ICU Medical B4078Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709008847), received between Mar 3, 2026 and Mar 9, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Fluid/Blood Leak

  THE EVENT OCCURRED ON UNKNOWN DATE INVOLVING A 4 GANG 4-WAY STOPCOCK W/BASEPLATE. IT WAS REPORTED THAT THE DEVICE WAS LEAKING AT CONNECTION POINT WITH TAPE. THE PATIENT WAS ON A SIGNIFICANT VASOACTIVE SUPPORT- HIGH CONCERN DUE TO INSTABILITY OF PATIENT AND REQUIRING LINE CHANGE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM DUE TO TRAIN (STOPCOCK) ITSELF BUT BECAUSE PATIENT WAS EXTREMELY UNSTABLE. ANY SMALL CHANGE; PATIENT DECOMPENSATE SO CHANGING LINE EARLY DUE TO A LEAK WAS CONCERNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552144 ↗
• MalfunctionMar 9, 2026Fluid/Blood Leak

  VOID JUSTIFICATION: THIS RECORD WAS VOIDED SINCE THIS IS A DUPLICATE OF EXISTING RECORD UNDER CN-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543235 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A 4 GANG 4-WAY STOPCOCK W/BASEPLATE WHERE IT WAS REPORTED THAT THE PRODUCT WAS LEAKING BETWEEN 2ND AND 3RD STOPCOCK. BOTH ARE INFUSING VASOACTIVE OF MILRINONE AND EPINEPHRINE. THERE WAS PATIENT INVOLVEMENT, AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527725 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  THE EVENT INVOLVED A 4 GANG, 4-WAY, STOPCOCK W/BASEPLATE WHERE THE CUSTOMER REPORTED THAT THE PRODUCT WAS LEAKING BETWEEN THE FIRST AND SECOND STOPCOCK; BOTH WERE INFUSING VASOACTIVE OF MILRINONE AND EPINEPHRINE. PATIENT ON SIGNIFICANT VASOACTIVE SUPPORT, HIGH CONCERN DUE TO INSTABILITY OF PATIENT AND REQUIRING LINE CHANGE. NO HARM DUE TO TRAIN (STOPCOCK) ITSELF, BUT BECAUSE THE PATIENT WAS EXTREMELY UNSTABLE, NEED TO CHANGE LINE WAS OF HIGH CONCERN DUE TO LEAKING. ANY SMALL CHANGE EQUALS PATIENT DECOMPENSATES, SO HAVING TO CHANGE LINE EARLY DUE TO LEAKING WAS CONCERNING. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497837 ↗

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-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-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-0208-2021 · Jul 6, 2020 · Terminated
  12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(3
• 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-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-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-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-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-0207-2021 · Jul 6, 2020 · Terminated
  13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801; (01)

…and 173 more.