ICU Medical MC33424Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709038677), received between Jan 20, 2025 and Jan 20, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 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.

• MalfunctionJan 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 60" (152 CM) APPX 1.8 ML, SMALLBORE EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP (BLUE), LUER LOCK WHERE IT WAS REPORTED THAT THEY HAD MULTIPLE ISSUES OF SYRINGE TUBING LEAKING AT THE MICROCLAVE. THE EVENT OCCURRED WHILE PROVIDING PATIENT CARE. PER THE REPORT, ¿RN PRIMED NEW SYRINGE MEDICATION LINE TO GIVE SCHEDULED LASIX. NO LEAKAGE NOTED DURING PRIME. WHILE HOOKING UP THE FLUSH AND PUSHING A TAD, RN REALIZED THE TUBING WAS LEAKING FROM THE MICROCLAVE. MICROCLAVE REMOVED AND FLUSH HOOKED DIRECTLY TO TUBING TO SEE IT WAS A MICROCLAVE ISSUE VS TUBING ISSUES, TUBING CONTINUED TO LEAK. ANOTHER SYRINGE TUBING WAS RETRIEVED FROM BEDSIDE CART WITH SAME LOT NUMBER (LOT: 14063312), SAME ISSUE NOTED. EVERYTHING APPEARS FINE WHEN FLUSHING WITH NO PRESSURE, BUT IF THERE IS ANY RESISTANCE ON THE LINE (EX. CLAMPED OR INFUSING INTO A LINE WITH OTHER FLUIDS RUNNING) THE TUBING LEAKS AT THE MICROCLAVE WITH A SLOW DRIP. TUBING REMOVED AND OTHER SYRINGE TUBING RETRIEVED FROM SUPPLY ROOM WITH NO PROBLEMS NOTED.¿ THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT/PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193196 ↗
• MalfunctionJan 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 60" (152 CM) APPX 1.8 ML, SMALLBORE EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP (BLUE), LUER LOCK. THE REPORTER STATED THAT THEY HAD MULTIPLE ISSUES OF SYRINGE TUBING LEAKING AT THE MICROCLAVE. THE EVENT OCCURRED WHILE PROVIDING PATIENT CARE. PER THE REPORT, ¿RN PRIMED NEW SYRINGE MEDICATION LINE TO GIVE SCHEDULED LASIX. NO LEAKAGE NOTED DURING PRIME. WHILE HOOKING UP THE FLUSH AND PUSHING A TAD, RN REALIZED THE TUBING WAS LEAKING FROM THE MICROCLAVE. MICROCLAVE REMOVED AND FLUSH HOOKED DIRECTLY TO TUBING TO SEE IT WAS A MICROCLAVE ISSUE VS TUBING ISSUES, TUBING CONTINUED TO LEAK. ANOTHER SYRINGE TUBING WAS RETRIEVED FROM BEDSIDE CART WITH SAME LOT NUMBER (LOT 14063312), SAME ISSUE NOTED. EVERYTHING APPEARS FINE WHEN FLUSHING WITH NO PRESSURE, BUT IF THERE IS ANY RESISTANCE ON THE LINE (EX. CLAMPED OR INFUSING INTO A LINE WITH OTHER FLUIDS RUNNING) THE TUBING LEAKS AT THE MICROCLAVE WITH A SLOW DRIP. TUBING REMOVED AND OTHER SYRINGE TUBING RETRIEVED FROM SUPPLY ROOM WITH NO PROBLEMS NOTED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT/PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191455 ↗

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: B92
• 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-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-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-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-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)10887709
• 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-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-0238-2021 · Jul 6, 2020 · Terminated
  11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)1
• Z-0217-2021 · Jul 6, 2020 · Terminated
  Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709084435(17)250101(30)50(10
• 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 Intrava

…and 173 more.