ICU Medical A1003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709051034), received between Aug 9, 2023 and Mar 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 6" (15 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, NANOCLAVE® T-CONNECTOR, ROTATING LUER WAS FOUND TO LEAK DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT THE PATIENT'S WHITE LUMEN WAS LEAKING AS EVIDENCED BY WETNESS ON THE CENTRAL VENOUS LINE (CVL) VEST AS WELL AS SEEN WHEN FLUSHING. THE CAP AND TUBING CHANGE WAS COMPLETED IMMEDIATELY, AND THE WHITE LUMEN WAS CAPPED ALTHOUGH THE LUER LOCK WAS STILL NOT FULLY SECURE. WHITE LUMEN WAS NOT USED FOR THE REMAINDER OF THE SHIFT AND A COMPUTERIZED AXIAL TOMOGRAPHY( CAT) TEAM CONSULT WAS PLACED TO EVALUATE THE ISSUE IN THE MORNING. THE CAT TEAM REVIEWED AND INDICATED THE ISSUE WAS THE T CONNECTOR WAS SWIVELING AND NOT CONNECTING CORRECTLY TO THE LUMEN. THE T CONNECTOR DID NOT HAVE ENOUGH RIDGES TO TIGHTEN ONTO THE END OF THE LUMEN. THEIR TEAM NOTICED THE ISSUE SOME TIME AGO THAT THE T CONNECTORS WEREN¿T FITTING WELL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528887 ↗
• MalfunctionAug 9, 2023Material Separation; Material Separation

  THE INCIDENT INVOLVED A 6" (15 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, NANOCLAVE® T-CONNECTOR, ROTATING LUER. IT WAS REPORTED THAT THE CLAVE VALVE DISENGAGED FROM THE MECHANISM. THE EVENT OCCURRED WHEN CHANGING FLUIDS AND WAS NOTICED IMMEDIATELY UPON CONNECTING. IT WAS THEN REMOVED AND A SECOND PRODUCT WAS USED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491221 ↗

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-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-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-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-0202-2021 · Jul 6, 2020 · Terminated
  8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(
• 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)
• Z-0241-2021 · Jul 6, 2020 · Terminated
  6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709087719(17)250101(30)50(10)4558621;(01)10887709087719(17)2501
• 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-0224-2021 · Jul 6, 2020 · Terminated
  3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50
• Z-0259-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI: (01)1

…and 173 more.