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-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-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-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-0191-2021 · Jul 6, 2020 · Terminated
  5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101
• 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-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-0196-2021 · Jul 6, 2020 · Terminated
  7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)2
• Z-0254-2021 · Jul 6, 2020 · Terminated
  22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051967(17)250101(30)50(10)4605591; (01)10
• Z-0228-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709089904(17)250101(30)25(10)4713954.

…and 173 more.