ICU Medical B6008Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887709011014), received between Apr 1, 2020 and Sep 15, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Crack; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776663 ↗
• MalfunctionMay 19, 2025Fracture; Fracture

  THE EVENT INVOLVED A 0.2 MICRON PEDIATRIC FILTER, ROTATING LUER WHERE IT WAS REPORTED WHEN REMOVING A SYRINGE LINE WITH A 0.2 MICRON FILTER ATTACHED, THE END OF THE FILTER BROKE OFF INTO THE CAP POST NIVOLUMAB INFUSION. UNABLE TO USE CAP AFTERWARDS, REQUIRED A CAP CHANGE IN ORDER TO HEPARIN LOCK THE PORT. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045063 ↗
• MalfunctionApr 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A 0.2 MICRON PEDIATRIC FILTER, ROTATING LUER THAT EXPERIENCED LEAKAGE DURING PATIENT USE. THE REPORTER STATED THAT PATIENT RUNNING ATG WHEN 0.2-MICRON FILTER BETWEEN BI-FUSE AND STRAIGHT LINE BEGAN LEAKING. ESTIMATED 5 MLS LOST BASED ON WHEN PARENTS NOTICED THE LEAK AND THE WET SPOT ON PATIENT'S CLOTHING. THE EVENT DATE WAS ON (B)(6) 2025 AT 14:30 DURING 8B (BONE MARROW TRANSPLANT). THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922033 ↗
• MalfunctionJan 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A 0.2 MICRON FILTER THAT LEAKED CHEMOTHERAPY (TEMSIROLIMUS) FROM A CRACK ALONG THE EDGE OF THE FILTER (WHERE THE FILTER CONNECTS TO THE INFUSION SET). THE LINE WAS PRIMED WITH 0.9% NORMAL SALINE PRE, WITH NO LEAKING NOTED AT THIS TIME; CHEMOTHERAPY WAS STARTED. AT THE END OF THE INFUSION (30 ¿ 60 MINUTES), THE RN WAS CALLED TO THE ROOM TO HANG THE FLUSH AND NOTICED THE BEDDING WAS SATURATED WITH CHEMOTHERAPY. THE INFUSION WAS STOPPED, A SPILL KIT WAS OBTAINED, AND THE PATIENT¿S BEDDING WAS CHANGED. THE PATIENT¿S PORT WAS HEPARIN LOCKED AND THE DECISION WAS MADE NOT TO REPEAT THE DOSE AS IT WAS UNKNOWN WHEN THE LEAK BEGAN AND HOW MUCH OF THE DRUG THE PATIENT RECEIVED. THERE WAS PATIENT INVOLVEMENT, NO BLOOD LOSS OR BLEED BACK AND NO PATIENT HARM REPORTED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 11108751 ↗
• MalfunctionApr 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE DATE OF THE EVENT IS UNKNOWN. THE EVENT INVOLVED A IS 0.2 MICRON PEDIATRIC FILTER, ROTATING LUER THAT THE FILTER STARTS LEAKING (ETOPOSIDE) OR SHOWS SIGNS OF CRACKING. IT WAS FURTHER ADDED THAT THE LEAK OCCURS AT THE JOINT BETWEEN THE FILTER AND THE IV TUBING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913559 ↗

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-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-0258-2021 · Jul 6, 2020 · Terminated
  112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1 Ext. 1 unit per pouch, 25 pouches per case
• Z-0232-2021 · Jul 6, 2020 · Terminated
  58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches per case. UDI:(01)10887709095298(17)250101(30)25(10)4573460
• 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-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-0211-2021 · Jul 6, 2020 · Terminated
  5.5" (14 cm) Appx 0.50 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)
• 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-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

…and 173 more.