ICU Medical AC136Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887709125766), received between Sep 7, 2025 and Feb 16, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Separation Problem; Air/Gas in Device

  THE EVENT WAS REPORTED VIA A USER FACILITY MANDATORY MEDWATCH REPORT NUMBER (B)(4). THE DATE OF THE EVENT WAS AN UNKNOWN DATE IN JUNE 2025 AND INVOLVED A 60" (152 CM) APPX 2.2 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK, 0.2 MICRON FILTER, SPIN LUER WHERE THE CUSTOMER REPORTED THAT SMALL AIR BUBBLES IN TUBING. IT WAS REPORTED THAT THE NURSE WAS PRIMING NEONATAL INTENSIVE CARE UNIT (NICU) SPECIFIC DRIP TUBING FOR NEW MORPHINE GTT; THE NURSE HAD CONNECTED TUBING TO PORT ON UMBILICAL VENOUS CATHETER (UVC) WITH A BLUE CLAMP, AND THEN NOTICED SOME SMALL AIR BUBBLES STILL IN TUBING. THE NURSE WENT TO DISCONNECT FROM THE UVC PORT TO RE-PRIME TUBING AND WHEN ATTEMPTING TO DISCONNECT, THE TOP PIECE OF THE LUER LOCK OF THE DRIP TUBING SNAPPED OFF, LEAVING THE INTERNAL PIECE OF THE LUER LOCK CONNECTED TO THE UVC. THE NURSE HAD DIFFICULTY ATTEMPTING TO UNSCREW THE INTERNAL PORTION; THE NEONATAL NURSE PRACTITIONER (NNP) WAS SUCCESSFUL AT UNSCREWING. MORPHINE GTT WAS THEN PRIMED USING REGULAR MED TUBING AND FILTER AS THERE HAD BEEN ONGOING REPORTS OF ISSUES WITH THE DRIP TUBING. THERE WAS PATIENT INVOLVEMENT (INFANT,) BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349344 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED WITH AN ATTACHED USER FACILITY MANDATORY MEDWATCH REPORT NUMBER (B)(4) WITH REGARDS TO A SMALLBORE EXT SET ALLEGING A LEAK OCCURRED DURING PATIENT USE ON AN UNSPECIFIED DATE IN (B)(6) 2025. IT WAS REPORTED THAT THE PRECEDEX DRIP WAS FOUND TO BE LEAKING AT THE STOPCOCK SITE. LIPIDS WERE BACKING UP AS WELL. THERE WAS PATIENT INVOLVEMENT (INFANT) AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326245 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) AND INVOLVED A 60" (152 CM) APPX 2.2 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK, 0.2 MICRON FILTER, SPIN LUER. THE CUSTOMER REPORTED THAT AT 3AM, TWO NURSES NOTICED THAT THE GTT TUBING THAT WAS INFUSING MIDAZOLAM CONTINUOUSLY WAS WET/LEAKING AT THE CONNECTION HUB RIGHT NEXT TO THE STOPCOCK/PROXIMAL TO THE PATIENT. THE DOCTOR WAS NOTIFIED AND S/HE WAS ABLE TO MANUALLY TIGHTEN THE CONNECTION A FEW CENTIMETERS AWAY FROM STOPCOCK TO STOP THE MEDICATION FROM LEAKING. THE GTT TUBING HAD BEEN PRIMED AND HUNG AT 2000 AND WAS NOT NOTED TO BE LEAKING DURING THE PRIMING PROCESS. THE CUSTOMER SAID THAT THEY CANNOT BE SURE WHEN THE TUBING STARTED TO LEAK AS THE SYRINGE VOLUME WAS APPROPRIATELY DECREASING AND THE PUMP VOLUMES CORRELATED WITH THE VOLUME THAT WAS SUPPOSED TO BE DELIVERED. THERE WAS PATIENT INVOLVEMENT (INFANT) AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308396 ↗
• MalfunctionJan 28, 2026

