ICU Medical AC135Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00887709124417), received between Feb 7, 2025 and Sep 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “No Flow” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

187 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.

Recalls naming this device

1. May 12, 2026Class IIOpen, Classified

   Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

   Z-3163-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937017 ↗
• MalfunctionSep 29, 2026No Flow

  Additional used device has been received for the investigation, and the event involved a 120" (305 cm) Appx 15.8 ml, 15 Drop Admin Set with 3 Clave Clear, NanoClave Stopcock, 2 Check Valves, Spin Luer, 2 Ext. It was reported that set was primed successfully but would not deliver fluid when connected to the patient¿s catheter. Saline was involved. There was no delay in therapy because another set was promptly primed and used. There was patient involvement and no patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936640 ↗
• MalfunctionSep 29, 2026No Flow

  Additional used device has been received for the investigation, and the event involved a 120" (305 cm) Appx 15.8 ml, 15 Drop Admin Set with 3 Clave Clear, NanoClave Stopcock, 2 Check Valves, Spin Luer, 2 Ext. It was reported that set was primed successfully but would not deliver fluid when connected to the patient¿s catheter. Saline was involved. There was no delay in therapy because another set was promptly primed and used. There was patient involvement and no patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936392 ↗
• MalfunctionSep 29, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936106 ↗
• MalfunctionJul 29, 2026No Flow

  The event involved a 120" (305 cm) Appx 15.8 ml, 15 Drop Admin Set w/3 Clave¿ Clear, NanoClave¿ Stopcock, 2 Check Valves, Spin Luer, 2 Ext It was reported that when the nurse spiked a bag and the tubing wouldn't prime. The nurse used 2 more sets of tubing. The tubing primed the next time however the fluid would not drip once connected to the patient. No noted visible damage or defects. The fluid administered was lactated ringers. The event occurred during patient use. There was a patient involvement but no reported patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50064634 ↗
• MalfunctionJul 20, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25876512 ↗
• MalfunctionMay 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 120" (305 CM) APPX 15.8 ML, 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK, 2 CHECK VALVES, SPIN LUER, 2 EXT WHERE IT WAS REPORTED THAT ONE OF THE SETS HAD SOME SORT OF BLACK GROWTH IN THE DRIP CHAMBER. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054993 ↗
• MalfunctionMay 20, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 120" (305 CM) APPX 15.8 ML, 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK, 2 CHECK VALVES, SPIN LUER, 2 EXT. IT WAS STATED IN THE REPORT THAT THE LINE SEEMED TO PRIME FINE BUT THEN FLOW STOPPED WHEN IT WAS CONNECTED TO IV. IT COULD HAVE ALSO BEEN RELATED TO THE LOWER BACKCHECK VALVE NOT FULLY ¿POPPING¿ OPEN. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN PATIENT HARM AND UNKNOWN DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054922 ↗
• MalfunctionFeb 13, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 120" (305 CM) APPX 15.8 ML, 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK, 2 CHECK VALVES, SPIN LUER, 2 EXT WHERE THE REPORTER STATED THAT THE CUSTOM ANESTHESIA SET WHERE THE LINE PRIMES FINE AND WILL ADMINISTER FLUID, SUDDENLY STOPPED WORKING 1-2 HOURS IN. IT WAS VERY PROBLEMATIC AS THEY HAVE TO PAUSE PATIENT CARE AND CHANGE OUT THE LINE, CAUSING A PAUSE IN FLUID DELIVERY (WHICH IF ANESTHESIA DRUGS ARE CURRENTLY BEING ADMINISTERED COULD CAUSE A MAJOR ISSUE). THERE WAS PATIENT INVOLVEMENT REPORTED BUT UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21380887 ↗
• MalfunctionFeb 7, 2025No Flow; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334290 ↗

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-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-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-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-0249-2021 · Jul 6, 2020 · Terminated
  6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UDI:(01)10887709079877(17)250101(30)50(10)4584753;(01)108877090
• 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
• Z-0188-2021 · Jul 6, 2020 · Terminated
  10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri-Connector, NanoClave T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouche
• Z-0187-2021 · Jul 6, 2020 · Terminated
  7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108877090510
• Z-0223-2021 · Jul 6, 2020 · Terminated
  26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658. The I
• 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-0215-2021 · Jul 6, 2020 · Terminated
  29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case. UDI:(01)10840619082533(17)250101(30)50(10)4605138. The Intravascular Admi
• Z-0183-2021 · Jul 6, 2020 · Terminated
  6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10887709051024(17)250101(30)50(10)

…and 172 more.