ICU Medical A1134Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00887709069077), received between Oct 3, 2023 and Apr 29, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Break; Break

  A COMPLAINT WAS RECEIVED REGARDING A TO A 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, ANTI-SIPHON VALVE, 0.2 MICRON FILTER, LUER LOCK THAT EXPERIENCED BREAKAGE DURING PATIENT USE. THE REPORTER STATED THAT WHEN CHANGING FLUIDS AND SPIKING PN BAG, TUBING (SINGLE LUMEN TPN TUBING SET) GOT FAULTY WITH ONE OF THE TUBES BREAKING OFF. THEN, NEONATAL NURSE PRACTITIONER WAS CONTACTED AT 17:43 AND WAS TOLD TO USE NEW TUBING FOR PN BAG. CRITICAL NURSE WAS NOTIFIED OF INCIDENT, FAULTY TUBING WAS DELIVERED TO THE CHARGE NURSE OFFICE AND COLLECTED BY MANAGER. THE EVENT DATE OCCURRED ON (B)(6) 2025 DURING PATIENT USE. THUS, THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931418 ↗
• MalfunctionMar 31, 2025Break; Break

  A COMPLAINT WAS RECEIVED REGARDING TO A 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, ANTI-SIPHON VALVE, 0.2 MICRON FILTER, LUER LOCK THAT EXPERIENCED BREAKAGE. THE REPORTER STATED THAT WHEN PULLING BACK ON NEW SYRINGE TO REFILL, THE LINE SNAPPED AND BROKE OFF OF WIDER PART OF PN TUBING. LINE IMMEDIATELY CLAMPED CLOSEST TO PICC. LINE CHANGED PERFORMED ON ALL LINES ASSOCIATED WITH PICC. ORDERED OVERNIGHT PN, PHARMACY DISTRIBUTED NEW LIPID SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731851 ↗
• MalfunctionMar 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT ON, AN UNSPECIFIED DATE, A 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE T-CONNECTOR, ANTI-SIPHON VALVE, 0.2 MICRON FILTER, LUER LOCK BROKE DURING PATIENT USE. THE REPORTER STATED THAT THE PARENTERAL NUTRITION (PN) TUBING LINE BROKE WHILE CHANGING THE SYRINGE. IT DID NOT COME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDED AND THERE WAS NO CHEMO. IT WAS STATED THAT THE LINE WAS CHANGED AND THERE WAS NO CHEMO SPILL. THE EVENT OCCURRED DURING PATIENT USE AND NO ONE WAS HARMED AS A RESULT OF THE EVENT. THE EVENT WAS NOTED DURING THE CHANGING OF THE SYRINGE, TO REFILL. THERE WAS NO BLOOD LOSS OR BLEED BACK. THE FILTER WAS NOT REPLACED AND THERAPY WAS NOT RESUMED. THE SALINE WAS NOT REPLACED. THERE WAS NO HOLE, CUT, TEARS, OR ANY DEFECT NOTED BEFORE THE BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569261 ↗
• MalfunctionJan 2, 2025Disconnection; Separation Problem; Disconnection; Separation Problem

  THE EVENT INVOLVED A 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, ANTI-SIPHON VALVE, 0.2 MICRON FILTER, LUER LOCK WHERE THE CUSTOMER REPORTED THAT THE NEONATAL INTENSIVE CARE UNIT (NICU) HAD A PN LINE THAT BROKE OFF WHEN THEY WERE REFILLING THE SYRINGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054246 ↗
• MalfunctionSep 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT TWO 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, ANTI-SIPHON VALVE, 0.2 MICRON FILTER, LUER LOCK DEVICES WERE FOUND TO DISCONNECT DURING PATIENT USE. THE REPORT STATES "SNAP WHERE THE SYRINGE CONNECTS." THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176107 ↗
• InjuryAug 20, 2024Material Separation; Material Separation

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, ANTI-SIPHON VALVE, 0.2 MICRON FILTER, LUER LOCK. IT WAS REPORTED THAT SEVERAL TUBING SNAPS AT THE ONE-WAY VALVE WHEN THE PATIENT WAS RECEIVING IVF. THERE WAS PATIENT INVOLVEMENT, AND NO HUMAN HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20008562 ↗
• MalfunctionOct 5, 2023Material Separation; Material Separation

  THE REPORTED COMPLAINT INVOLVED A 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, ANTI-SIPHON VALVE, 0.2 MICRON FILTER, LUER LOCK. IT WAS REPORTED THAT THE THIN TUBING (THAT CONNECTS THE SYRINGE TO THE MAIN BAG OF FLUID) SNAPPED OFF WHILE CHANGING THE SYRINGE (WHEN TWISTING OFF THE OLD SYRINGE) ON THE 'PN' (POSSIBLY TPN, TOTAL PARENTERAL NUTRITION). THE EVENT WAS REPORTED TO HAVE OCCURRED 'BEFORE INFUSING, NEW TUBING'. ALTHOUGH THERE WAS PATIENT INVOLVEMENT, THERE WAS NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882189 ↗
• MalfunctionOct 3, 2023Separation Problem; Separation Problem

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, ANTI-SIPHON VALVE, 0.2 MICRON FILTER, LUER LOCK WHERE IT WAS REPORTED THAT WHILE CHANGING THE SYRINGE ON THE PARENTERAL NUTRITION (PN) AND WENT TO TWIST THE OLD SYRINGE OFF, THE THIN TUBING (THAT CONNECTS THE SYRINGE TO THE MAIN BAG OF FLUID) SNAPPED OFF. THE TUBING WAS CHANGED. THERE WAS UNKNOWN PATIENT INVOLVED AND UNKNOWN HARM. THIS IS THE SECOND OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17863094 ↗
• MalfunctionOct 3, 2023Separation Problem; Separation Problem

  THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, ANTI-SIPHON VALVE, 0.2 MICRON FILTER, LUER LOCK WHERE IT WAS REPORTED THAT WHILE CHANGING THE SYRINGE ON THE PARENTERAL NUTRITION (PN) AND WENT TO TWIST THE OLD SYRINGE OFF, THE THIN TUBING (THAT CONNECTS THE SYRINGE TO THE MAIN BAG OF FLUID) SNAPPED OFF. THE TUBING WAS CHANGED. THERE WAS UNKNOWN PATIENT INVOLVED AND UNKNOWN HARM. THIS IS THE FIRST OF TWO EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17863086 ↗

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-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-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-0256-2021 · Jul 6, 2020 · Terminated
  149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709074696(17)250101(30)25(10)4711277;
• Z-0260-2021 · Jul 6, 2020 · Terminated
  124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709034
• Z-0239-2021 · Jul 6, 2020 · Terminated
  APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(1
• Z-0225-2021 · Jul 6, 2020 · Terminated
  112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705.
• Z-0189-2021 · Jul 6, 2020 · Terminated
  9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(0
• 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-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

…and 173 more.