  MULTIPLE EVENTS HAVE BEEN DOCUMENTED REGARDING MALFUNCTION OF THIS IV TUBING. THESE EVENTS HAVE BEEN REPORTED TO THE COMPANY REPRESENTATIVE AND ARE LISTED UNDER COMPLAINT NUMBERS [REDACTED], [REDACTED], [REDACTED]. THE NICU [NEONATAL INTENSIVE CARE UNIT] TEAM IS REQUESTING TO HAVE FURTHER INFORMATION RE: THE COMPANY'S FINDINGS SO THEY CAN START TO RE-ORDER THIS PRODUCT. [REDACTED]: ON [REDACTED], RN NOTED THE IV GTT [DRIP] TUBING USED TO ADMINISTER FENTANYL TO THE PATIENT TO HAVE INCREASING VOLUME ON THE SYRINGE PUMP. THE SYRINGE PUMP ALARMED "OCCLUSION" AT 1300, AND THE RN NOTED THERE TO BE CLEAR DRIPS COMING OFF OF THE OUTSIDE OF THE IV TUBING NEAR THE STOPCOCK ON THE GTT TUBING. THE MEDICATION WAS PAUSED; NEW TUBING WAS SET UP. THE OLD TUBING THAT WAS LEAKING WAS SAVED AND GIVEN TO MATERIALS MANAGEMENT TO RETURN TO MANUFACTURER. [REDACTED]: ON [REDACTED] AT 0010 THE RN WENT TO MOVE THE IV POLE AND NOTICED THAT IT WAS WET. THEN INSPECTED TUBING AND NOTED THAT IT WAS THE MORPHINE CONTINUOUS LINE THAT WAS LEAKING. WHEN THE NEW LINE WAS PRIMED NOTICED THAT THE NEW TUBING WAS ALSO LEAKING. PRIMED ANOTHER SET AND THAT ONE WAS NOT LEAKING. LOT# FOR BOTH PRODUCTS 13924459, PRODUCT LABEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199237 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING A 60" (152 CM) APPX 2.2 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK, 0.2 MICRON FILTER, SPIN LUER WHERE THE REPORTER STATED THAT THAT "RN NOTED THE IV GLUCOSE TOLERANCE TEST (GTT) TUBING USED TO ADMINISTER FENTANYL TO THE PATIENT TO BE INCREASING IN VOLUME ON THE SYRINGE PUMP. THE SYRINGE PUMP ALARMED "OCCLUSION" AT 1300, AND THIS RN NOTED THERE TO BE CLEAR DRIPS COMING OFF OF THE OUTSIDE OF THE IV TUBING NEAR THE STOPCOCK ON THE GLUCOSE TOLERANCE TEST (GTT) TUBING. THE MEDICATION WAS PAUSED; NEW TUBING WAS SET UP." THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080030 ↗
• MalfunctionSep 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 60" (152 CM) APPX 2.2 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK, 0.2 MICRON FILTER, SPIN LUER WHERE THE CUSTOMER REPORTED THAT AT 0010 THE NURSE WENT TO MOVE THE IV POLE AND NOTICED THAT IT WAS WET. THE CUSTOMER THEN INSPECTED TUBING AND NOTED THAT IT WAS THE MORPHINE CONT. LINE THAT WAS LEAKING. WHEN THE NEW LINE WAS PRIMED, THEY NOTICED THAT THE NEW TUBING WAS ALSO LEAKING. THEY PRIMED ANOTHER SET AND THAT ONE WAS NOT LEAKING. THERE WAS PATIENT INVOLVEMENT; THE PATIENT WAS IRRITABLE DUE TO LACK OF MORPHINE OR BEING UNDER HYPOTHERMIC PROTOCOL. THE CUSTOMER REPORTED 2 INCIDENTS.

  Patient problems: Irritability; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22989352 ↗

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-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-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-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
• Z-0231-2021 · Jul 6, 2020 · Terminated
  10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709080796(17)241201(30)50(10)4536743; (01)1088770908
• Z-0230-2021 · Jul 6, 2020 · Terminated
  114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valves, Rotating Luer, 2 Exts. 1 unit per pouch, 25 pouches per
• 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-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-0206-2021 · Jul 6, 2020 · Terminated
  60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit p
• Z-0236-2021 · Jul 6, 2020 · Terminated
  7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)1088770906

…and 173 more.